Calendario›AMGN›HZN-825

HZN-825

A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis

Ensayo de AMGEN INC en Fibrosis pulmonar idiopatica.

Más ensayos de: Fibrosis pulmonar idiopática.

Fase

Fase 2

Estado

Interrumpido

Participantes

153

previstos

Centros

82

Fin del objetivo primario

jul 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en ene 2022.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The trial was terminated due to not meeting primary or key secondary endpoints.».

Qué mide

Core Phase: Change in FVC % Predicted From Baseline to Week 52 (del registro, en inglés) (inicio y semana 52)

Cómo lo describe el promotor

En el documentoEn inglés, del registroHZNP-HZN-825-303 (HARBOR) comprises of 2 parts. Part 1 (Core Phase) is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety and tolerability of HZN-825 in participants with Idiopathic Pulmonary Fibrosis (IPF). Part 2 (Extension Phase) is an optional, open-label, repeat-dose, multicenter extension of the Core Phase. The trial will include up to an 8-week Screening Period and a 52-week Double-blind Treatment Period in the Core Phase and 52 weeks of open-label HZN-825 treatment in the Extension Phase. During the Core Phase, participants will be screened within 8 weeks prior to the baseline (Day 1) Visit. Approximately 135 participants who meet the trial eligibility criteria will be randomly assigned in a 1:1:1 ratio on Day 1 to receive HZN-825 300 mg QD, HZN-825 300 mg BID or matching placebo orally for 52 weeks using the following 2 stratification factors: 1. Concomitant use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no 2. Forced vital capacity (FVC) % predicted at Baseline: ≥70% or \<70% Participants who complete the 52-week Double blind Treatment Period of the Core Phase of the trial will be invited to extend their participation in the 52-week Extension Phase of the trial.

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Todos los de AMGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05032066), actualizada en dic 2025.