Obinutuzumab
DrugObinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26.
Other names: Gazyva, GA101, RO5072759
NCT Number: NCT04963296
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 study is active but is not currently recruiting participants.
Notify Me18 year–75 year
All sexes
Interventional
Phase 3
DOM Centro de Reumatología, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26.
Other names: Gazyva, GA101, RO5072759
Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26.
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.
Time frame: Week 52
SRI(4) requires reduction from baseline of >=4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), no new systems or organs affected, as defined by >=1 new British Isles Lupus Assessment Group (BILAG) A or >=2 new BILAG B items compared with baseline using BILAG-2004, and no worsening from baseline of >=0.30 points on a 3-point Physician's Global Assessment Visual Analogue Scale (PGA-VAS).
Time frame: Week 52
SRI(6) requires reduction from baseline of >=6 points in the SLEDAI-2K, no new systems or organs affected, as defined by >=1 new BILAG A or >=2 new BILAG B items compared with baseline using BILAG-2004, and no worsening from baseline of >=0.30 points on a 3-point PGA-VAS.
Time frame: From Week 40 to Week 52
No treatment with prednisone >=7.5 mg/day (or equivalent) and no receipt of intravenous, intramuscular, or intra-articular corticosteroids.
Time frame: From baseline to Week 52
Flare is defined as the occurrence of >=1 new BILAG A or >=2 new BILAG B manifestations from the previous visit
Time frame: From Week 40 to Week 52
Achievement of SRI(4) at all study visits from Week 40 through Week 52.
Time frame: Week 52
Reduction of all baseline BILAG-2004 A items to B/C/D and baseline BILAG-2004 B items to C/D; no new systems or organs affected, as defined by >=1 new BILAG A or >=2 new BILAG B items compared with baseline; no net increase in SLEDAI-2K score from baseline; and no worsening from baseline of >=0.30 points on a 3-point PGA-VAS.
Time frame: Week 52
Time frame: Week 24
Time frame: Week 52
Time frame: Week 52
Time frame: Week 52
Time frame: Week 52
Time frame: From baseline to Week 24 and from baseline to Week 52
Time frame: From baseline to Week 24 and from baseline to Week 52
Time frame: From baseline to Week 24 and from baseline to Week 52
Time frame: From baseline to Week 24 and from baseline to Week 52
Time frame: From baseline to Week 52
Time frame: From baseline to Week 52
Time frame: From Week 40 through Week 52
Time frame: From baseline to Week 52
Time frame: At Week 52
Time frame: From baseline to approximately 6 years
Time frame: From baseline to approximately 6 years
Time frame: Double blind period: At Weeks 2, 4, 12, 24, 26, 36, 52 and at early study discontinuation visit; Open label period: At Weeks 54, 56, 58, 66, 78, 90, 104 and at early study discontinuation visit
Time frame: Baseline
Time frame: Up to approximately 6 years
Hoffmann-La Roche
Industry
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus
Acronym: ALLEGORY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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