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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE-791 in Subjects with Idiopathic Pulmonary Fibrosis

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521901-42-00
Enrollment
69
Registered
2026-08-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Brief summary

Change in FVC (mL) from Baseline to Week 26

Detailed description

•The percentage of subjects (%) with Treatment Emergent Adverse Events (TEAE), • Relative change in FVC (mL) from Baseline to Week 26, • Absolute change and relative change in percent predicted FVC (ppFVC) (%) from Baseline to Week 26, • Proportion of participants with a ≥ 10% absolute decline in ppFVC (%) at Week 12 and 26 from Baseline, • Time to first ≥ 10% absolute decline in ppFVC (%), • Change in quantitative CT-derived lung fibrosis burden on HRCT

Interventions

DRUGPlacebo to PIPE-791

Sponsors

Contineum Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in FVC (mL) from Baseline to Week 26

Secondary

MeasureTime frame
•The percentage of subjects (%) with Treatment Emergent Adverse Events (TEAE), • Relative change in FVC (mL) from Baseline to Week 26, • Absolute change and relative change in percent predicted FVC (ppFVC) (%) from Baseline to Week 26, • Proportion of participants with a ≥ 10% absolute decline in ppFVC (%) at Week 12 and 26 from Baseline, • Time to first ≥ 10% absolute decline in ppFVC (%), • Change in quantitative CT-derived lung fibrosis burden on HRCT

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 27, 2026