A Phase 2 interventional study of PIPE-791 Dose A and PIPE-791 Dose B in Idiopathic Pulmonary Fibrosis, sponsored by Contineum Therapeutics. Recruiting at 109 sites in 19 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Contineum Therapeutics · Phase 2, Interventional, and Treatment
Greece, Portugal, Spain, Denmark, Germany, Belgium
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.
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.
576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.
This study's planned enrollment of 324 is above the median of 55 across 389 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →Contineum Therapeutics is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Additional inclusion and exclusion criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: PIPE-791 Dose A
Drug: PIPE-791 Dose B
Drug: Placebo
Participants will receive a daily oral dose of PIPE-791 in tablet form
Also known as: PIPE-791
Participants will receive a daily oral dose of PIPE-791 in tablet form
Also known as: PIPE-791
Participants will receive a daily oral dose of matching Placebo in tablet form
Absolute change in forced vital capacity (FVC) (mL)
Time frame: From baseline to Week 26
To investigate the safety and tolerability of PIPE-791 compared to placebo based on percentage of treatment-emergent adverse events (TEAE)
Time frame: From baseline to Week 30
Relative change in FVC (mL)
Additional assessment of disease progression through lung function measurements
Time frame: From baseline to Week 26
Proportion of participants with a ≥10% absolute decline in percent predicted FVC (ppFVC)
Time frame: From baseline to Weeks 12 and Week 26
Time to first ≥10% absolute decline in ppFVC
Time frame: From baseline to time of first ≥10% absolute decline, up to Week 26
Absolute change in ppFVC
Additional assessment of disease progression through lung function measurements
Time frame: From baseline to Week 26
Relative change in ppFVC
Additional assessment of disease progression through lung function measurements
Time frame: From baseline to Week 26
Change in quantitative CT-derived lung fibrosis burden on HRCT
Additional assessment of disease progression through imaging
Time frame: From baseline to Week 26
Showing the first 100 of 109 sites across 19 countries. Choose a country and city above to see the rest.
Plan to share: No
No publications or documents are linked to this record.
Greece, Portugal, Spain, Denmark, Germany, Belgium
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: PIPE-791
Idiopathic Pulmonary Fibrosis →
Contineum Therapeutics