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A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus (ALLEGORY)

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ClinicalTrials.gov Identifier: NCT04963296
Recruitment Status : Recruiting
First Posted : July 15, 2021
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Obinutuzumab Drug: Placebo Drug: Acetaminophen/Paracetamol Drug: Diphenhydramine hydrochloride Drug: Methylprednisolone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 26, 2021
Estimated Primary Completion Date : November 30, 2025
Estimated Study Completion Date : November 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Obinutuzumab
Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1 and at Weeks 2, 24 and 26.
 Drug: Obinutuzumab
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26.
Other Name: Gazyva, GA101, RO5072759

Drug: Acetaminophen/Paracetamol
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.

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

Drug: Methylprednisolone
Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.
Placebo Comparator: Placebo
Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26.
 Drug: Placebo
Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26.

Drug: Acetaminophen/Paracetamol
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.

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

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04963296


Contacts
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Contact: Reference Study ID Number: CA42750 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04963296    
Other Study ID Numbers: CA42750
2020-005760-57 ( EudraCT Number )
2023-504774-38-00 ( Other Identifier: EU CT Number )
First Posted: July 15, 2021    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Acetaminophen
Diphenhydramine
Promethazine
Methylprednisolone
Obinutuzumab
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
 Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents
Antineoplastic Agents, Immunological
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local