NCT07284459 Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
| NCT ID | NCT07284459 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Contineum Therapeutics |
| Condition | Idiopathic Pulmonary Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 324 participants |
| Start Date | 2026-01-08 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 324 participants in total. It began in 2026-01-08 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 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.
Contact & Investigator
Mudiaga O Sowho, MD, MPH
STUDY DIRECTOR
Contineum Therapeutics
Frequently Asked Questions
Who can join the NCT07284459 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Idiopathic Pulmonary Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07284459 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07284459 currently recruiting?
Yes, NCT07284459 is actively recruiting participants. Contact the research team at nnepomuceno@contineum-tx.com for enrollment information.
Where is the NCT07284459 trial being conducted?
This trial is being conducted at San Miguel de Tucumán, Argentina, San Miguel de Tucumán, Argentina, San Miguel de Tucumán, Argentina, Buenos Aires, Argentina and 11 additional locations.
Who is sponsoring the NCT07284459 clinical trial?
NCT07284459 is sponsored by Contineum Therapeutics. The principal investigator is Mudiaga O Sowho, MD, MPH at Contineum Therapeutics. The trial plans to enroll 324 participants.