Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon
Search Study Connect
BMS Recruiting Study icon

Recruiting

Trial ID CA061-1001  |   NCT05869955

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

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18+
    Age Range
  • 34
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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).

Nearest Recruiting Site

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Diagnosis of SLE defined as follows:.
    1. Fulfilling the 2019 ACR/EULAR classification criteria of SLE.
      1. Presence of anti-dsDNA, anti-histone, anti-chromatin, or anti-Sm antibodies.
      2. SLE disease activity.
        1. Active disease at screening, defined as ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and/or constitutional organ system).
          1. 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.
            1. Insufficient response is defined as lack of response, insufficient response or lack of sustained response to appropriate doses. Intolerance is not considered insufficient response.
            2. Methotrexate and azathioprine use will count as 1 for the purposes of the number of failed treatments.

        Exclusion Criteria

        Exclusion Criteria Icon
        • Diagnosis of drug-induced SLE rather than idiopathic SLE.
          1. 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.
            1. SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease, are excluded.
              1. Recent or present clinically significant CNS pathology.
                Additional Information *
                • Other protocol-defined Inclusion/Exclusion criteria apply.

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Administration of CC-97540

                  ASSIGNED INTERVENTION
                  • Drug: CC-97540, Cyclophosphamide, Fludarabine
                  Take the first step to see if you Match to a Clinical Trial – Check Your Eligibility
                  Check Your Eligibility
                  Answer some questions about Your health to see if you may match to this trial
                  Match to a Trial
                  If you are a match, click on the study to see the list of study site locations
                  Select a Study Site Location
                  Select a study site location that is convenient for you
                  Register
                  Provide your contact details for the study site to connect with you.

                  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

                  Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

                  Have questions? Live support is available 24/7 -
                  Call 855-907-3286 or email clinical.trials@bms.com