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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after last treatment dose (approximately 178 weeks)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for people with lupus.

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after last treatment dose (approximately 178 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after last treatment dose (approximately 178 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with AEs leading to discontinuation
Number of participants with Adverse Events (AEs)
Number of participants with Serious Adverse Events (SAEs)
+2 more

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%
Cholecystitis
1%
Gastroenteritis shigella
1%
Gastroenteritis
1%
Pharyngitis
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

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

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,253 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do participants aged 55 or older meet the criteria for this medical experiment?

"Patients over 18 years of age and under 75 may submit an application to be a part of this research."

Answered by AI

Has a similar study been undertaken in the past?

"To date, 11 clinical trials of BMS-986165 have been run in 401 cities and 36 countries since its inception in 2018. Sponsored by Bristol-Myers Squibb, the initial Phase 2 drug approval study comprised 240 patients with 34 further studies conducted since then."

Answered by AI

Is the clinical trial for this new treatment protocol being conducted widely across the US?

"Patients can join this trial at Local Institution - 0131 in New york, Arthritis & Rheumatic Disease Specialties in Aventura, and Local Institution - 0064 in Oklahoma City alongside an additional 41 medical sites."

Answered by AI

What is the current participant count for this research endeavor?

"At present, this trial is not accepting new candidates. It was first announced on March 26th 2019 and last updated on October 4th 2022. However, there are currently 122 trials with lupus erythematosus systemic open for recruiting as well 11 studies that require participants to take BMS-986165."

Answered by AI

Do I meet the qualifications to partake in this medical experiment?

"This study is seeking 261 participants aged 18–75 with lupus erythematosus, systemic. Additional inclusion criteria include having completed the SLE Study (NCT03252587) and being currently administered a blind trial drug. Exceptions may be granted by the BMS Clinical Trial Physician or designee if unable to receive blinded medication due to extenuating circumstances like delays in approval caused by COVID-19."

Answered by AI

Has BMS-986165 been subjected to other experimental trials?

"BMS-986165 saw its initial testing in 2018 at H-T. Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia and has since gone on to complete 34 clinical trials. Currently, 11 of these investigations are actively recruiting participants with a majority of them being based out of New york City."

Answered by AI

What is the status of regulatory approval for BMS-986165?

"Our team at Power assessed the safety of BMS-986165 as a 2 due to its Phase 2 status, which suggests some clinical evidence for safety but no proof of efficacy."

Answered by AI

Are there any vacancies available in this clinical trial?

"Data acquired from clinicaltrials.gov states that this medical research project is no longer recruiting patients, having been initially posted on March 26 2019 and last updated October 4 2022. Nonetheless, there are 133 other trials presently looking for participants."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
The Emory Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've tried several different things especially the CPAP apnea machine not working for me.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long does screen take, what all is needed to complete, what all is needed from me, exactly what is to be done and all things needed from me?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
2019. "Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03920267.
All > Systemic Lupus Erythematosus > Lupus
~40 spots leftby Mar 2025
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