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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05024058




Registration number
NCT05024058
Ethics application status
Date submitted
23/08/2021
Date registered
27/08/2021

Titles & IDs
Public title
Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines
Scientific title
A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Secondary ID [1] 0 0
2020-003018-11
Secondary ID [2] 0 0
CQGE031E12301
Universal Trial Number (UTN)
Trial acronym
PEARL-PROVOKE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Inducible Urticaria 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ligelizumab
Other interventions - Placebo

Experimental: Ligelizumab low dose, symptomatic dermographism group - Ligelizumab low dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism

Experimental: Ligelizumab high dose, symptomatic dermographism - Ligelizumab high dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism

Placebo comparator: Placebo SC q4W, symptomatic dermographism - Placebo subcutaneous injection every 4 weeks in participants with symptomatic dermographism

Experimental: Ligelizumab low dose, cold urticaria - Ligelizumab low dose subcutaneous injection every 4 weeks in participants with cold urticaria

Experimental: Ligelizumab high dose, cold urticaria - Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cold urticaria

Placebo comparator: Placebo SC q4w, cold urticaria - Placebo subcutaneous injection every 4 weeks in participants with cold urticaria

Experimental: Ligelizumab high dose, cholinergic urticaria - Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cholinergic urticaria

Placebo comparator: Placebo SC q4w, cholinergic urticaria - Placebo subcutaneous injections every 4 weeks in participants with cholinergic urticaria


Treatment: Drugs: Ligelizumab
Ligelizumab treated groups and arms

Other interventions: Placebo
Placebo treated groups and arms
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Total Fric Score in Participants With Symptomatic Dermographism
Timepoint [1] 0 0
Baseline, Week 12
Primary outcome [2] 0 0
Change From Baseline in Critical Temperature Threshold in Participants With Cold Urticaria
Timepoint [2] 0 0
Baseline, Week 12
Primary outcome [3] 0 0
Change From Baseline in Itch Numerical Rating Scale in Participants With Cholinergic Urticaria
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Proportion of Participants With Symptomatic Dermographism With Total Fric Score = 0
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Change From Baseline in Itch Numerical Rating Scale in Participants With Symptomatic Dermographism
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Proportion of Participants With Cold Urticaria With Complete Response (no Itch or Hives) to the TempTest
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Change From Baseline in Itch Numerical Rating Scale in Participants With Cold Urticaria
Timepoint [4] 0 0
Baseline, Week 12
Secondary outcome [5] 0 0
Proportion of Participants With Cholinergic Urticaria With Itch Numerical Rating Scale =0
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Proportion of Participants With Cholinergic Urticaria With Physician Global Assessment of Severity of Hives (PGA - Hive Score) =0
Timepoint [6] 0 0
Week 12

Eligibility
Key inclusion criteria
* Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for = 4 months.

* Diagnosis of CINDU (symptomatic dermographism, cold urticaria or cholinergic urticaria) inadequately controlled with H1-AH at local label approved doses at the time of randomization, as defined by all of the following:
* Positive response (i.e development of symptoms) to triggers despite treatment with H1-AH
* Positive response (i.e. development of symptoms) to provocation test on day of randomization
* Participants must be able to physically perform the protocol defined provocation test specific to the participant's CINDU.
* Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
* Willing and able to complete a daily symptom eDiary as per protocol requirement and adhere to the study visit schedules
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of hypersensitivity to any of the study drugs or its components or to drugs of similar chemical classes or to the provocation test or items used in provocation tests

* Participants who have concomitant CSU at screening
* Participants who have a familial form of the target CINDU that is being considered for the participant's inclusion in this study
* Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study
* Diseases, other than chronic inducible urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
* Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
* Prior exposure to ligelizumab, omalizumab and or other anti-IgE therapies

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/08/2022
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - East Melbourne
Recruitment hospital [2] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3002 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Indiana
Country [2] 0 0
United States of America
State/province [2] 0 0
South Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah
Country [5] 0 0
Greece
State/province [5] 0 0
Athens
Country [6] 0 0
Hungary
State/province [6] 0 0
Hajdu Bihar
Country [7] 0 0
Hungary
State/province [7] 0 0
Pecs
Country [8] 0 0
Hungary
State/province [8] 0 0
Szeged
Country [9] 0 0
Russian Federation
State/province [9] 0 0
Izhevsk
Country [10] 0 0
Russian Federation
State/province [10] 0 0
Rostov On Don
Country [11] 0 0
Russian Federation
State/province [11] 0 0
Saint Petersburg
Country [12] 0 0
Russian Federation
State/province [12] 0 0
St Petersburg
Country [13] 0 0
Russian Federation
State/province [13] 0 0
Stavropol
Country [14] 0 0
Slovakia
State/province [14] 0 0
Kezmarok
Country [15] 0 0
Slovakia
State/province [15] 0 0
Svidnik
Country [16] 0 0
Spain
State/province [16] 0 0
Andalucia
Country [17] 0 0
Spain
State/province [17] 0 0
Catalunya
Country [18] 0 0
Spain
State/province [18] 0 0
Comunidad Valenciana
Country [19] 0 0
Taiwan
State/province [19] 0 0
Taipei
Country [20] 0 0
Turkey
State/province [20] 0 0
Ankara
Country [21] 0 0
Turkey
State/province [21] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05024058