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Evaluating the effectiveness of deucravacitinib for active systemic lupus erythematosus

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2)

Phase 3 Interventional Bristol-Myers Squibb · NCT05620407

This study is testing if a new medication called deucravacitinib can help people with active systemic lupus erythematosus feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment490 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsprednisone, deucravacitinib
Locations199 sites (La Jolla, California and 198 other locations)
Trial IDNCT05620407 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness and safety of deucravacitinib compared to a placebo in patients with active moderate to severe systemic lupus erythematosus (SLE). Participants must have a confirmed diagnosis of SLE and meet specific disease activity criteria. The study will involve administering deucravacitinib or a placebo to eligible participants and monitoring their responses over time. The goal is to determine if deucravacitinib can provide significant improvements in managing SLE symptoms.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with systemic lupus erythematosus at least 24 weeks prior, exhibiting moderate to severe disease activity.

Not a fit: Patients with mild SLE or those not meeting the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from systemic lupus erythematosus.

How similar studies have performed: Other studies have shown promise with similar approaches in treating autoimmune diseases, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

* Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit.
* Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.
* 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.
* Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry.
* At least one SLE background therapy(immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation.
* Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant.

Exclusion Criteria

* Diagnosis of drug-induced SLE rather than idiopathic SLE.
* Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded -SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded.
* Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria.
* Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS.
* History of congenital or acquired immunodeficiency.
* Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization -Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria).
* Taking more than 1 immunosuppressant at screening.
* In Japan only: Participants with positive result of β - D-glucan assay.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

La Jolla, California and 198 other locations

+149 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic Lupus ErythematosusAutoimmune DiseasesImmune System DiseasesConnective Tissue DiseasesImmune-mediated DiseasesActive Systemic Lupus ErythematosusLupusSLE
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.