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Nerandomilast Added to Mycophenolate for Treatment of Pulmonary Fibrosis
NCT07570888Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Jun 2026
- Primary completion
- Jun 2027
- Sponsor
- University of British Columbia
- Modality
- Small Molecules
- Drugs
- nerandomilast
- Conditions
- pulmonary fibrosis (PF)interstitial lung disease (ILD)
01
Overview
Phase 4, open-label, single-arm trial of nerandomilast in pulmonary fibrosis (PF) and interstitial lung disease (ILD), sponsored by University of British Columbia. Primary endpoint: Persistency of nerandomilast at 4 months. Planned start Jun 2026; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Participants already receiving treatment with mycophenolate
Participant who are already treated with mycophenolate and have pulmonary fibrosis will receive also treatment with nerandomilast.
03
Who it enrols
Patients with non-IPF pulmonary fibrosis with >= 10% fibrosis on HRCT, stable on mycophenolate, with FVC >= 45% and DLCO >= 25%.
04
Endpoints
Primary
Persistency of nerandomilast
Secondary
Frequency of adverse events
Forced Vital Capacity
Diffusion capacity of the lung for carbon monoxide
Patient-reported outcome measures
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