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A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with Systemic Lupus Erythematosus (ALLEGORY)
EU CTIS ID: 2023-504774-38-00
What this study is testing
To evaluate the efficacy of obinutuzumab compared with placebo based on proportion of participants who achieve systemic lupus erythematosus responder index (SRI) (4)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria ≥12 weeks prior to screening
- 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
- Low C3 or low C4 or low CH50 complement as determined by the central laboratory at screening Low C3 is required in the presence of known genetic deficiency of C4
- High disease activity at screening, based on; British Isles Lupus Assessment Group (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])
- High disease activity on Day 1, based on; SLEDAI-2K (score ≥8) and PGA (score ≥1.0 on a 0 to 3 VAS)
- 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
You likely can't join if
- Pregnancy or breastfeeding
- Presence of significant lupus-associated renal disease and/or renal impairment
- 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
- Significant or uncontrolled medical disease which, in the investigator’s opinion, would preclude patient participation
- Known active infection of any kind or recent major episode of infection
- Intolerance or contraindication to study therapies
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Mexico
- Peru
- United States
- South Africa
- Russian Federation
- United Kingdom
- Argentina
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Mexico; Peru; United States; South Africa; Russian Federation and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.