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A Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

  • Clinicaltrials.gov identifier

    NCT04895696

  • Recruitment Status

    Not yet recruiting

  • First Posted

    May 20, 2021

  • Last update posted

    May 20, 2021

Study Description

Brief summary:

The purpose of this study is to evaluate the effectiveness, safety and tolerability of BMS-986256 in participants with active SLE.

  • Condition or Disease:Systemic Lupus Erythematosus
  • Intervention/Treatment: Drug: BMS-986256 (Oral)
    Other: Placebo
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • 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 BMS-986256 in Participants With Active Systemic Lupus Erythematosus
  • Estimated Study Start Date: June 2021
  • Estimated Primary Completion Date: May 2024
  • Estimated Study Completion Date: May 2024

Arms and interventions

Arm Intervention/treatment
Experimental: BMS-986256: Dose 1
Drug: BMS-986256 (Oral)
Specified dose on specified days
Experimental: BMS-986256: Dose 2
Drug: BMS-986256 (Oral)
Specified dose on specified days
Experimental: BMS-986256: Dose 3
Drug: BMS-986256 (Oral)
Specified dose on specified days
Placebo Comparator: Placebo
Other: Placebo
Specified dose on specified days

Outcome Measures

  • 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 experience abnormalities or clinically important changes in clinical laboratory values: Chemistry tests [ Time Frame: Up to 52 Weeks ]
  • 2. Number of participants that experience abnormalities or clinically important changes in clinical laboratory values: Coagulation tests [ Time Frame: Up to 52 Weeks ]
  • 3. Proportion of participants that experience abnormalities or clinically important changes in clinical laboratory values: Coagulation tests [ Time Frame: Up to 52 Weeks ]
  • 4. 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 ]
  • 5. Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) at Week 24 and Week 48 [ Time Frame: Up to 48 Weeks ]
  • 6. 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 ]
  • 7. 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 ]
  • 8. 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 ]
  • 9. 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 ]
  • 10. 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 ]
  • 11. 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 ]
  • 12. 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)
  • 13. Proportion of participants who achieve CS reduction or maintenance to ≤ 7.5 mg per day at Week 48 [ Time Frame: Up to 48 Weeks ]
  • 14. Change in patient 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.
  • 15. Number of participants that experience Serious Adverse Events (SAEs) [ Time Frame: Up to 52 Weeks ]
  • 16. Proportion of participants that experience SAEs [ Time Frame: Up to 52 Weeks ]
  • 17. Number of participants that experience Adverse Events (AEs) [ Time Frame: Up to 52 Weeks ]
  • 18. Proportion of participants that experience AEs [ Time Frame: Up to 52 Weeks ]
  • 19. Number of participants that experience abnormalities or clinically important changes in clinical laboratory values: Hematology tests [ Time Frame: Up to 52 Weeks ]
  • 20. Proportion of participants that experience abnormalities or clinically important changes in clinical laboratory values: Hematology tests [ Time Frame: Up to 52 Weeks ]
  • 21. Number of participants that experience abnormalities or clinically important changes in clinical laboratory values: Chemistry tests [ Time Frame: Up to 52 Weeks ]
  • 22. Number of participants that experience abnormalities or clinically important changes in clinical laboratory values: Urinalysis tests [ Time Frame: Up to 52 Weeks ]
  • 23. Proportion of participants that experience abnormalities or clinically important changes in clinical laboratory values: Urinalysis tests [ Time Frame: Up to 52 Weeks ]
  • 24. Number of participants that experience abnormalities or clinically important changes in clinical laboratory values: Serology tests [ Time Frame: Up to 52 Weeks ]
  • 25. Proportion of participants that experience abnormalities or clinically important changes in clinical laboratory values: Serology tests [ Time Frame: Up to 52 Weeks ]
  • 26. Number of participants that experience abnormalities or clinically important changes in physical examination [ Time Frame: Up to 52 Weeks ]
  • 27. Proportion of participants that experience abnormalities or clinically important changes in physical examination [ Time Frame: Up to 52 Weeks ]
  • 28. Number of participants that experience abnormalities or clinically important changes in vital signs: Body temperature [ Time Frame: Up to 52 Weeks ]
  • 29. Proportion of participants that experience abnormalities or clinically important changes in vital signs: Body temperature [ Time Frame: Up to 52 Weeks ]
  • 30. Number of participants that experience abnormalities or clinically important changes in vital signs: Respiratory rate [ Time Frame: Up to 52 Weeks ]
  • 31. Proportion of participants that experience abnormalities or clinically important changes in vital signs: Respiratory rate [ Time Frame: Up to 52 Weeks ]
  • 32. Number of participants that experience abnormalities or clinically important changes in vital signs: Blood pressure [ Time Frame: Up to 52 Weeks ]
  • 33. Proportion of participants that experience abnormalities or clinically important changes in vital signs: Blood pressure [ Time Frame: Up to 52 Weeks ]
  • 34. Number of participants that experience abnormalities or clinically important changes in vital signs: Heart rate [ Time Frame: Up to 52 Weeks ]
  • 35. Proportion of participants that experience abnormalities or clinically important changes in vital signs: Heart rate [ Time Frame: Up to 52 Weeks ]
  • 36. Number of participants that experience abnormalities or clinically important changes in Electrocardiogram (ECG) parameters: PR interval [ Time Frame: Up to 52 Weeks ]
    PR interval is the time from the onset of the P wave to the start of the QRS complex
  • 37. Number of participants that experience abnormalities or clinically important changes in ECG parameters: QRS [ Time Frame: Up to 52 Weeks ]
    QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
  • 38. Number of participants that experience abnormalities or clinically important changes in ECG parameters: QT interval [ Time Frame: Up to 52 Weeks ]
    The QT interval is the time from the start of the Q wave to the end of the T wave
  • 39. Number of participants that experience abnormalities or clinically important changes in ECG parameters: QTcF [ Time Frame: Up to 52 Weeks ]
    QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
  • 40. Proportion of participants that experience abnormalities or clinically important changes in ECG parameters: PR interval [ Time Frame: Up to 52 Weeks ]
  • 41. Proportion of participants that experience abnormalities or clinically important changes in ECG parameters: QRS [ Time Frame: Up to 52 Weeks ]
  • 42. Proportion of participants that experience abnormalities or clinically important changes in ECG parameters: QT interval [ Time Frame: Up to 52 Weeks ]
  • 43. Proportion of participants that experience abnormalities or clinically important changes in ECG parameters: QTcF [ Time Frame: Up to 52 Weeks ]

Eligibility Criteria

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

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com 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 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

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Ohio
Local Institution
Middleburg Heights

Argentina, Buenos Aires
Local Institution
Ciudad Autonoma de Buenos Aires

Argentina, Tucuman
Local Institution
San Miguel de Tucumán

Brazil, Bahia
Local Institution
Salvador

Brazil, Minas Gerais
Local Institution
Juiz de Fora

Brazil, Parana
Local Institution
Curitiba

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, SAO Paulo
Local Institution
São Bernardo do Campo

Brazil, SAO Paulo
Local Institution
São José do Rio Preto

Brazil, SAO Paulo
Local Institution
São Paulo

Chile, Metropolitana
Local Institution
Providencia

Colombia
Local Institution
Barranquilla

Colombia
Local Institution
Cali

Colombia
Local Institution
Chapinero

Colombia
Local Institution
Zipaquira

Mexico, Distrito Federal
Local Institution
Mexico City

Mexico, Guanajuato
Local Institution
Leon

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Nuevo LEON
Local Institution
Monterrey

Mexico, Yucatan
Local Institution
Merida

Mexico
Local Institution
Chihuahua

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04895696 History of Changes
  • Other Study ID Numbers: IM026-024, 2019-004021-25, U1111-1241-6528
  • First Posted: May 20, 2021 Key Record Dates
  • Last Update Posted: May 20, 2021
  • Last Verified: May 2021
  • 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
  • Additional relevant MeSH terms: Lupus Erythematosus, Systemic
    Connective Tissue Diseases
    Autoimmune Diseases
    Immune System Diseases