Recruiting
Phase 2

PIPE-791

Sponsor:

Contineum Therapeutics

Code:

NCT07284459

Conditions

Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

PIPE-791 Dose A

PIPE-791 Dose B

Placebo

Study Details

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 participants with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.

Conditions

Idiopathic Pulmonary Fibrosis

Study ID

NCT07284459

Start date

Jan 8, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 2022 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT consistent with usual interstitial pneumonia (UIP) or probable UIP.
  • Percent predicted (pp) FVC ≥ 40% on Screening spirometry.
  • Participants may enter the study whether or not they are receiving background nintedanib or pirfenidone therapy approved for the treatment of IPF, 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.
  • Female participants must not be of childbearing potential.

Additional inclusion and exclusion criteria apply.

Study Design

Enrollment

324 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PIPE-791 Dose A

experimental: PIPE-791 Dose B

placebo comparator: Placebo

Interventions

PIPE-791 Dose A

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

PIPE-791 Dose B

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

Placebo

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

Primary outcome measure

  • Absolute change in forced vital capacity (FVC) (mL) [ Time Frame: From baseline to Week 26 ]

Central Contacts and Locations

Central contacts

Nikki Nepomuceno

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

Marietta Franco

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

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Toronto General Hospital

Recruiting

Toronto, Ontaria, Canada, M5G 2C4

Dynamic Drug Advancement Ltd.

Recruiting

Ajax, Ontario, Canada, L1S 2J5

Dr. Anil Dhar Medicine Professional Corporation

Recruiting

Windsor, Ontario, Canada, N8X 5A6

Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval

Recruiting

Québec, Quebec, Canada, G1V 4G5

Centre d'investigation Clinique Mauricie

Recruiting

Trois-Rivières, Quebec, Canada, G8T 7A1

More Information

Sponsor

Contineum Therapeutics

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Contineum Therapeutics on 2026-08-26.