PIPE-791 treatment for people with idiopathic pulmonary fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2 trial will assign about 324 adults with IPF to one of two PIPE-791 dose arms or placebo. The active treatment period is 26 weeks with up to 36 weeks total per participant including screening and follow-up. The study will collect data on efficacy, safety, tolerability, and pharmacokinetics, and allows background antifibrotic therapy such as nintedanib or pirfenidone. Eligibility requires a confirmed IPF diagnosis per guideline criteria and adequate lung function to enroll.

Why it matters

Who can join: the full rules

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.

Where it's running

• Instituto Ave Pulmo
  Mar del Plata, Buenos Aires, Argentina Recruiting
• Centro Respiratorio Quilmes
  Quilmes, Buenos Aires, Argentina Recruiting
• CINME S.A. - Centro de Investigaciones Metabólicas - Viamonte 2213/2215
  Buenos Aires, Buenos Aires F.D., Argentina Recruiting
• Instituto de Especialidades de la Salud Rosario - Clínica del Tórax
  Rosario, Santa Fe Province, Argentina Recruiting
• Instituto Médico de la Fundación Estudios Clínicos
  Rosario, Santa Fe Province, Argentina Recruiting
• Centro de Diagnóstico Y Rehabilitación - Santa Fe - San Luis
  San Luis, Santa Fe Province, Argentina Recruiting

+59 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Nikki Nepomuceno
• Email: nnepomuceno@contineum-tx.com
• Phone: 858-333-5280

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• New IPF drug ORJ-001 tested in adults with IPF

  A phase 2 study tests ORJ-001 versus placebo in adults with idiopathic pulmonary fibrosis to see if it is tolerated and whether it helps lung function.

  Recruiting at 2 sites Phase 2 Oorja Bio, Inc. · Doral, Florida and 1 other locations · NCT07869147

• Nalbuphine ER for IPF-related chronic cough

  This study tests whether extended-release nalbuphine tablets can reduce chronic cough in people with idiopathic pulmonary fibrosis.

  Recruiting at 4 sites Phase 3 Trevi Therapeutics · Wilmington, Delaware and 3 other locations · NCT07868419

• Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients

  This observational study tests how fast patients with IPF or PPF can inhale through dry powder inhalers with different resistances.

  Recruiting Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07820254

• Photon-counting CT vs standard HRCT to help diagnose IPF and other ILDs

  This study tests whether photon-counting CT can improve identifying IPF and other ILDs compared with standard HRCT for patients discussed in multidisciplinary teams.

  Recruiting Istituto Clinico Humanitas · Rozzano, Italy · NCT07790614

• Rentosertib by mouth for people with idiopathic pulmonary fibrosis

  This is a randomized, placebo-controlled test to see if Rentosertib helps adults with idiopathic pulmonary fibrosis when taken as a pill.

  Recruiting at 12 sites Phase 3 InSilico Medicine Hong Kong Limited · Hefei, Anhui and 46 other locations · NCT07687459

• Inhaled nintedanib powder for IPF in adults

  This study tests whether an inhaled form of nintedanib can safely help adults with idiopathic pulmonary fibrosis.

  Recruiting Phase 2 Mannkind Corporation · Windsor, Ontario · NCT07679893

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.