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HZN-825 BID

A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

Ensayo de AMGEN INC en Diffuse Cutaneous Systemic Sclerosis · Sclerosis, Systemic (del registro, en inglés).

Fase

Fase 2

Estado

Interrumpido

Participantes

301

previstos

Centros

4

Fin del objetivo primario

feb 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en nov 2021.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The study was terminated due to meeting pre-defined criteria for futility.».

Qué mide

Change From Baseline in Forced Vital Capacity Percent (FVC%) Predicted at Week 52 (del registro, en inglés) (inicio y semana 52)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 6 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. The trial will include up to a 42-day Screening Period and a 52-week Double-blind Treatment Period. Participants will take their first dose of trial drug at the clinic and will participate in trial visits at Week 4 and every 6 weeks thereafter until Week 52. All participants who complete the Double-blind Treatment Period (Week 52) will be eligible to enter a 52-week extension trial (HZNP-HZN-825-302, NCT05626751). Participants not entering the extension trial will participate in a Safety Follow-up Visit 4 weeks after the last dose of trial drug.

Más ensayos de AMGN

Todos los de AMGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04781543), actualizada en feb 2026.