A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.
This phase III, double-blind study will have two arms: Experimental-Participants will receive obinutuzumab 1000 mg IV infusions on Day 1 and at Weeks 2, 24 and 26; Placebo Comparator-Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26. The trial will last for 52 weeks. Adults aged 18 years to 75 years are eligible.More
Participants should be at least 18 years old with a diagnosis of SLE for at least 12 weeks prior to screening. They should be a current receipt of at least one of the standard therapies for SLE at stable doses: oral corticosteroid, antimalarials, conventional immunosuppressants.
Inclusion Criteria: 1. Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria >=12 weeks prior to screening 2. Anti-nuclear antibody (ANA) >=1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening 3. Low C3 and/or low C4 and/or low CH50 complement as determined by the central laboratory at screening 4. High disease activity at screening, based on; BILAG-2004 (Category A disease in >=1 organ system and/or Category B disease in >=2 organ systems), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (score >=8) and Physician's Global Assessment (PGA) (score >=1.0 on a 0 to 3 visual analogue scale [VAS]) 5. High disease activity on Day 1, based on; SLEDAI-2K (score >=8) and PGA (score >=1.0 on a 0 to 3 VAS) 6. Current receipt of >=1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants 7. Other inclusion criteria may apply Exclusion Criteria: 1. Pregnancy or breastfeeding 2. Presence of significant lupus-associated renal disease and/or renal impairment 3. Receipt of an excluded therapy, including any anti-CD20, anti-CD19 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening 4. Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation 5. Known active infection of any kind or recent major episode of infection 6. Intolerance or contraindication to study therapies 7. Other exclusion criteria may apply
Barbara Davis Center
University of Colorado Hospital
Christopher Striebich, MD, PhD
Protocol Number: 21-3268
More information available at ClinicalTrials.gov: NCT04963296
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