The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
Diagnosis of Idiopathic Inflammatory Myopathy (IIM) defined as follows:.
IIM disease activity:.
Diagnosis of Systemic Sclerosis (SSc) defined as follows:.
SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease, are excluded.
Present or recent clinically significant CNS pathology, within 12 months.
IIM disease activity:.
Single group
CC-97540
DrugSpecified dose on specified days
Fludarabine
DrugSpecified dose on specified days
Cyclophosphamide
DrugSpecified dose on specified days
Tocilizumab
DrugSpecified dose on specified days
Number of participants with treatment-emergent adverse events (AEs) in each indication.
Number of participants with serious AEs (SAEs) in each indication.
Number of participants with AEs of special interest (AESI) in each indication.
Number of participants with laboratory abnormalities in each indication.
Proportion of participants achieving definition of remission in SLE (DORIS) remission
SLE Cohort
Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)
SLE Cohort
Change in proteinuria measured by urine protein creatinine ratio (UPCR)
SLE Cohort
Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)
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Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Lead sponsor
Bristol-Myers Squibb Services Unlimited Company
Collaborator
