Overview

A Study of CC-97540 in Participants With Severe, Refractory Systemic Lupus Erythematosus (SLE)

Status:
Not yet recruiting
Trial end date:
2028-02-21
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory Systemic Lupus Erythematosus (SLE).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Cyclophosphamide
Fludarabine
Criteria
Inclusion Criteria:

- Diagnosis of SLE defined as follows:

- Fulfilling the 2019 ACR/EULAR classification criteria of SLE

- Presence of anti-dsDNA, anti-histone, anti-chromatin, or anti-Sm antibodies

- SLE disease activity

- Active disease at screening, defined as ≥ 1 major organ system with a BILAG A
score (excluding musculoskeletal, mucocutaneous, and/or constitutional organ
system)

- ii) Inadequate response to glucocorticoids and to at least 2 of the following
treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid
or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate,
rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin.

i) Insufficient response is defined as lack of response, insufficient response or
lack of sustained response to appropriate doses. Intolerance is not considered
insufficient response ii) Methotrexate and azathioprine use will count as 1 for
the purposes of the number of failed treatments.

Exclusion Criteria:

- Diagnosis of drug-induced SLE rather than idiopathic SLE

- Other systemic autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory
bowel disease, etc) are excluded. Participants with type I autoimmune diabetes
mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome
are not excluded

- SLE overlap syndromes including, but not limited to, rheumatoid arthritis,
scleroderma, and mixed connective tissue disease, are excluded

- Recent or present clinically significant CNS pathology

Other protocol-defined Inclusion/Exclusion criteria apply.