Testing PIPE-791 Dose A against a placebo for idiopathic pulmonary fibrosis
Official title: Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
- Phase 2
- 3 groups
- Sites in Vancouver, Ajax and 5 more cities
- Recruiting
Interventions
- Medication
PIPE-791 Dose A
Participants will receive a daily oral dose of PIPE-791 in tablet form
- Medication
PIPE-791 Dose B
Participants will receive a daily oral dose of PIPE-791 in tablet form
- Medication
Placebo
Participants will receive a daily oral dose of matching Placebo in tablet form
Canadian Sites (7)
7 of 7 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
- Recruiting
Dynamic Drug Advancement Ltd.
Ajax, Ontario
- Recruiting
Toronto General Hospital
Toronto, Ontario
- Recruiting
Dr. Anil Dhar Medicine Professional Corporation
Windsor, Ontario
- Recruiting
Centre d'investigation Clinique Mauricie
Trois-Rivières, Quebec City
- Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
Québec, Quebec
Eligibility Criteria
See who this study is looking for10 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male or female ≥ 40 years of age at the time of RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +A diagnosis of IPF within 7 years prior to ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →, based on the 2022 ATS/ERS/JRS/ALAT practice guideline as confirmed by the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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.
Exclusion
- −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 ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →, 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.
- −Additional inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply.
- −Female participants must not be of childbearing potential.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives PIPE-791 Dose A.
Registry label: A: PIPE-791 Dose A
Group B receives PIPE-791 Dose B.
Registry label: B: PIPE-791 Dose B
Group C, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: C: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 40 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 324 people.
The study is currently expected to finish around June 2028.
The main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 26.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Absolute change in forced vital capacity (FVC) (mL) — measured over From baselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 26.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07284459 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PIPE-791 Dose ADrug
Participants will receive a daily oral dose of PIPE-791 in tablet form
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PIPE-791 Dose BDrug
Participants will receive a daily oral dose of PIPE-791 in tablet form
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Participants will receive a daily oral dose of matching Placebo in tablet form
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 40 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 40 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 26.
The study as a whole is currently expected to finish around 2028-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 324 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Vancouver, British Columbia, Canada; Ajax, Ontario, Canada; Toronto, Ontario, Canada; Windsor, Ontario, Canada; Montreal, Quebec, Canada; Québec, Quebec, Canada, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.