RecruitingPhase 3NCT07687459

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

A Prospective Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Rentosertib (INS018_055) Administered Orally Over 52 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Sponsor

InSilico Medicine Hong Kong Limited

Enrollment

320 participants

Start Date

Sep 9, 2026

Study Type

INTERVENTIONAL

Conditions

Idiopathic Pulmonary Fibrosis

Summary

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.

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called INS018_055 tablets and a drug called Placebo for people with idiopathic pulmonary fibrosis. The study is currently recruiting participants at 47 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGINS018_055 tablets

Dosage form: Tablets； Frequency of administration: Orally QD. Other Names: Rentosertib

DRUGPlacebo

Dosage Form: Tablet; Frequency of administration: Orally QD.

Locations(47)

Anhui Chest Hospital

Hefei, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, China

The Second Affiliated Hospital of Xiamen Medical College

Xiamen, Fujian, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Hainan General Hospital

Haikou, Hainan, China

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The People's Hospital of Anyang City

Anyang, Henan, China

Nanyang First People's Hospital

Nanyang, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Yichang Central People's Hospital

Yichang, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

The Xiangya Hospital of Central South University

Changsha, Hunan, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Jiangxi Provincial People' Hospital

Nanchang, Jiangxi, China

The Second Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Medical College

Xi'an, Shaanxi, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Introduction of the First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shanghai Pulmonary Hospital Affiliated to Tongji University

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Yuncheng Central Hospital

Yuncheng, Shanxi, China

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The First People Hospital of Yunnan Province

Kunming, Yunnan, China

Affiliated Hangzhou First People's Hospital,School of Medicine, Westlake University

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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NCT07687459

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