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A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

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ClinicalTrials.gov Identifier: NCT04895696
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : November 15, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Afimetoran Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 11, 2021
Estimated Primary Completion Date : May 28, 2025
Estimated Study Completion Date : May 15, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Afimetoran: Dose 1 Drug: Afimetoran
Specified dose on specified days
Other Name: BMS-986256

Experimental: Afimetoran: Dose 2 Drug: Afimetoran
Specified dose on specified days
Other Name: BMS-986256

Experimental: Afimetoran: Dose 3 Drug: Afimetoran
Specified dose on specified days
Other Name: BMS-986256

Placebo Comparator: Placebo Other: Placebo
Specified dose on specified days




Primary Outcome Measures :
  1. Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48 [ Time Frame: Up to 48 Weeks ]

Secondary Outcome Measures :
  1. Proportion of participants that achieve an SRI(4) response with corticosteroids (CS) reduction and maintenance to ≤ 7.5 mg per day at Week 48 [ Time Frame: Up to 48 Weeks ]
  2. Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48 [ Time Frame: Up to 48 Weeks ]
  3. Proportion of participants who achieve an SRI(4) response without CS reduction and maintenance to ≤ 7.5 mg per day at Week 24 [ Time Frame: Up to 24 Weeks ]
  4. Proportion of participants who achieve an SRI(4) response with CS reduction and maintenance to ≤ 7.5 mg per day at Week 24 [ Time Frame: Up to 24 Weeks ]
  5. Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48 [ Time Frame: Up to 48 Weeks ]
  6. 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 [ Time Frame: Up to 48 Weeks ]
  7. 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 [ Time Frame: Up to 48 Weeks ]
  8. 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 [ Time Frame: Up to 48 Weeks ]
  9. 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 [ Time Frame: Up to 48 Weeks ]
  10. Change from baseline in PGA score of disease activity at Week 24 and Week 48 [ Time Frame: Up to 48 Weeks ]
    PGA = Physician Global Assessment of disease activity (score of "0" indicating no disease activity and higher scores indicating higher disease activity)

  11. Proportion of participants who achieve CS reduction or maintenance to ≤ 7.5 mg per day at Week 48 [ Time Frame: Up to 48 Weeks ]
  12. 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) [ Time Frame: Up to 48 Weeks ]
    The SF-36 was designed as an indicator of health status in population surveys, and health policy evaluations, and for use as an outcome measure in clinical practice and research. Scores for each domain range from 0 to 100, with high scores indicating a better health status.

  13. Number of participants with Adverse Events (AEs) [ Time Frame: Up to 100 Weeks ]
  14. Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 100 Weeks ]
  15. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 100 Weeks ]
  16. Number of participants with physical examination abnormalities [ Time Frame: Up to 100 Weeks ]
  17. Number of participants with vital sign abnormalities [ Time Frame: Up to 100 Weeks ]
  18. Number of participants with electrocardiogram (ECG) abnormalities [ Time Frame: Up to 52 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Qualify as having Systemic Lupus Erythematosus (SLE), according to the SLE International Collaborating Clinics (SLICC) Classification Criteria ≥ 12 weeks before 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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04895696


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Show Show 146 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04895696    
Other Study ID Numbers: IM026-024
2019-004021-25 ( EudraCT Number )
U1111-1241-6528 ( Registry Identifier: UTN )
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: November 15, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
BMS-986256
Systemic Lupus Erythematosus
SLE
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Afimetoran
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases