Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active SLE (POETYK SLE-2)

JRCT ID: jRCT2011230001

Registered date:07/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus
• Date of first enrollment: 24/05/2023
• Target sample size: 490
• Countries of recruitment: USA,Japan,Argentina,Japan,Australia,Japan,Brazil,Japan,Chile,Japan,Czech Republic,Japan,Hungary,Japan,Mexico,Japan,Poland,Japan,Portugal,Japan,Spain,Japan,Taiwan,Japan,United Kingdom,Japan,Peru,Japan,Greece,Japan,Singapore,Japan
• Study type: Interventional

Intervention(s)

-Deucravacitinib
-Placebo

Outcome(s)

• Primary Outcome: Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response at week 52

Secondary Outcome

-Proportion of participants who achieve BICLA response at Week 52
-Proportion of participants who achieve both SRI(4) and BICLA (dual responders) at Week 52
-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 at Week 52
-Proportion of participants who achieve LLDAS at Week 52
-Proportion of participants taking <= 7.5 mg per day prednisone (or equivalent) at Week 24 with no dose increase beyond protocol specified limits to Week 52
-Proportion of participants with >= 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints at Week 52
-Change from baseline in patient-reported fatigue according to FACIT-Fatigue at Week 52
-Number of participants with adverse events (AEs) [ Time Frame: Up to 156 weeks ]
Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 156 weeks ]
Number of participants with AEs leading to discontinuation of treatment [ Time Frame: Up to 156 weeks ]
Number of participants with AEs leading to study discontinuation [ Time Frame: Up to 156 weeks ]
Number of participants with target adverse events of special interest (AESIs) [ Time Frame: Up to 156 weeks ]
Number of participants with laboratory abnormalities [ Time Frame: Up to 156 weeks ]
Number of participants with electrocardiogram (ECG) abnormalities [ Time Frame: Up to 156 weeks ]
Number of participants with vital sign abnormalities [ Time Frame: Up to 156 weeks ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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 Sjogren'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 B - D-glucan assay

Related Information

• Primary Sponsor: Hobar Coburn
• Secondary ID(s): NCT05620407