Idiopathic Pulmonary Fibrosis
Conditions
Keywords
Idiopathic Pulmonary Fibrosis, PIPE 791, Pulmonary Fibrosis, IPF, ILD, Interstitial lung disease
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.
Detailed description
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.
Interventions
DRUGPIPE-791 Dose A
Participants will receive a daily oral dose of PIPE-791 in tablet form
DRUGPIPE-791 Dose B
Participants will receive a daily oral dose of PIPE-791 in tablet form
DRUGPlacebo
Participants will receive a daily oral dose of matching Placebo in tablet form
Sponsors
Contineum Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change in forced vital capacity (FVC) (mL) | From baseline to Week 26 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the safety and tolerability of PIPE-791 compared to placebo based on percentage of treatment-emergent adverse events (TEAE) | From baseline to Week 30 | — |
| Relative change in FVC (mL) | 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) | From baseline to Weeks 12 and Week 26 | — |
| Time to first ≥10% absolute decline in ppFVC | From baseline to time of first ≥10% absolute decline, up to Week 26 | — |
| Absolute change in ppFVC | From baseline to Week 26 | Additional assessment of disease progression through lung function measurements |
| Relative change in ppFVC | From baseline to Week 26 | Additional assessment of disease progression through lung function measurements |
| Change in quantitative CT-derived lung fibrosis burden on HRCT | From baseline to Week 26 | Additional assessment of disease progression through imaging |
Countries
Argentina, Australia, Canada, Chile, Israel, New Zealand, Serbia, South Korea, United Kingdom
Contacts
CONTACTNikki Nepomuceno
CONTACTMarietta Franco
STUDY_DIRECTORMudiaga O Sowho, MD, MPH
Contineum Therapeutics
Outcome results
None listed