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

NCT07284459

RecruitingPhase 2

Sponsor: Contineum Therapeutics

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: PIPE-791 Dose A, PIPE-791 Dose B, Placebo

Countries: Argentina, Australia, Canada, Chile, Israel, New Zealand, Serbia, South Korea

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.

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (68)
  • Mar del Plata, Buenos Aires, Argentina
  • Quilmes, Buenos Aires, Argentina
  • Rosario, Santa Fe Province, Argentina
  • Rosario, Santa Fe Province, Argentina
  • San Luis, Santa Fe Province, Argentina
  • San Miguel de Tucumán, Tucumán Province, Argentina
  • San Miguel de Tucumán, Tucumán Province, Argentina
  • San Miguel de Tucumán, Tucumán Province, Argentina
  • San Miguel de Tucumán, Tucumán Province, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Córdoba, Argentina
  • Santa Fe, Argentina
  • Camperdown, New South Wales, Australia
  • Westmead, New South Wales, Australia
  • Chermside, Queensland, Australia
  • Greenslopes, Queensland, Australia
  • Heidelberg, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Midland, Western Australia, Australia
  • Spearwood, Western Australia, Australia
  • Vancouver, British Columbia, Canada
  • Toronto, Ontaria, Canada
  • Ajax, Ontario, Canada
  • Windsor, Ontario, Canada
  • Montreal, Quebec, Canada
  • Québec, Quebec, Canada
  • Trois-Rivières, Quebec, Canada
  • Curicó, Maule Region, Chile
  • + 38 more on CT.gov