Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
- 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.
- Short title
- Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2028-06-01
- First posted
- 2025-12-16
- Registry last updated
- 2026-08-26
- Primary completion date
- 2028-05-01
- Start date
- 2026-01-08
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Contineum Therapeutics
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07284459
- ClinicalTrials.gov ID
- NCT07284459
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Absolute change in forced vital capacity (FVC) (mL)
Timeframe: 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)
Timeframe: From baseline to Week 30
Relative change in FVC (mL)
Timeframe: From baseline to Week 26
Additional assessment of disease progression through lung function measurements
Proportion of participants with a ≥10% absolute decline in percent predicted FVC (ppFVC)
Timeframe: From baseline to Weeks 12 and Week 26
Time to first ≥10% absolute decline in ppFVC
Timeframe: From baseline to time of first ≥10% absolute decline, up to Week 26
Absolute change in ppFVC
Timeframe: From baseline to Week 26
Additional assessment of disease progression through lung function measurements
Relative change in ppFVC
Timeframe: From baseline to Week 26
Additional assessment of disease progression through lung function measurements
Change in quantitative CT-derived lung fibrosis burden on HRCT
Timeframe: From baseline to Week 26
Additional assessment of disease progression through imaging
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 40 Years
- Healthy volunteers
- No
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.
- Instituto Ave PulmoMar del Plata, ArgentinaRecruiting
- Centro Respiratorio QuilmesQuilmes, ArgentinaRecruiting
- Instituto de Especialidades de la Salud Rosario - Clínica del TóraxRosario, ArgentinaRecruiting
- Instituto Médico de la Fundación Estudios ClínicosRosario, ArgentinaRecruiting
- Centro de Diagnóstico Y Rehabilitación - Santa Fe - San LuisSan Luis, ArgentinaRecruiting
- Centro de Investigaciones Médicas Tucumán - PPDSSan Miguel de Tucumán, ArgentinaRecruiting
- CIMER-Centro Integral de Medicina RespiratoriaSan Miguel de Tucumán, ArgentinaRecruiting
- IPR-Investigaciones en Patologías RespiratoriasSan Miguel de Tucumán, ArgentinaRecruiting
- Centro Modelo de Cardiología-Laprida 554San Miguel de Tucumán, ArgentinaRecruiting
- STAT Research S.A.Buenos Aires, ArgentinaRecruiting
- Consultorios Médicos Organización del Buen Ayre SRLBuenos Aires, ArgentinaRecruiting
- Centro Médico Dra de Salvo - Fundacion Respirar - PPDSBuenos Aires, ArgentinaRecruiting
- Instituto de Medicina Respiratoria - IMERCórdoba, ArgentinaRecruiting
- IbaMedicaSanta Fe, ArgentinaRecruiting
- Royal Prince Alfred HospitalCamperdown, AustraliaRecruiting
- Westmead HospitalWestmead, AustraliaRecruiting
- The Prince Charles HospitalChermside, AustraliaRecruiting
- Greenslopes Private HospitalGreenslopes, AustraliaRecruiting
- Austin HealthHeidelberg, AustraliaRecruiting
- The Alfred HospitalMelbourne, AustraliaRecruiting
- Institute for Respiratory HealthMidland, AustraliaRecruiting
- TrialsWest Pty LtdSpearwood, AustraliaRecruiting
- Vancouver General HospitalVancouver, CanadaRecruiting
- Toronto General HospitalToronto, CanadaRecruiting
- Dynamic Drug Advancement Ltd.Ajax, CanadaRecruiting
And 44 more, listed on the interactive page.
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Idiopathic pulmonary fibrosis Primary condition
- Pulmonary fibrosis