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

Sponsor
Contineum Therapeutics
Study ID
NCT07284459
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Dec 16, 2025
Start date
Jan 8, 2026
Status verified
Jul 2026
Primary completion
May 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
324 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PIPE-791 Dose A
  • Experimental: PIPE-791 Dose B
  • Placebo Comparator: Placebo

Primary Outcome Measure

Absolute change in forced vital capacity (FVC) (mL) [ Time Frame: From baseline to Week 26 ]

Central Contacts

Related Studies