Study Evaluation Rentosertib (INS018_055) Administered Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Sponsor
InSilico Medicine Hong Kong Limited
Study ID
NCT07687459
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

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

Interventions

  • INS018_055 tablets — DRUG
    Dosage form: Tablets； Frequency of administration: Orally QD. Other Names: Rentosertib
  • Placebo — DRUG
    Dosage Form: Tablet; Frequency of administration: Orally QD.

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Rentosertib (INS018\_055) administered orally in Patients with Idiopathic Pulmonary Fibrosis. The purpose of this study is to evaluate if Rentosertib (INS018\_055) works to treat patients with Idiopathic Pulmonary Fibrosis in adults. It will also learn about the safety of Rentosertib (INS018\_055). In this study, Rentosertib (INS018\_055) will be compared to a placebo (a look-alike substance that contains no drug) to investigate if Rentosertib (INS018\_055) works to treat Idiopathic Pulmonary Fibrosis.

Key Dates

First listed
Jul 7, 2026
Start date
Aug 30, 2026
Status verified
Jun 2026
Primary completion
Oct 30, 2029
Completion
Oct 30, 2029

Study Design

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

Arms

  • Experimental: Active
    Patients assigned will receive ISN018\_055 tablets orally QD for 52 weeks
  • Placebo Comparator: Placebo
    Patients assigned will receive matching placebo orally QD for 52 weeks

Primary Outcome Measure

the annual rate of forced vital capacity (FVC; mL) decline over 52 weeks. [ Time Frame: Weeks 0,4,12,26,39,52 ]

Central Contacts

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