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Recruiting

A Study of CC-97540 in Participants With Severe, Refractory Systemic Lupus Erythematosus (SLE) - CA061-1001

Mis à jour: 4 novembre, 2024   |   ClinicalTrials.gov

Impression du resumé

SONGEZ-VOUS À PARTICIPER À CET ESSAI?
Imprimez cette page et le guide pour vous aider dans vos échanges avec votre médecin.
Utilisez le guide en matière d’essai pour connaître le processus de participation à un essai clinique. Soyez au fait des principaux facteurs à considérer avant de prendre une décision et dressez la liste des questions à poser à l’équipe de soins de santé.

Détails de l’essai

  • Phase 1

    Phase

  • Sexe(s)

  • 18+

    Tranche d’âge

  • 44

    Emplacement(s)

  • Recruiting

Options de traitement

Groupes de l’étude
INTERVENTION ATTRIBUÉE
Experimental: Administration of CC-97540
Drug: CC-97540, Fludarabine, Cyclophosphamide, Tocilizumab

Principaux critères d’admissibilité

Inclusion Criteria: - Diagnosis of SLE defined as follows: - Fulfilling the 2019 ACR/EULAR classification criteria of SLE - Presence of anti-dsDNA, anti-histone, anti-chromatin, or anti-Sm antibodies - SLE disease activity - Active disease at screening, defined as ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and/or constitutional organ system) - ii) Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin. i) Insufficient response is defined as lack of response, insufficient response or lack of sustained response to appropriate doses. Intolerance is not considered insufficient response ii) Methotrexate and azathioprine use will count as 1 for the purposes of the number of failed treatments. Exclusion Criteria: - Diagnosis of drug-induced SLE rather than idiopathic SLE - Other systemic 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 - Recent or present clinically significant CNS pathology Other protocol-defined Inclusion/Exclusion criteria apply.

Nous vous recommandons fortement 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 effets secondaires (effets indésirables) ou des plaintes concernant la qualité du produit: Informations médicales

Des questions? Le support en direct est disponible 24/7 - Veuillez composer le 833-673-6134 ou Envoyez-nous un courriel

Des questions? Le support en direct est disponible 24/7 -
Veuillez composer le 833-673-6134 ou Envoyez-nous un courriel