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

Sponsor: Bristol-Myers Squibb

Sommario: 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.


TIPOLOGIA STUDIO

Interventistico

FASE

Fase 3


TRATTAMENTO

  • Deucravacitinib
  • Placebo

OBIETTIVO PRIMARIO

  • Misura: Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response
  • Tempo: At week 52
  • Descrizione:

OBIETTIVO SECONDARIO

  • Misura: Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response
  • Tempo: At week 52
  • Descrizione:
  • Misura: Proportion of participants who achieve both SRI(4) and BICLA (dual responders)
  • Tempo: At week 52
  • Descrizione:
  • Misura: 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
  • Tempo: At week 52
  • Descrizione:
  • Misura: Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)
  • Tempo: At week 52
  • Descrizione:
  • Misura: Proportion of participants taking ≤ 7.5 mg/day prednisone (or equivalent) at Week 24 with no dose increase beyond protocol-specified limits
  • Tempo: Up to 52 weeks
  • Descrizione:
  • Misura: Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints
  • Tempo: At week 52
  • Descrizione:
  • Misura: Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
  • Tempo: At week 52
  • Descrizione:
  • Misura: Number of participants with adverse events (AEs)
  • Tempo: Up to 156 weeks
  • Descrizione:
  • Misura: Number of participants with serious adverse events (SAEs)
  • Tempo: Up to 156 weeks
  • Descrizione:
  • Misura: Number of participants with AEs leading to discontinuation of treatment
  • Tempo: Up to 156 weeks
  • Descrizione:
  • Misura: Number of participants with AEs leading to study discontinuation
  • Tempo: Up to 156 weeks
  • Descrizione:
  • Misura: Number of participants with target adverse events of special interest (AESIs)
  • Tempo: Up to 156 weeks
  • Descrizione:
  • Misura: Number of participants with laboratory abnormalities
  • Tempo: Up to 156 weeks
  • Descrizione:
  • Misura: Number of participants with electrocardiogram (ECG) abnormalities
  • Tempo: Up to 156 weeks
  • Descrizione:
  • Misura: Number of participants with vital sign abnormalities
  • Tempo: Up to 156 weeks
  • Descrizione:

CRITERI DI ELIGIBILITA'

  • Criteri di inclusione e esclusione

    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.


SESSO

Tutti


ETA' MINIMA

Età Minima: 18 Years
Età Massima: 75 Years


LUOGO

AOU Policlinico Umberto I
Roma, 00161

Local Institution - 0095
Milano, 20122

Azienda Ospedaliera Universitaria Pisana
Pisa, 56126

Local Institution - 0097
Padova, 35128

Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123

Local Institution - 0072
Milano, 20132

AOU della Campania Luigi Vanvitelli
Napoli, 80131

Local Institution - 0118
Pavia, 27100

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Verona, 37134

REFERENTE PER INFORMAZIONI

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com