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

May 21, 2026 updated by: Contineum Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and PK of PIPE-791 in subjects with a diagnosis of Idiopathic Pulmonary Fibrosis with or without background treatment. The treatment period is 26 weeks and full study duration is up to 36 weeks including Screening and Follow-Up. Approximately 324 subjects will be enrolled into one of three treatment arms, PIPE-791 Dose A, PIPE-791 Dose B, or placebo.

Study Type

Interventional

Enrollment (Estimated)

324

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Western Australia
      • Midland, Western Australia, Australia, 6056
        • Recruiting
        • Institute for Respiratory Health
      • Spearwood, Western Australia, Australia, 6163
        • Recruiting
        • TrialsWest Pty Ltd
  • Canada
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Recruiting
        • Dynamic Drug Advancement Ltd.
      • Windsor, Ontario, Canada, N8X 5A6
        • Recruiting
        • Dr. Anil Dhar Medicine Professional Corporation
    • Quebec
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Recruiting
        • Centre d'investigation Clinique Mauricie
  • Israel
    • Southern District
      • Ashdod, Southern District, Israel, 7747629
        • Recruiting
        • Assuta Ashdod University Medical Center
      • Ashkelon, Southern District, Israel, 7830604
        • Recruiting
        • The Barzilai University Medical Center
    • Yerushala
      • Jerusalem, Yerushala, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center
  • United Kingdom
    • England
      • Leicester, England, United Kingdom, LE3 9QP
        • Recruiting
        • NIHR Leicester Biomedical Research Centre - Glenfield Hospital
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH16 4SA
        • Recruiting
        • Royal Infirmary of Edinburgh
      • Perth, Scotland, United Kingdom, PH1 1NX
        • Recruiting
        • Perth Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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)

Key Exclusion Criteria:

  • 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.

Additional inclusion and exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Subjects will receive a daily oral dose of matching Placebo in tablet form
Experimental: PIPE-791 Dose A
Drug: PIPE-791 Dose A
Subjects will receive a daily oral dose of PIPE-791 in tablet form
Other Names:
  • PIPE-791
Experimental: PIPE-791 Dose B
Drug: PIPE-791 Dose B
Subjects will receive a daily oral dose of PIPE-791 in tablet form
Other Names:
  • PIPE-791

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change in forced vital capacity (FVC) (mL)
Time Frame: From baseline to Week 26
From baseline to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To investigate the safety and tolerability of PIPE-791 compared to placebo based on percentage of treatment-emergent adverse events (TEAE)
Time Frame: From baseline to Week 30
From baseline to Week 30
Relative change in FVC (mL)
Time Frame: From baseline to Week 26
Additional assessment of disease progression through lung function measurements
From baseline to Week 26
Time to first ≥10% absolute decline in ppFVC
Time Frame: From baseline to time of first ≥10% absolute decline, up to Week 26
From baseline to time of first ≥10% absolute decline, up to Week 26
Proportion of subjects with a ≥10% absolute decline in percent predicted FVC (ppFVC)
Time Frame: From baseline to Weeks 12 and Week 26
From baseline to Weeks 12 and Week 26
Absolute change in ppFVC
Time Frame: From baseline to Week 26
Additional assessment of disease progression through lung function measurements
From baseline to Week 26
Relative change in ppFVC
Time Frame: From baseline to Week 26
Additional assessment of disease progression through lung function measurements
From baseline to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Contineum Therapeutics

Investigators

  • Study Director: Mudiaga O Sowho, MD, MPH, Contineum Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTX-791-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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