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Looking for participantsPhase2

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

Sponsor: Contineum Therapeutics

NCT ID: NCT07284459

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
PIPE-791 Dose A (drug), PIPE-791 Dose B (drug), Placebo (drug)
How long the study runs
Study runs about 29 months (dates as stated)
About the drug or intervention
PIPE-791 Dose A — drug: Participants will receive a daily oral dose of PIPE-791 in tablet form · PIPE-791 Dose B — drug: Participants will receive a daily oral dose of PIPE-791 in tablet form · Placebo — drug: Participants will receive a daily oral dose of matching Placebo in tablet form
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years and over
Who
All
Number of participants
324
Started
2026-01-08
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for idiopathic pulmonary fibrosis
  • • Phase2 - 324 participants
  • • 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

Who can take part?

  • • Ages 40 Years and over
  • • Diagnosed with idiopathic pulmonary fibrosis

Where?

  • • Leicester - NIHR Leicester Biomedical Research Centre - Glenfield Hospital
  • • London - St Bartholomew's Hospital - PPDS
  • • Southampton - Southampton General Hospital
  • • Edinburgh - Royal Infirmary of Edinburgh
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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 participants 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 participants will be enrolled into one of three treatment arms, PIPE-791 Dose A, PIPE-791 Dose B, or placebo.

Idiopathic Pulmonary Fibrosis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Male or female ≥ 40 years of age at the time of Randomization.
  • ✓Percent predicted (pp) FVC ≥ 40% on Screening spirometry.
  • ✓Participants may enter the study whether or not they are receiving background nintedanib or pirfenidone therapy...

Who cannot take part

  • ✗Those with a history of interstitial lung disease (ILD) other than IPF are not eligible.
  • ✗Those with lung 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.
  • ✗Female participants must not be of childbearing potential.
  • ✗Additional inclusion and exclusion criteria apply.
See the full 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.

Where Is This Study? (7 UK sites)

NIHR Leicester Biomedical Research Centre - Glenfield Hospital

Leicester LE3 9QP, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

St Bartholomew's Hospital - PPDS

London EC1A 7BE, United Kingdom

Recruiting

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Royal Infirmary of Edinburgh

Edinburgh EH16 4SA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

Perth Royal Infirmary

Perth PH1 1NX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

Birmingham Heartlands Hospital

Birmingham B3 3HX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Royal Brompton Hospital

London SW3 6NP, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

How to Get in Touch

Nikki Nepomuceno

Sponsor contact

CONTACT

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

Marietta Franco

Sponsor contact

CONTACT

650-450-6634 mfranco@contineum-tx.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10