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

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.
Brief Title
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
Central Contacts
Central Contact Role
Contact
Central Contact Phone
855-907-3286
Central Contact Email
Clinical.Trials@bms.com
Central Contact Role
Contact
Completion Date
Completion Date Type
Estimated
Conditions
Systemic Lupus Erythematosus
Eligibility 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.
Inclusion 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.

Inclusion/
Gender
All
Gender Based
false
Keywords
Autoimmune Diseases
Immune System Diseases
Connective Tissue Diseases
Immune-mediated Diseases
Active Systemic Lupus Erythematosus
Lupus
SLE
Deucravacitinib
Tyk2
POETYK
POETYK SLE
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT05617677
Org Class
Industry
Org Full Name
Bristol-Myers Squibb
Org Study Id
IM011-246
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
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)
Primary Outcomes
Outcome Measure
Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response
Outcome Time Frame
At week 52
Secondary Ids
Secondary Id
2022-500699-76
Secondary Outcomes
Outcome Time Frame
At week 52
Outcome Measure
Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response
Outcome Time Frame
At week 52
Outcome Measure
Proportion of participants who achieve both SRI(4) and BICLA (dual responders)
Outcome Time Frame
At week 52
Outcome Measure
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
Outcome Time Frame
At week 52
Outcome Measure
Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)
Outcome Time Frame
Up to 52 weeks
Outcome Measure
Proportion of participants taking ≤ 7.5 mg/day prednisone (or equivalent) at Week 24 with no dose increase beyond protocol-specified limits
Outcome Time Frame
At week 52
Outcome Measure
Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints
Outcome Time Frame
At week 52
Outcome Measure
Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Outcome Time Frame
Up to 156 weeks
Outcome Measure
Number of participants with adverse events (AEs)
Outcome Time Frame
Up to 156 weeks
Outcome Measure
Number of participants with serious adverse events (SAEs)
Outcome Time Frame
Up to 156 weeks
Outcome Measure
Number of participants with AEs leading to discontinuation of treatment
Outcome Time Frame
Up to 156 weeks
Outcome Measure
Number of participants with AEs leading to study discontinuation
Outcome Time Frame
Up to 156 weeks
Outcome Measure
Number of participants with target adverse events of special interest (AESIs)
Outcome Time Frame
Up to 156 weeks
Outcome Measure
Number of participants with laboratory abnormalities
Outcome Time Frame
Up to 156 weeks
Outcome Measure
Number of participants with electrocardiogram (ECG) abnormalities
Outcome Time Frame
Up to 156 weeks
Outcome Measure
Number of participants with vital sign abnormalities
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
NOA SHWARTZ
Investigator Email
nshwartz@montefiore.org