A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis and in Participants With Systemic Sclerosis-Associated Interstitial Lung Disease

Summary

The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks. Cohort 1 has completed enrollment and has been closed for further enrollment. Cohort 2 is enrolling participants.

Timeline

Start

2023-05-26

Primary completion

2026-01-12

Completion

2026-01-12

Outcome

Outcome not reported

Stopped: “Sponsor decided to discontinue the study after review of clinical data by the iDMC. This decision was based on unblinded evaluation of clinical efficacy which showed a trend towards futility \& was not related to any safety concerns of vixarelimab.”

Drugs

Indications