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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
Treatment Details
Side effects data
From 2022 Phase 3 trial • 220 Patients • NCT0416746218%
Upper respiratory tract infection
8%
Mouth ulceration
7%
Nasopharyngitis
5%
Pruritus
5%
Headache
3%
Folliculitis
3%
Psoriasis
1%
Pharyngitis
1%
Gastroenteritis
1%
Cholecystitis
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.
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
2,696 Previous Clinical Trials
4,098,810 Total Patients Enrolled
5 Trials studying Lupus
1,111 Patients Enrolled for Lupus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- There are other requirements or restrictions for participating in the study that are defined in the study's protocol.I have active tuberculosis.
Research Study Groups:
This trial has the following groups:- Group 1: BMS-986165 Dose 1
- Group 2: BMS-986165 Dose 2
- Group 3: BMS-986165 Dose 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.