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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04895696




Registration number
NCT04895696
Ethics application status
Date submitted
19/05/2021
Date registered
20/05/2021
Date last updated
19/08/2024

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
Scientific title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus
Secondary ID [1] 0 0
2023-504320-25-00
Secondary ID [2] 0 0
IM026-024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

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

Experimental: Afimetoran: Dose 1 -

Experimental: Afimetoran: Dose 2 -

Experimental: Afimetoran: Dose 3 -

Placebo comparator: Placebo -


Treatment: Drugs: Afimetoran
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
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
Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48
Timepoint [1] 0 0
Up to 48 Weeks
Secondary outcome [1] 0 0
Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48
Timepoint [1] 0 0
Up to 48 Weeks
Secondary outcome [2] 0 0
Proportion of participants who achieve an SRI(4) response at Week 24
Timepoint [2] 0 0
Up to 24 Weeks
Secondary outcome [3] 0 0
Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48
Timepoint [3] 0 0
Up to 48 Weeks
Secondary outcome [4] 0 0
Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index; Activity (CLASI-A) score = 10 at baseline who achieve a decrease of = 50% from baseline CLASI-A score (CLASI-50) response at Week 24 and Week 48
Timepoint [4] 0 0
Up to 48 Weeks
Secondary outcome [5] 0 0
Proportion of participants with 6 or more swollen joints and 6 or more tender joints at baseline who achieve a = 50% reduction from baseline in both swollen and tender joints at Week 24 and Week 48
Timepoint [5] 0 0
Up to 48 Weeks
Secondary outcome [6] 0 0
Mean change from baseline in swollen joint count using the 28-joint count at Week 24 and Week 48 in participants with = 2 swollen joints at baseline
Timepoint [6] 0 0
Up to 48 Weeks
Secondary outcome [7] 0 0
Mean change from baseline in tender joint count at Week 24 and Week 48 using the 28- joint count in participants with = 2 tender joints at baseline
Timepoint [7] 0 0
Up to 48 Weeks
Secondary outcome [8] 0 0
Change from baseline in PGA score of disease activity at Week 24 and Week 48
Timepoint [8] 0 0
Up to 48 Weeks
Secondary outcome [9] 0 0
Proportion of participants who achieve CS reduction or maintenance to = 7.5 mg per day at Week 48
Timepoint [9] 0 0
Up to 48 Weeks
Secondary outcome [10] 0 0
Change in participant reported disease activity from baseline to Week 24 and Week 48 according to the 36-item Short Form Health Questionnaire (SF-36)
Timepoint [10] 0 0
Up to 48 Weeks
Secondary outcome [11] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [11] 0 0
Up to 100 Weeks
Secondary outcome [12] 0 0
Number of participants with Serious Adverse Events (SAEs)
Timepoint [12] 0 0
Up to 100 Weeks
Secondary outcome [13] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [13] 0 0
Up to 100 Weeks
Secondary outcome [14] 0 0
Number of participants with physical examination abnormalities
Timepoint [14] 0 0
Up to 100 Weeks
Secondary outcome [15] 0 0
Number of participants with vital sign abnormalities
Timepoint [15] 0 0
Up to 100 Weeks
Secondary outcome [16] 0 0
Number of participants with electrocardiogram (ECG) abnormalities
Timepoint [16] 0 0
Up to 52 Weeks

Eligibility
Key inclusion criteria
* Diagnosed = 12 weeks before the screening visit and qualify as having SLE according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at the screening visit
* Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody = 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody.
* Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score = 6 points and clinical Hybrid SLEDAI score = 4 points with joint involvement and/or rash
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active severe lupus nephritis (LN) as assessed by the investigator
* Active or unstable neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI
* Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
* Antiphospholipid Syndrome

Other protocol-defined inclusion/exclusion criteria apply

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/04/2029
Actual
Sample size
Target
268
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0063 - Botany
Recruitment hospital [2] 0 0
Westmead Hospital-Department of Clinical Immunology and Allergy - Westmead
Recruitment hospital [3] 0 0
Local Institution - 0066 - Maroochydore
Recruitment hospital [4] 0 0
Local Institution - 0065 - Woodville
Recruitment hospital [5] 0 0
Local Institution - 0062 - Camberwell
Recruitment hospital [6] 0 0
Local Institution - 0064 - Ivanhoe
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3124 - Camberwell
Recruitment postcode(s) [6] 0 0
3079 - Ivanhoe
Recruitment outside Australia
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United States of America
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Alabama
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California
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Taipei
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Bradford
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Edinburgh
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT04895696