The trial is taking place at:
P

Prolato Clinical Research Center | Houston, TX

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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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Roche

Status and phase

Enrolling
Phase 3

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: Methylprednisolone
Drug: Acetaminophen/Paracetamol
Drug: Placebo
Drug: Diphenhydramine hydrochloride
Drug: Obinutuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04963296
2020-005760-57 (EudraCT Number)
CA42750
2023-504774-38-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

300 participants in 2 patient groups, including a placebo group

Obinutuzumab
Experimental group
Description:
Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1 and at Weeks 2, 24 and 26.
Treatment:
Drug: Obinutuzumab
Drug: Diphenhydramine hydrochloride
Drug: Acetaminophen/Paracetamol
Drug: Methylprednisolone
Placebo
Placebo Comparator group
Description:
Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26.
Treatment:
Drug: Diphenhydramine hydrochloride
Drug: Placebo
Drug: Acetaminophen/Paracetamol
Drug: Methylprednisolone

Trial contacts and locations

104

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Central trial contact

Reference Study ID Number: CA42750 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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