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

NCT ID: NCT07284459

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Idiopathic Pulmonary Fibrosis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PIPE-791 Dose A

Group Type EXPERIMENTAL

PIPE-791 Dose A

Intervention Type DRUG

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

PIPE-791 Dose B

Group Type EXPERIMENTAL

PIPE-791 Dose B

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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PIPE-791 Dose A

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

Intervention Type DRUG

PIPE-791 Dose B

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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PIPE-791 PIPE-791

Eligibility Criteria

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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)

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Contineum Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mudiaga O Sowho, MD, MPH

Role: STUDY_DIRECTOR

Contineum Therapeutics

Locations

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Dr. Anil Dhar Medicine Professional Corporation

Windsor, Ontaria, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Nikki Nepomuceno

Role: CONTACT

Phone: 858-333-5280

Email: [email protected]

Marietta Franco

Role: CONTACT

Phone: 650-450-6634

Email: [email protected]

Other Identifiers

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CTX-791-201

Identifier Type: -

Identifier Source: org_study_id