Health Trials

Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis

ConditionIdiopathic Pulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorContineum Therapeutics

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PIPE-791 Dose A

    Drug

    Participants will receive a daily oral dose of PIPE-791 in tablet form

  • PIPE-791 Dose B

    Drug

    Participants will receive a daily oral dose of PIPE-791 in tablet form

  • Placebo

    Drug

    Participants will receive a daily oral dose of matching Placebo in tablet form

Treatment groups

324 Participants
are divided into 3 treatment groups
Group A: PIPE-791 Dose AExperimental treatment 1 intervention
Group B: PIPE-791 Dose BExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Absolute change in forced vital capacity (FVC) (mL)

Time frame
From baseline to Week 26

Secondary outcomes

1

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
2

Relative change in FVC (mL)

Additional assessment of disease progression through lung function measurements

Time frame
From baseline to Week 26
3

Proportion of participants with a ≥10% absolute decline in percent predicted FVC (ppFVC)

Time frame
From baseline to Weeks 12 and Week 26
4

Time to first ≥10% absolute decline in ppFVC

Time frame
From baseline to time of first ≥10% absolute decline, up to Week 26

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Contineum Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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