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A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)

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ClinicalTrials.gov Identifier: NCT05617677
Recruitment Status : Recruiting
First Posted : November 15, 2022
Last Update Posted : September 18, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Deucravacitinib Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 490 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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-1)
Actual Study Start Date : January 12, 2023
Estimated Primary Completion Date : December 17, 2025
Estimated Study Completion Date : December 17, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: Deucravacitinib Drug: Deucravacitinib
Specified dose on specified days
Placebo Comparator: Arm 2: Placebo Other: Placebo
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response [ Time Frame: At week 52 ]

Secondary Outcome Measures :
  1. Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response [ Time Frame: At week 52 ]
  2. Proportion of participants who achieve both SRI(4) and BICLA (dual responders) [ Time Frame: At week 52 ]
  3. Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score [ Time Frame: At week 52 ]
  4. Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS) [ Time Frame: At week 52 ]
  5. Proportion of participants taking ≤ 7.5 mg/day prednisone (or equivalent) at Week 24 with no dose increase beyond protocol-specified limits [ Time Frame: Up to 52 weeks ]
  6. Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints [ Time Frame: At week 52 ]
  7. Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue [ Time Frame: At week 52 ]
  8. Number of participants with adverse events (AEs) [ Time Frame: Up to 156 weeks ]
  9. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 156 weeks ]
  10. Number of participants with AEs leading to discontinuation of treatment [ Time Frame: Up to 156 weeks ]
  11. Number of participants with AEs leading to study discontinuation [ Time Frame: Up to 156 weeks ]
  12. Number of participants with target adverse events of special interest (AESIs) [ Time Frame: Up to 156 weeks ]
  13. Number of participants with laboratory abnormalities [ Time Frame: Up to 156 weeks ]
  14. Number of participants with electrocardiogram (ECG) abnormalities [ Time Frame: Up to 156 weeks ]
  15. Number of participants with vital sign abnormalities [ Time Frame: Up to 156 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05617677


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com/SLE 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05617677    
Other Study ID Numbers: IM011-246
2022-500699-76 ( EudraCT Number )
First Posted: November 15, 2022    Key Record Dates
Last Update Posted: September 18, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Autoimmune Diseases
Immune System Diseases
Connective Tissue Diseases
Immune-mediated Diseases
Active Systemic Lupus Erythematosus
Lupus
 SLE
Deucravacitinib
Tyk2
POETYK
POETYK SLE
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Deucravacitinib
 Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action