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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05653219
Registration number
NCT05653219
Ethics application status
Date submitted
23/11/2022
Date registered
16/12/2022
Titles & IDs
Public title
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
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Scientific title
A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2)
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Secondary ID [1]
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0
CVAY736Q12301
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Universal Trial Number (UTN)
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Trial acronym
VAYHIT2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Primary Immune Thrombocytopenia
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Condition category
Condition code
Blood
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0
0
0
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Haematological diseases
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Blood
0
0
0
0
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Other blood disorders
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Inflammatory and Immune System
0
0
0
0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Ianalumab
Treatment: Drugs - Eltrombopag
Treatment: Drugs - Placebo
Experimental: Treatment arm 1 - Participants will receive eltrombopag and ianalumab lower dose
Experimental: Treatment arm 2 - Participants will receive eltrombopag and ianalumab higher dose
Placebo comparator: Treatment arm 3 - Participants will receive eltrombopag and placebo
Treatment: Other: Ianalumab
Concentrate for solution for infusion for intravenous use
Treatment: Drugs: Eltrombopag
Film-coated tablet for oral use
Treatment: Drugs: Placebo
Concentrate for solution for infusion for intravenous use.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time from randomization until treatment failure
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Assessment method [1]
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Time from randomization until treatment failure is defined as the time from randomization date until the first of the following events indicative of treatment failure:
* platelet count below 30 G/L
* start of a new ITP treatment
* need for a rescue treatment
* ineligibility to taper or inability to discontinue eltrombopag
* death
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Timepoint [1]
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Randomization to until end of study (up to 39 months after randomization of last participant)
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Secondary outcome [1]
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Complete Response rate at each timepoint
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Assessment method [1]
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Percentage of participants with any platelet count of at least 100 G/L in the absence of rescue treatment or new ITP treatment
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Timepoint [1]
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Randomization to until end of study (up to 39 months after randomization of last participant)
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Secondary outcome [2]
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0
Response rate at each timepoint
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Assessment method [2]
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0
Percentage of participants with any platelet count of at least 50 G/L in the absence of rescue treatment or new ITP treatment
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Timepoint [2]
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0
Randomization to until end of study (up to 39 months after randomization of last participant)
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Secondary outcome [3]
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0
Best response rate across all timepoints
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Assessment method [3]
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Percentage of participants with a best response rate of either response or complete response
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Timepoint [3]
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Randomization to until end of study (up to 39 months after randomization of last participant)
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Secondary outcome [4]
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Time to first response/time to first complete response
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Assessment method [4]
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Time from randomization to date of first response and time from randomization to date of first complete response
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Timepoint [4]
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Time from randomization up to the longest observed treatment period duration
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Secondary outcome [5]
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Duration of response
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Assessment method [5]
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Time from achievement of response to treatment failure Stable response at 6 months
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Timepoint [5]
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Randomization to until end of study (up to 39 months after randomization of last participant)
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Secondary outcome [6]
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Stable response at 6 months
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Assessment method [6]
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Percentage of participants with at least 3 platelet count collected at month 6 between (study days 121 and 183 and at least 75% of platelet counts qualified as a response
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Timepoint [6]
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At 6 months
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Secondary outcome [7]
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Stable response at 1 year
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Assessment method [7]
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Percentage of participants with at least 2 platelet count collected at year 1 between (study days 296 and 379 and at least 66% of platelet counts qualified as a response
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Timepoint [7]
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0
At 1 year
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Secondary outcome [8]
0
0
Duration of complete response
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Assessment method [8]
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0
Time from achievement of complete response to loss of complete response stable response at 1 year period
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Timepoint [8]
0
0
Randomization to end of study (up to 39 months after randomization of last participant)
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Secondary outcome [9]
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Rate of participants who successfully taper and discontinue eltrombopag in each treatment arm
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Assessment method [9]
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Probability to be treatment failure-free (as defined for the primary efficacy endpoint)
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Timepoint [9]
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0
up to week 24
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Secondary outcome [10]
0
0
Percentage of participants with bleeding events according to World Health Organization (WHO)
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Assessment method [10]
0
0
Percentage of participants reporting bleeding events according to WHO bleeding scale
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Timepoint [10]
0
0
Randomization to until end of study (up to 39 months after randomization of last participant)
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Secondary outcome [11]
0
0
Number of participants receiving rescue treatment
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Assessment method [11]
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0
Number of participants who are in need of rescue treatment in each treatment arm
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Timepoint [11]
0
0
Randomization to until end of study (up to 39 months after randomization of last participant)
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Secondary outcome [12]
0
0
Percentage of participants receiving rescue treatment
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Assessment method [12]
0
0
Percentage of participants who are in need of rescue treatment
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Timepoint [12]
0
0
Randomization to until end of study (up to 39 months after randomization of last participant)
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Secondary outcome [13]
0
0
Change from baseline in the frequency of CD19+ B-cell counts
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Assessment method [13]
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0
Post-baseline frequency of CD19+ B-cell counts (percentage within CD45) compared to baseline
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Timepoint [13]
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0
Randomization to until end of study (up to 39 months after randomization of last participant)
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Secondary outcome [14]
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0
Change from baseline in the absolute number of CD19+ B-cell counts
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Assessment method [14]
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Post-baseline absolute number of CD19+ B-cell counts compared to baseline
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Timepoint [14]
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0
Randomization to until end of study (up to 39 months after randomization of last participant)
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Secondary outcome [15]
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Change from baseline on T-score of the PROMIS SF v1.0 Fatigue 13a
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Assessment method [15]
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The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Fatigue 13a includes 13 items that assess fatigue in adults.
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Timepoint [15]
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0
From screening (baseline) until end of study (up 39 months after randomization of last participant)
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Secondary outcome [16]
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0
Change from baseline in ITP PAQ domain scores of symptoms, fatigue, bother (uncomfortable), activity
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Assessment method [16]
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The ITP-PAQ is a 44 item scale for measuring HRQoL in adults with ITP across ten scales: Symptoms, Bother-Physical Health, Fatigue/Sleep, Activity, Fear, Psychological Health, Work, Social Activity, Women´s Reproductive Health, overall QoL. Each item is rated on a Likert type scale. Each scale is scored from 0 to 100. Higher scores represent better HRQoL.
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Timepoint [16]
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0
From screening (baseline) until end of study (up 39 months after randomization of last participant)
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Secondary outcome [17]
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Time to first occurence of B-cell recovery defined as =80% of baseline =50 cells/µL
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Assessment method [17]
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Time to B-cell recovery defined as =80% of baseline or =50 cells/µL
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Timepoint [17]
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Randomization to until end of study (up to 39 months after randomization of last participant)
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Secondary outcome [18]
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Change from baseline in immunoglobulins
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Assessment method [18]
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Change from baseline in immunoglobulin levels
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Timepoint [18]
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Randomization to until end of study (up to 39 months after randomization of last participant)
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Secondary outcome [19]
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PK parameters: AUClast
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Assessment method [19]
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AUClast: Area under the curve from time zero to the last measurable concentration sampling time (tlast)
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Timepoint [19]
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After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
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Secondary outcome [20]
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PK parameters: AUCtau
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Assessment method [20]
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AUCtau: Area under the curve calculated to the end of a dosing interval (tau)
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Timepoint [20]
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After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
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Secondary outcome [21]
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PK parameters: Cmax
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Assessment method [21]
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Maximum (peak) observed plasma, blood, serum or other body fluid drug concentration
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Timepoint [21]
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0
After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
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Secondary outcome [22]
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0
PK parameters: Tmax
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Assessment method [22]
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0
Time to reach maximum (peak) observed plasma, blood, serum or other body fluid drug concentration
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Timepoint [22]
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0
After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
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Secondary outcome [23]
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PK parameters: Accumulation ratio Racc
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Assessment method [23]
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Accumulation ratio calculated using AUC values obtained after the last and first dose
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Timepoint [23]
0
0
After last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
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Secondary outcome [24]
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0
Incidence of anti-ianalumab antibodies in serum (ADA assay) over time
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Assessment method [24]
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Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assessing the immunogenicity of ianalumab
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Timepoint [24]
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0
up to week 33
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Secondary outcome [25]
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0
Titer of anti-ianalumab antibodies in serum (ADA assay) over time
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Assessment method [25]
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Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assessing the immunogenicity of ianalumab
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Timepoint [25]
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0
up to week 33
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Eligibility
Key inclusion criteria
Key Inclusion criteria
1. Male or female patients aged 18 years and older on the day of signing the informed consent.
2. A signed informed consent must be obtained prior to participation in the study.
3. A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG.
4. Patient with platelet count <30G/L (whom eltrombopag is clinically indicated as per physician's discretion) and with no contraindication to receive eltrombopag
Key
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria
1. ITP patients who received second-line ITP treatments (other than steroid therapy± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (max one week) before screening are eligible.
2. Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia, (patients with low grade anemia related to bleeding or iron deficiency are eligible).
3. Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters
4. Patients with current or history of life-threatening bleeding
5. Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAb)-positive. HBcAb-positive patients can be enrolled if HBsAg negative, HBV DNA negative, no pre-existing liver fibrosis is present and antiviral prophylaxis is given
6. Patients with known active or uncontrolled infection requiring systemic treatment during screening period
7. Patients with hepatic impairment
8. Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid (=150 mg daily)
9. Female patients who are pregnant or nursing
Other protocol-defined inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/02/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
19/05/2028
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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0
Novartis Investigative Site - Clayton
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Recruitment hospital [2]
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Novartis Investigative Site - Parkville
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Arizona
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Country [2]
0
0
United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Colorado
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0
0
United States of America
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State/province [4]
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Florida
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Country [5]
0
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United States of America
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State/province [5]
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Illinois
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Country [6]
0
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United States of America
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State/province [6]
0
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Indiana
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Country [7]
0
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United States of America
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State/province [7]
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Massachusetts
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Country [8]
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United States of America
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Missouri
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United States of America
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Montana
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United States of America
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State/province [10]
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New Jersey
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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State/province [14]
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Pennsylvania
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0
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United States of America
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State/province [15]
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Texas
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Country [16]
0
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United States of America
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State/province [16]
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Utah
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Country [17]
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Argentina
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State/province [17]
0
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Buenos Aires
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Country [18]
0
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Austria
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State/province [18]
0
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Linz
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Country [19]
0
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Austria
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State/province [19]
0
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Vienna
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Country [20]
0
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Austria
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State/province [20]
0
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Wels
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Country [21]
0
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Belgium
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State/province [21]
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Leuven
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0
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Belgium
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Roeselare
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0
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Belgium
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State/province [23]
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Yvoir
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0
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China
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State/province [24]
0
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Guangdong
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0
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China
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Hubei
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0
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China
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Jiangsu
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0
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China
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Shandong
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0
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China
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Zhejiang
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0
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China
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0
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Beijing
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0
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China
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0
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Ji Nan
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0
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China
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0
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Tianjin
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0
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Czechia
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0
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Czech Republic
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0
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Czechia
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Praha 10
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Czechia
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0
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Praha
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0
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France
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Cedex 09
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France
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Blois Cedex
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France
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Vandoeuvre Les Nancy
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0
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Germany
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Dresden
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Germany
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Giessen
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Germany
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Greifswald
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Germany
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Hannover
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Germany
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Jena
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Germany
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Koeln
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0
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Hungary
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0
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Budapest
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0
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Hungary
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0
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Debrecen
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0
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India
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0
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Uttarakhand
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0
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India
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0
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West Bengal
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0
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India
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Chandigarh
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Italy
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0
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BO
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0
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Italy
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0
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RM
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0
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Italy
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0
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TO
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0
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Italy
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0
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TS
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0
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Italy
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0
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VI
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0
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Japan
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0
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Aichi
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0
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Japan
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0
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Chiba
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0
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Japan
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0
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Kumamoto
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0
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Japan
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0
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Nagasaki
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0
0
Japan
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0
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Osaka
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Country [59]
0
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Japan
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State/province [59]
0
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Tokyo
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Country [60]
0
0
Japan
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0
0
Yamanashi
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0
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Japan
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0
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Aomori
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0
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Japan
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0
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Hiroshima
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0
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Korea, Republic of
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0
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Seocho Gu
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Korea, Republic of
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Jeollanam
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Korea, Republic of
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Seoul
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0
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Malaysia
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0
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Sabah
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Country [67]
0
0
Malaysia
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State/province [67]
0
0
Sarawak
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Country [68]
0
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Malaysia
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State/province [68]
0
0
Selangor
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Country [69]
0
0
Malaysia
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State/province [69]
0
0
Johor Bahru
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Country [70]
0
0
Malaysia
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State/province [70]
0
0
Kuala Lumpur
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Country [71]
0
0
Malaysia
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State/province [71]
0
0
Penang
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0
0
Malaysia
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State/province [72]
0
0
Pulau Pinang
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Country [73]
0
0
Mexico
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State/province [73]
0
0
Mexico CP
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0
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Mexico
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0
0
Michoacan
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0
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Mexico
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0
0
Nuevo Leon
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0
0
Netherlands
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0
0
Utrecht
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Norway
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Gralum
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Philippines
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Makati City
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Philippines
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Quezon
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Romania
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District 2
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Romania
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Bucharest
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Romania
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Craiova
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Romania
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Sibiu
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Romania
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Timisoara
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Singapore
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Singapore
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Spain
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Castilla Y Leon
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Spain
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Catalunya
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Spain
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Galicia
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Spain
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Madrid
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Spain
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Murcia
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Taiwan
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Kaohsiung
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Turkey
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TUR
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Turkey
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Ankara
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Turkey
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Aydin
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Turkey
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Edirne
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Turkey
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Izmir
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Turkey
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Samsun
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United Kingdom
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Cornwall
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United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Oxford
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United Kingdom
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.
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Trial website
https://clinicaltrials.gov/study/NCT05653219
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for public queries
Name
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Novartis Pharmaceuticals
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Address
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Phone
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1-888-669-6682
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05653219