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NCT Number: NCT04963296

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

DOM Centro de Reumatología, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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])
  • 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
  • Other inclusion criteria may apply
  • The Medical Monitor may be consulted if there are any questions related to eligibility criteria

Exclusion criteria

  • 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
  • Other exclusion criteria may apply

Treatment and study plan

Obinutuzumab

Drug

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

Drug

Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26.

Acetaminophen/paracetamol

Drug

Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.

Diphenhydramine hydrochloride

Drug

Diphenhydramine 50 mg will be administered as premedication prior to infusions.

methylprednisolone

Drug

Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.

Primary outcomes

  1. Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index (SRI[4]) at Week 52

    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).

Secondary outcomes

  1. Percentage of Participants who Achieve SRI(6) at Week 52

    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.

  2. Percentage of Participants Entering the Study on Prednisone >= 10 mg/day (or equivalent) who Achieve Sustained Corticosteroid Control

    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.

  3. Time to First BILAG Flare over 52 Weeks

    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

  4. Percentage of Participants who Achieve a Sustained SRI(4) Response

    Time frame: From Week 40 to Week 52

    Achievement of SRI(4) at all study visits from Week 40 through Week 52.

  5. Percentage of Participants who Achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at 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.

  6. Percentage of Participants who Achieve SRI(8) at Week 52

    Time frame: Week 52

  7. Percentage of Participants who Achieve SRI(4) at Week 24

    Time frame: Week 24

  8. Percentage of Participants who Achieve Clinical SRI(4) at Week 52

    Time frame: Week 52

  9. Percentage of Participants who Achieve SRI(4) at Week 52 on Low-dose Corticosteroids

    Time frame: Week 52

  10. Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS) at Week 52

    Time frame: Week 52

  11. Percentage of Participants who Achieve Definition of Remission in SLE (DORIS) at Week 52

    Time frame: Week 52

  12. Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale

    Time frame: From baseline to Week 24 and from baseline to Week 52

  13. Change in 36-Item Short Form Survey, Version 2 (SF-36 v2) Bodily Pain Domain Scale

    Time frame: From baseline to Week 24 and from baseline to Week 52

  14. Change in SF-36 v2 Physical Component Summary Scale

    Time frame: From baseline to Week 24 and from baseline to Week 52

  15. Change in Active Joint Count (Swollen plus Tender)

    Time frame: From baseline to Week 24 and from baseline to Week 52

  16. Percentage of Participants who Achieve a >= 50% Reduction in Active Joint Counts (Swollen plus Tender) at Each Study Visit

    Time frame: From baseline to Week 52

  17. Percentage of Participants who Achieve a >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity (CLASI) Total Activity Score at each Study Visit, among Participants with CLASI Total Activity Score >=10 at Baseline

    Time frame: From baseline to Week 52

  18. Percentage of Participants who Achieve Sustained Corticosteroid Control

    Time frame: From Week 40 through Week 52

  19. Cumulative Corticosteroid use (in Equivalent Milligrams of Prednisone)

    Time frame: From baseline to Week 52

  20. Annualized flare rate through Week 52

    Time frame: At Week 52

  21. Percentage of Participants with Adverse Events

    Time frame: From baseline to approximately 6 years

  22. Percentage of Participants with Adverse Events of Special Interest (AESIs)

    Time frame: From baseline to approximately 6 years

  23. Serum Concentration of Obinutuzumab

    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

  24. Percentage of Participants with Anti-drug Antibodies (ADAs) at Baseline

    Time frame: Baseline

  25. Percentage of Participants with ADAs During the Study

    Time frame: Up to approximately 6 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2028
First posted
Jul 15, 2021
Registry last updated
May 14, 2026

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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