Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon
Rechercher Study Connect

Recruiting

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus - IM011-247

Mis à jour: 30 octobre, 2024   |   ClinicalTrials.gov

Résumé imprimable

VOUS ENVISAGEZ CET ESSAI ?
Imprimer cette page et le guide d’essai pour vous aider à parler avec votre médecin.
Utiliser le Guide du participant à l’étude pour découvrir comment participer à un essai clinique. Comprendre les principaux facteurs à envisager avant de prendre une décision et poser des questions à votre équipe soignante.

Détails de l’essai

  • Phase 3

    Phase

  • Sexe(s)

  • 18-75

    Tranche d’âge

  • 100

    Site(s)

  • Recruiting

Options de traitement

Bras de l’étude
INTERVENTION ASSIGNÉE
Experimental: Arm 1: Deucravacitinib
Drug: Deucravacitinib
Placebo Comparator: Arm 2: Placebo
Other: Placebo

Principaux critères d’éligibilité

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 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, with the exception of participants with mononeuritis multiplex and polyneuropathy - 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

Nous vous recommandons vivement de contacter BMS pour signaler les effets secondaires (événements indésirables)
Les effets secondaires (événements indésirables) et les autres événements à signaler sont définis ici
Signaler des plaintes concernant des effets indésirables (effets indésirables) ou des produits: Informations médicales