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A Study of CC-97540 in Participants With Severe, Refractory Systemic Lupus Erythematosus (SLE) - CA061-1001

Updated: 29 November, 2023   |

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1


  • Gender(s)

  • 18+

    Age Range

  • 25


  • Recruiting

Treatment Options

Study Arms
Experimental: Administration of CC-97540
Drug: CC-97540 Drug: Cyclophosphamide Drug: Fludarabine

Key Eligibility 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.

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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