What side effects are associated with this type of intervention?

Common treatments for systemic lupus erythematosus (SLE) include corticosteroids, antimalarials, immunosuppressants, and biologics. Corticosteroids can cause weight gain, hypertension, and increased risk of infections. Antimalarials like hydroxychloroquine may lead to gastrointestinal upset and retinal toxicity. Immunosuppressants such as methotrexate and mycophenolate mofetil can result in bone marrow suppression and liver toxicity. Biologics, including monoclonal antibodies targeting specific cytokines, may cause infusion reactions, increased risk of infections, and potential malignancies. For selective TYK2 inhibitors like BMS-986165, long-term safety data is still being gathered, but potential side effects could include infections, gastrointestinal issues, and liver enzyme abnormalities.

What prior FDA approvals exist?

The FDA has approved several treatments for systemic lupus erythematosus (SLE), including biologics and targeted therapies. Belimumab (Benlysta) was the first biologic approved for SLE, targeting the B-lymphocyte stimulator (BLyS). More recently, anifrolumab (Saphnelo), an anti-interferon-alpha receptor monoclonal antibody, was approved for SLE. These treatments, like BMS-986165, aim to modulate the immune system to reduce disease activity. While BMS-986165 is a selective TYK2 inhibitor, it represents a novel approach compared to the existing biologics by targeting specific intracellular signaling pathways involved in the immune response.

What other types of research exist?

Promising novel alternatives to BMS-986165 for Lupus patients include Anifrolumab, a monoclonal antibody targeting the type I interferon receptor, and Voclosporin, a calcineurin inhibitor. Both have shown efficacy in recent clinical trials and are considered potential treatments for systemic lupus erythematosus.

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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Lupus

Phase 2

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Evidence of active tuberculosis (TB)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medication called BMS-986165 to see if it is safe and can be tolerated by people with Systemic Lupus Erythematosus (SLE).

Who is the study for?

This trial is for people who have completed a previous SLE study (NCT03252587) and are currently on the blinded study drug. Exceptions may be made for those who missed doses due to special circumstances like COVID-19, with approval from the trial physician.

What is being tested?

The focus of this study is on BMS-986165's long-term safety and effectiveness in treating Systemic Lupus Erythematosus. Participants will continue using this medication over an extended period to monitor its ongoing impact.

What are the potential side effects?

While specific side effects aren't listed here, they typically include reactions related to immune system changes, potential organ inflammation, or issues caused by long-term medication use. The exact side effects will be closely monitored throughout the trial.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have active tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 3 trial • 220 Patients • NCT04167462

18%

Upper respiratory tract infection

Mouth ulceration

Nasopharyngitis

Pruritus

Headache

Folliculitis

Psoriasis

Cholecystitis

Pharyngitis

Gastroenteritis

Gastroenteritis shigella

Diabetes mellitus

Accidental overdose

Hepatobiliary procedural complication

Psoriatic arthropathy

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Week 0 up to Week 16

BMS-986165 Week 0 up to Week 52

BMS-986165 Week 16 up to Week 52

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: BMS-986165 Dose 3Experimental Treatment1 Intervention

Group II: BMS-986165 Dose 2Experimental Treatment1 Intervention

Group III: BMS-986165 Dose 1Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-986165

2020

Completed Phase 3

~2990

0 / 1Eligibility 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

BMS-986165 is a selective TYK2 inhibitor that targets intracellular signaling pathways involved in the inflammatory response, specifically by inhibiting the JAK-STAT pathway. This is crucial for Lupus patients as it helps reduce the overactive immune response that characterizes the disease. Other common treatments for Lupus include immunosuppressants like mycophenolate mofetil, which inhibits lymphocyte proliferation, and biologics like belimumab, which targets B-cell activating factor (BAFF) to reduce B-cell activity. Understanding these mechanisms is important for Lupus patients because it helps tailor treatments to their specific immune dysregulation, potentially improving efficacy and reducing side effects.

Mechanistic Paradigms of Natural Plant Metabolites as Remedial Candidates for Systemic Lupus Erythromatosus.The 2018 pipeline of targeted therapies under clinical development for Systemic Lupus Erythematosus: a systematic review of trials.Treat-to-target in systemic lupus erythematosus: recommendations from an international task force.