Trials / Terminated
TerminatedNCT05785624
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
A Two-Cohort, Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of Vixarelimab Compared With Placebo in Patients With Idiopathic Pulmonary Fibrosis and in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 286 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vixarelimab | Vixarelimab will be administered as per the schedule specified in the respective arms. |
| DRUG | Placebo | Placebo will be administered as per the schedule specified in the respective arms. |
Timeline
- Start date
- 2023-05-26
- Primary completion
- 2026-01-12
- Completion
- 2026-01-12
- First posted
- 2023-03-27
- Last updated
- 2026-02-09
Locations
114 sites across 19 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, France, Germany, Greece, Israel, Italy, Mexico, New Zealand, Poland, South Africa, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05785624. Inclusion in this directory is not an endorsement.