A 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjogren's Syndrome (TWINSS)

CompletadoFase 2ClinicalTrials.gov

ID: NCT03905525Tipo: INTERVENTIONALInicio: 1 de oct de 2019Fin estimado: 6 de jun de 2023

Traducción no disponible, mostrando original

Resumen

This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.

Descripción detallada

This is a double-blind, randomized, placebo-controlled, multicenter study of CFZ533 in 2 distinct populations (cohorts) of patients with Sjögren's Syndrome: 1) moderate-to-severe disease (systemic and symptomatic involvement) and; 2) low systemic involvement but high symptom burden. The study includes up to 6 weeks screening period, 48 weeks of treatment (divided into treatment periods of 24 weeks each) and 12 weeks follow up. Study treatment will be administered as bi-weekly subcutaneous injections.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Signed informed consent
Male or female patient ≥ 18 years of age
Classification of Sjögren's Syndrome according to ACR/EULAR 2016 criteria (Shiboski et al 2017)
Seropositive for anti-Ro/SSA antibodies
Stimulated whole salivary flow rate of ≥ 0.1 mL/min
ESSDAI ≥ 5 within the 8 predefined organ domains
ESSPRI score of ≥5
ESSDAI \< 5 within 8 domains scored for inclusion criterion for Cohort 1
ESSPRI fatigue subscore ≥ 5 or ESSPRI dryness subscore ≥ 5

Criterios de exclusión

Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principle illness
Use of other investigational drugs
Prior use of B cell depleting therapies, abatacept or any other immunosuppressants unless specifically allowed be the protocol.
Use of steroids at dose \>10 mg/day.
Uncontrolled ocular rosacea (affecting the eye adnexa), posterior blepharitis or Meibomian gland disease (this criterion applies only to patients considered for Cohort 2)
Active viral, bacterial or other infections requiring systemic treatment
Receipt of live/attenuated vaccine within a 2-month period prior to randomization.
Chronic infection with hepatitis B (HBV) or hepatitis C (HCV).
Evidence of active tuberculosis (TB) infection.

Intervenciones

drug

CFZ533

Biological

other

Placebo

liquid placebo for injections

Ubicaciones

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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