M32 Systemic lupus erythematosus Systemic lupus erythematosus
Conditions
Interventions
There will be approximately 245 participants randomized into the deucravacitinib. Blinding will be maintained throughout the 52- week treatment period of the study. Participants will receive deucravac
Sponsors
Bristol Myers Squibb Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Individual participants 18 to 75 years of age. • Must have been diagnosed with SLE at least 24 weeks prior to screening. • Meet the European Alliance of Associations for Rheumatology/American College of Rheumatology 2019 classification criteria for SLE at screening. • Test positive for at least 1 of the following lupus-related autoantibodies at the time of screening: antinuclear antibody (ANA) = 1:80, anti-dsDNA antibody, or anti-Smith antibody (anti-Sm), as determined by the central laboratory. • Have a total SLEDAI-2K score = 6 points, and clinical SLEDAI-2K score = 4 points and must include joint involvement, and/or cutaneous vasculitis, and/or rash (SLEDAI score will undergo review by the RRG). o Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI-2K, if indicated, but do not count toward the points required for screening at entry. o Clinical SLEDAI-2K excludes laboratory abnormalities such as hematuria, pyuria, urinary casts, proteinuria, positive anti-dsDNA, decreased complement, thrombocytopenia, and leukopenia. Inclusion Criteria for the Optional Long-term Extension Period Only 1) Signed Written Informed Consent: Must be willing to participate in the LTE period and must be willing and able to sign the informed consent form (ICF). 2) Type of Participants and Target Disease Characteristics Completion of the protocol-required double-blind treatment period and receiving blinded study drug. Note: If a participant is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational [medicinal] product [IP/IMP] due to COVID-19 pandemic), the participant may be allowed to enroll with approval from the Medical Monitor.
Exclusion criteria
Exclusion criteria: • Medical conditions o Conditions that may complicate SLE diagnosis or assessment of disease activity. o Life- or organ-threatening SLE manifestations • Medical conditions and history o Medical conditions that may place participant at higher risk for taking an investigational therapy. • Prior and concomitant therapy o Exposure to prohibited immunomodulatory drugs or biologic drugs. o Taking more than 1 immunosuppressant at screening. o Oral corticosteroids (prednisone or equivalent) = 30 mg per day. o Prior exposure to TYK2 inhibitors. • Infection and/or immune-related exclusions o Infections or immune-related conditions that may place participant at higher risk when taking an immunomodulating agent. • Physical and laboratory test findings o Clinically significant abnormalities on chest x-ray or ECG. o Clinically significant abnormalities in laboratory tests, including the following: ? Serum alanine aminotransferase (ALT) > 2× ULN, unless confirmed due to SLE activity and confirmed not due to any other etiology. Exclusion Criteria for the Optional Long-term Extension Period Only 1) Medical History and Concurrent Diseases a) Any disease or medical condition that, in the opinion of the investigator, would make the participant unsuitable for this study, would interfere with the interpretation of participant’s safety or study results, or considered unsuitable by the investigator for any other reason. 2) Findings Related to Possible TB Infection a) Evidence of active TB, as judged by the investigator, or evidence of LTBI (as indicated by positive IGRA or indeterminate IGRA in the absence of guidance from local expert stating treatment is not necessary) in participant unwilling to undergo prophylactic treatment (see Section 9.4.4: Tuberculosis Screening and Chest X-ray). Note: All participants will undergo complete physical examination and medical history to evaluate exposure to TB, and all participants will complete TB questionnaire annually. If participants are at increased risk based on TB questionnaire, they must undergo IGRA with further assessment/treatment outlined in Section 9.4.4: Tuberculosis Screening and Chest X-ray. All participants with positive or indeterminate IGRA should be discussed with the Medical Monitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who achieve SRI(4)a response at Week 52, defined by the following criteria: ? Reduction from Baseline of = 4 points in the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score, and ? No new BILAG A scores or not more than 1 new BILAG B organ domain score, and ? No worsening in PGA (< 0.3-point increase from baseline) using a visual analog scale (VAS), with anchor scores ranging from 0-3. NAME OF THE RESULT: To demonstrate superiority of deucravacitinib compared to PBO in treatment of participants with SLE with respect to SRI(4). PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidences of AEs, SAEs, AEs leading to discontinuation of treatment and study discontinuation, and target AESIs; change from baseline in laboratory, ECG, and vital signs; and abnormalities in laboratory, ECG, and vital signs. Proportion of participants in SRI(4), SRI(6), and SRI(8) response at Week 104, Week 156 and by visit. • Proportion of participants who achieve SRI(4) and SRI(6) response at Week 52 who maintain SRI(4) and SRI(6), response respectively at Week 104, and Week 156 (and = 70% of visits between). • Proportion of participants in BICLA response at Week 104, Week 156, and by visit. . • Proportion of participants in BICLA response at Week 52 who maintain BICLA response at Week 104 and Week 156 (and = 70% of visits between). • Proportion of participants who achieve both SRI(4) and BICLA (dual responders) at Week 104, Week 156 and by visit. • Proportion of participants who achieve LLDAS at Week 104, Week 156, and by visit. • Proportion of participants with a CLASI activity score = 10 at baseline who achieve a CLASI response, defined as a decrease of = 50% from baseline CLASI activity score at Week 104, Week 156, and by visit. • Proportion of participants with = 6 active (tender + swollen) joints at baseline who achieve a 50% Incidences of AEs, SAEs, AEs leading to discontinuation of treatment and study discontinuation, and target AESIs; change from baseline in laboratory, ECG, and vital signs; and abnormalities in laboratory, ECG, and vital signs. Proportion of participants in SRI(4), SRI(6), and SRI(8) response at Week 104, Week 156 and by visit. • Proportion of participants who achieve SRI(4) and SRI(6) response at Week 52 who maintain SRI(4) and SRI(6), response respectively at Week 104, and Week 156 (and = 70% of visits between). • Proportion of participants in BICLA response at Week 104, Week 156, and by visit. . • Proportion of participants in BICLA response at Week 52 who maintain BICLA response at Week 104 and Week 156 (and = 70% of visits between | — |
Countries
Argentina, Brazil, Bulgaria, Canada, China, Colombia, France, Germany, Hong Kong, Ireland, Italy, Mexico, Peru, Poland, Romania, Turkey, United States
Contacts
Public ContactYsel Janett Hun
BRISTOL-MYERS SQUIBB PERU S.A.
Outcome results
None listed