Obinutuzumab for Lupus

(ALLEGORY Trial)

Recruiting at 131 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called obinutuzumab in people with active lupus who have specific antibodies in their blood. These patients are already on standard treatments but need more help. The medication works by reducing harmful immune cells that cause inflammation and damage.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for people with active, autoantibody-positive systemic lupus erythematosus (SLE) who have high disease activity despite standard treatments. Participants must meet specific criteria including low complement levels and positive ANA or anti-dsDNA/anti-Sm antibodies. They should not have severe kidney issues related to lupus, be pregnant or breastfeeding, or have used certain excluded therapies recently.

Inclusion Criteria

My lupus is highly active, with a SLEDAI score of 8 or more and a PGA score of 1 or more.

I am currently taking medication for lupus at a stable dose.

The Medical Monitor may be consulted if there are any questions related to eligibility criteria

Exclusion Criteria

I haven't taken specific immune therapies or certain medications in the months before my screening.

Pregnancy or breastfeeding

Other exclusion criteria may apply

Treatment Details

Interventions

• Obinutuzumab (Monoclonal Antibodies)

Trial Overview The study tests the effectiveness and safety of Obinutuzumab compared to a placebo in SLE patients on standard care. It's a parallel-group, double-blind trial meaning neither participants nor researchers know who gets the real drug versus placebo during the study.

Participant Groups

Group I: Obinutuzumab Experimental Treatment 4 Interventions

Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1 and at Weeks 2, 24 and 26.

Group II: Placebo Placebo Group 4 Interventions

Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University