A Study of CC-97540 in Participants With Severe, Refractory Systemic Lupus Erythematosus (SLE)
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Administration of CC-97540
|
Drug: CC-97540
Specified dose on specified days
Other Names:
Drug: Fludarabine
Specified dose on specified days
Drug: Cyclophosphamide
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- Number of participants with treatment-emergent adverse events (AEs) [Up to 2 years after CC-97540 infusion]
- Number of participants with serious AEs (SAEs) [Up to 2 years after CC-97540 infusion]
- Number of participants with AEs of special interest (AESI) [Up to 2 years after CC-97540 infusion]
- Number of participants with laboratory abnormalities [Up to 2 years after CC-97540 infusion]
- Number of participants with Dose Limiting Toxicities (DLT) [Up to 2 years after CC-97540 infusion]
- Recommend Phase 2 Dose (RP2D) of CC-97540 [Up to 2 years after CC-97540 infusion]
Secondary Outcome Measures
- Proportion of participants achieving definition of remission in SLE (DORIS) remission [At week 24]
- Proportion of participants achieving Lupus Low Disease Activity State (LLDAS) [At week 24]
- Change in proteinuria measured by urine protein creatinine ratio (UPCR) [At week 24]
- Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) [At week 24]
- Proportion of participants achieving DORIS remission over time [Up to 2 years]
- Proportion of participants achieving LLDAS over time [Up to 2 years]
- Change in Systemic Lupus Erythematosus Disease Activity- 2000 (SLEDAI-2K) over time [Up to 2 years]
- Change in proteinuria measured by UPCR over time [Up to 2 years]
- Time to the first documentation of DORIS remission [Up to 2 years]
- Time to the first documentation of LLDAS [Up to 2 years]
- Time from CC-97540 infusion to first disease flare, any flare monitoring by Safety of Estrogens in Lupus Erythematosus National Assessment-SLEDAI (SELENA-SLEDAI) [Up to 2 years]
- Maximum observed blood concentration (Cmax) [Up to 2 years]
- Time of maximum observed blood concentration (Tmax) [Up to 2 years]
- Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D)) [Up to 2 years]
Eligibility Criteria
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)
-
- 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.
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution - 0025 | Berlin | Germany | 10117 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
- BMS Clinical Trial Information
Publications
None provided.- CA061-1001
- 2023-503823-24