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Monoclonal Antibodies

Litifilimab for Lupus (TOPAZ-1 Trial)

Phase 3

Recruiting

Research Sponsored by Biogen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be diagnosed with systemic lupus erythematosus (SLE) at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria for SLE at screening by a qualified physician

Participant has BILAG-2004 grade A in ≥ 1 organ system or BILAG-2004 grade B in ≥ 2 organ systems at Screening (adjudicated) and randomization

Must not have

Presence of uncontrolled or New York Heart Association class III or IV congestive heart failure

Use of oral prednisone (or equivalent) above 20 mg/day

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 40 to week 52

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new drug for Lupus called BIIB059. The goal is to see if it is effective in reducing disease activity, and if it has any other benefits compared to placebo. There are many secondary objectives to this study, including assessing the safety and immunogenicity of the drug.

Who is the study for?

Adults diagnosed with systemic lupus erythematosus (SLE) for at least 24 weeks, meeting specific criteria and having active disease despite standard treatments. They must not be on high-dose steroids or have severe kidney issues, uncontrolled heart failure, certain infections like HIV or hepatitis, other skin conditions that could affect assessments, or a history of severe herpes infection.

What is being tested?

The trial is testing the effectiveness and safety of BIIB059 (litifilimab) versus placebo in reducing SLE activity while participants continue their usual lupus medications. It aims to show benefits in overall disease control, organ-specific outcomes like joint and skin health, reduced need for steroids, and improved quality of life.

What are the potential side effects?

While the side effects are not detailed here, litifilimab may cause reactions similar to other immune-modulating drugs such as infusion-related reactions, increased risk of infections due to immune system suppression, potential liver enzyme changes, and possible impact on blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with lupus more than 24 weeks ago and meet the 2019 lupus criteria.

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My lupus affects at least one organ severely or two organs moderately.

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My lupus activity score is 6 or more, not counting hair loss, fever, headaches, or brain symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe heart failure that is not under control.

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I am taking more than 20 mg/day of oral prednisone or its equivalent.

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I have active brain-related symptoms due to lupus.

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I have or had a significant blood vessel inflammation not related to lupus.

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I am currently infected with hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 40 to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 40 to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 40 to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52

Secondary study objectives

Annualized Flare Rate Through Week 52

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score

Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score

+20 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Litifilimab Low DoseExperimental Treatment1 Intervention

Participants who are receiving background nonbiologic lupus SOC therapy will receive low dose of litifilimab, SC Q4W, up to Week 48 with an additional dose at Week 2.

Group II: Litifilimab High DoseExperimental Treatment1 Intervention

Participants who are receiving background nonbiologic lupus SOC therapy will receive high dose of litifilimab, subcutaneously (SC) every 4 weeks (Q4W), up to Week 48 with an additional dose at Week 2.

Group III: PlaceboPlacebo Group1 Intervention

Participants who are receiving background nonbiologic lupus SOC therapy will receive litifilimab-matching placebo, SC Q4W, up to Week 48 with an additional dose at Week 2.

0 / 8Eligibility criteria met