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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
15/10/2024

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.
Trial website
https://clinicaltrials.gov/study/NCT04895696
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04895696