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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Lupus (POETYK SLE-1 Trial)

Phase 3
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
One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening
Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 156 weeks
Awards & highlights

POETYK SLE-1 Trial Summary

This trial tests a new drug to treat active Systemic Lupus Erythematosus (SLE) to see if it's safe and effective. #SLE #clinicaltrial

Who is the study for?
This trial is for adults with active moderate to severe Systemic Lupus Erythematosus (SLE) who have a certain level of disease activity. Participants must have been diagnosed at least 24 weeks prior and be on stable SLE medication. Those with lupus overlap syndromes, recent serious infections, multiple immunosuppressants, or unstable neuropsychiatric manifestations cannot join.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Deucravacitinib versus a placebo in treating SLE. It aims to see if Deucravacitinib can help manage symptoms better than an inactive substance without any therapeutic effect.See study design
What are the potential side effects?
While specific side effects for Deucravacitinib are not listed here, common drug-related side effects in trials may include nausea, headaches, possible increased risk of infection due to immune system suppression, and potential liver issues.

POETYK SLE-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have tested positive for specific autoimmune markers.
Select...
My lupus is active, with a score of 6 or more, affecting my joints, skin, or causing rash.

POETYK SLE-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 156 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 156 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
Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response
Secondary outcome measures
Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Number of participants with AEs leading to discontinuation of treatment
Number of participants with AEs leading to study discontinuation
+12 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

POETYK SLE-1 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1: DeucravacitinibExperimental Treatment1 Intervention
Group II: Arm 2: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deucravacitinib
2021
Completed Phase 4
~160

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,631 Previous Clinical Trials
4,126,178 Total Patients Enrolled
5 Trials studying Lupus
1,111 Patients Enrolled for Lupus

Media Library

Deucravacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05617677 — Phase 3
Lupus Research Study Groups: Arm 1: Deucravacitinib, Arm 2: Placebo
Lupus Clinical Trial 2023: Deucravacitinib Highlights & Side Effects. Trial Name: NCT05617677 — Phase 3
Deucravacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05617677 — Phase 3

Frequently Asked Questions

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

Am I eligible to enroll in this research study?

"Up to 490 patients with systemic lupus erythematosus between the ages of 18 and 75 will be admitted into this trial. Eligibility criteria include: a positive ANA reading ≥ 1:80, a SLEDAI-2K score ≥ 6 points, clinical SLEDAI 2K score ≥ 4 points with joint involvement and/or rash, a diagnosis of SLE at least 24 weeks before screening, meeting the 2019 EULAR/ACR classification criteria for SLE, and being on one or more background therapies (immunosuppressant and/or antimalarial) for 12 weeks prior"

Answered by AI

Are there any more positions available for test subjects?

"According to the information readily available on clinicaltrials.gov, this trial is no longer looking for patients as of their last update on November 8th, 2022. This study was initially posted on 21/11/2022. Right now, there are 128 other trials that are actively recruiting patients."

Answered by AI

Does this research include elderly participants?

"The age requirement for this clinical trial is that patients must be over 18 but under 75 years old."

Answered by AI

What is the status of Deucravacitinib's FDA approval?

"We believe that arm 1 of the deucravacitinib clinical trial is safe, as it has received a score of 3. This is due to there being data supporting efficacy and safety from multiple rounds of testing."

Answered by AI

Is this trial taking place in more than one urban location?

"With 21 sites available, patients have plenty of options for participating in this study. Some notable locations include the Arthritis & Rheumatology Research Institute in Allen, Yale University School of Medicine in New Haven, and the University of Florida College of Medicine in Gainesville."

Answered by AI
~280 spots leftby Dec 2025