What side effects are associated with this type of intervention?

Common treatments for Lupus that modulate the interferon pathway include monoclonal antibodies like anifrolumab and other immunosuppressive agents. Known side effects of these treatments often include headache, nausea, and diarrhea. More severe adverse events can include increased risk of infections, infusion reactions, and potential liver toxicity. It is important for patients to discuss these risks with their healthcare provider to manage and monitor any side effects effectively.

What prior FDA approvals exist?

Belimumab is the only FDA-approved treatment for systemic lupus erythematosus (SLE) in the past 60 years. It has demonstrated significant efficacy and a reassuring safety profile. Belimumab works by inhibiting the activity of B-lymphocyte stimulator (BLyS), which is involved in the autoimmune response in lupus. While not directly targeting the interferon pathway like Afimetoran, it represents a biologic approach to modulating the immune system in SLE treatment.

What other types of research exist?

Promising novel alternatives to Afimetoran for Lupus patients include biologics such as Anifrolumab, a monoclonal antibody targeting the type I interferon receptor, and Belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS). Both have shown efficacy in reducing disease activity in systemic lupus erythematosus (SLE) patients.

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Unknown

Afimetoran for Lupus

Phase 2

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

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

Must have

Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody ≥ 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody

Be older than 18 years old

Must not have

Antiphospholipid Syndrome

Timeline

Screening 14 days

Treatment Varies

Follow Up 3 days

Awards & highlights

Summary

This trial is testing a new medication called Afimetoran to help people with active Systemic Lupus Erythematosus (SLE). The goal is to see if it can safely reduce symptoms by calming down the immune system. The study will also provide data on its effectiveness and safety over time.

Who is the study for?

This trial is for people with active Systemic Lupus Erythematosus (SLE) who meet specific criteria, including a positive test for certain lupus-related antibodies and a minimum disease activity score. It's not open to those with severe lupus nephritis, Antiphospholipid Syndrome, unstable neuropsychiatric symptoms, or if their main diagnosis isn't SLE.

What is being tested?

The study tests the effectiveness and safety of Afimetoran versus a placebo in individuals with active SLE. Participants will be randomly assigned to receive either Afimetoran or a placebo to compare outcomes and gather long-term data on Afimetoran's performance.

What are the potential side effects?

While the specific side effects of Afimetoran are not listed here, common side effects in trials like this may include nausea, headache, fatigue, possible allergic reactions or flare-ups of SLE symptoms. Safety and tolerability are key focuses of this study.

Eligibility Criteria

Inclusion Criteria

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

Select...

I tested positive for lupus-related antibodies.

Exclusion Criteria

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

Select...

I have been diagnosed with Antiphospholipid Syndrome.

Timeline

Screening ~ 14 days5 visits

Treatment ~ Varies

Follow Up ~ 3 days3 visits

Screening ~ 14 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 14 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change from baseline in PGA score of disease activity at Week 24 and Week 48

Change in participant reported disease activity from baseline to Week 24 and Week 48 according to the 36-item Short Form Health Questionnaire (SF-36)

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Afimetoran: Dose 3Experimental Treatment1 Intervention

Group II: Afimetoran: Dose 2Experimental Treatment1 Intervention

Group III: Afimetoran: Dose 1Experimental Treatment1 Intervention

Group IV: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Afimetoran

2023

Completed Phase 1

~70

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lupus, such as hydroxychloroquine, work by modulating the immune system to reduce inflammation and autoantibody production. Hydroxychloroquine interferes with the communication between cells in the immune system, thereby reducing the activity of lupus. Corticosteroids and immunosuppressive agents like methotrexate and mycophenolate mofetil suppress the overall immune response to prevent tissue damage. Afimetoran, a selective modulator of the interferon pathway, targets specific components of the immune system involved in lupus pathogenesis, potentially offering a more targeted approach with fewer side effects. Understanding these mechanisms is crucial for lupus patients as it helps them comprehend how these treatments can control their disease and improve their quality of life.

Support for phosphoinositol 3 kinase and mTOR inhibitors as treatment for lupus using in-silico drug-repurposing analysis.