← Back to Search

Janus Kinase (JAK) Inhibitor

Deucravacitinib for Lupus (POETYK SLE-2 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 156 weeks
Awards & highlights

POETYK SLE-2 Trial Summary

This trial is testing a new drug to treat Systemic Lupus Erythematosus (SLE) to see if it's safe and effective.

Who is the study for?
This trial is for adults with active moderate to severe Systemic Lupus Erythematosus (SLE) who meet specific criteria, including a certain score on the SLEDAI-2K disease activity index and evidence of joint or skin involvement. Participants may be taking stable doses of steroids, antimalarials, or immunosuppressants but cannot have severe lupus nephritis, other autoimmune diseases except some exceptions, recent major infections, or more than one immunosuppressant.Check my eligibility
What is being tested?
The study tests Deucravacitinib's effectiveness and safety against a placebo in treating SLE. Participants will randomly receive either the investigational drug or an inactive substance to compare outcomes between the two groups over time.See study design
What are the potential side effects?
While not specified here, potential side effects could include typical reactions seen with immune-modulating drugs such as increased risk of infection, liver issues, blood cell count changes, nausea, headaches and possible allergic reactions.

POETYK SLE-2 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
Erythrocyte Indices
Secondary outcome measures
Mental disorders
Therapeutic procedure
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-2 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
2,640 Previous Clinical Trials
4,128,974 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: NCT05620407 — Phase 3
Lupus Research Study Groups: Arm 2: Placebo, Arm 1: Deucravacitinib
Lupus Clinical Trial 2023: Deucravacitinib Highlights & Side Effects. Trial Name: NCT05620407 — Phase 3
Deucravacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05620407 — Phase 3

Frequently Asked Questions

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

Does this research project have an age limit for participants?

"The eligibility requirements to take part in this clinical trial are that participants must be over 18 and under 75 years old."

Answered by AI

What is the FDA's stance on deucravacitinib?

"Deucravacitinib, which is found in Arm 1, has received a safety score of 3."

Answered by AI

Are there any prerequisites for participating in this experiment?

"To qualify for this lupus erythematosus clinical trial, patients must be between 18 and 75 years old. Up to 490 individuals will be accepted into the study."

Answered by AI

Does this clinical trial have numerous sites in North America?

"To make travelling as easy as possible for potential participants, the 20 clinical trial sites are located in major cities including Bothell, New york and Orland Park."

Answered by AI

Are there any vacant positions in this trial for new patients?

"The clinical trial, which was first posted on November 21st 2022 and last updated 11 days ago, is not looking for new patients. Although, there are 128 other trials that may have open positions."

Answered by AI

Who else is applying?

What site did they apply to?
East Bay Rheumatology Medical Group, Inc
Hospital for Special Surgery
Precision Comprehensive Clinical Research Solutions - Colleyville
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
2023. "A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05620407.
All > Systemic Lupus Erythematosus > Lupus
~266 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top