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
Market
0.0%
Details
- Resolved Date
- 1/29/26
- Study Completion
- 1/12/26
- Company
- Genentech, Inc.
- Ticker
- RHHBY
- Type
- Trial Status
- Terminated
- Trial Size
- 286
- Volume
- $0
- NCT
- NCT05785624
- Drug Description
- 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.
Resolution Evidence
- Outcome
- NO
- Status
- Resolved
- Settlement Date
- 4/1/26 UTC
- Executive Summary
Public evidence indicates a negative trial outcome. Roche said the Phase 2 IPF/SSc-ILD vixarelimab study failed a futility review and was unlikely to achieve its efficacy objectives, and Roche subsequently removed RG6536 from Phase II in its Jan. 29, 2026 pipeline update.
Sources
Web Searchfiercebiotech.com1/29/26
Roche drops $100M Kiniksa fibrosis drug from phase 2 pipeline as part of quarterly clearout
Roche said the vixarelimab Phase 2 study in idiopathic pulmonary fibrosis/systemic sclerosis-associated ILD hit a futility analysis and was unlikely to achieve its efficacy objectives; no new safety signals were identified.
View source
Sponsorassets.roche.com1/29/26
Roche Group development pipeline — Q4 2025 update
Roche’s Jan. 29, 2026 pipeline update lists RG6536 vixarelimab for IPF/SSc-ILD under 'Removed from phase II,' consistent with discontinuation after the negative futility review.
View source
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