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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 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
8%
Mouth ulceration
7%
Nasopharyngitis
5%
Pruritus
5%
Headache
3%
Folliculitis
3%
Psoriasis
1%
Pharyngitis
1%
Cholecystitis
1%
Gastroenteritis
1%
Gastroenteritis shigella
1%
Diabetes mellitus
1%
Accidental overdose
1%
Hepatobiliary procedural complication
1%
Psoriatic arthropathy
100%
80%
60%
40%
20%
0%
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

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.

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,688 Previous Clinical Trials
4,096,546 Total Patients Enrolled
5 Trials studying Lupus
1,111 Patients Enrolled for Lupus

Media Library

BMS-986165 (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03920267 — Phase 2
Lupus Research Study Groups: BMS-986165 Dose 1, BMS-986165 Dose 2, BMS-986165 Dose 3
Lupus Clinical Trial 2023: BMS-986165 Highlights & Side Effects. Trial Name: NCT03920267 — Phase 2
BMS-986165 (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03920267 — Phase 2
~11 spots leftby Mar 2025