Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis

NCT07284459 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CTX-791-201
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in subjects with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; PIPE 791; Pulmonary Fibrosis; IPF; ILD; Interstitial lung disease

Outcome Measures

Primary Outcomes (1)

• Absolute change in forced vital capacity (FVC) (mL)

  From baseline to Week 26

Secondary Outcomes (6)

• To investigate the safety and tolerability of PIPE-791 compared to placebo based on percentage of treatment-emergent adverse events (TEAE)

  From baseline to Week 30

• Relative change in FVC (mL)

  From baseline to Week 26

• Proportion of subjects with a ≥10% absolute decline in percent predicted FVC (ppFVC)

  From baseline to Weeks 12 and Week 26

• Time to first ≥10% absolute decline in ppFVC

  From baseline to time of first ≥10% absolute decline, up to Week 26

• Absolute change in ppFVC

  From baseline to Week 26

Study Arms (3)

PIPE-791 Dose A

EXPERIMENTAL

Drug: PIPE-791 Dose A

PIPE-791 Dose B

EXPERIMENTAL

Drug: PIPE-791 Dose B

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PIPE-791 Dose A DRUG

Subjects will receive a daily oral dose of PIPE-791 in tablet form

Also known as: PIPE-791

PIPE-791 Dose A

PIPE-791 Dose B DRUG

Subjects will receive a daily oral dose of PIPE-791 in tablet form

Also known as: PIPE-791

PIPE-791 Dose B

Placebo DRUG

Subjects will receive a daily oral dose of matching Placebo in tablet form

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 40 years of age at the time of Randomization
• A diagnosis of IPF within 7 years prior to Screening, based on the 2018 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT with verification of usual interstitial pneumonia
• Percent predicted (pp) FVC ≥ 40% on Screening spirometry
• Subjects may enter the study whether or not they are receiving background antifibrotic therapy, approved for the treatment of IPF (nintedanib or pirfenidone, but not both concurrently)

You may not qualify if:

• Those with a history of interstitial lung disease (ILD) other than IPF are not eligible.
• Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible.
• Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible.
• Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible.

Sponsors & Collaborators

• Contineum Therapeutics: lead

Study Sites (2)

Dynamic Drug Advancement Ltd.

Ajax, Ontario, L1S 2J5, Canada

RECRUITING

Dr. Anil Dhar Medicine Professional Corporation

Windsor, Ontario, N8X 5A6, Canada

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mudiaga O Sowho, MD, MPH

  Contineum Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Nikki Nepomuceno

CONTACT

858-333-5280; nnepomuceno@contineum-tx.com

Marietta Franco

CONTACT

650-450-6634; mfranco@contineum-tx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 16, 2025
• Study Start: January 8, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)