Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)

The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic Pulmonary Fibrosis (IPF).

The primary objective is to evaluate the safety and tolerability of INS018_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Intervention / Treatment: Drug: INS018_055; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • The Second Affiliated Hospital of Anhui Medical University
    • Hefei, Anhui, China, 230031
      • Anhui Chest Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
    • Beijing, Beijing Municipality, China, 100041
      • Peking University Shougang Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Provincial People's Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • The Shengjing Hospital of China medical university
  • Shandong
    • Jinan, Shandong, China, 250013
      • Qilu Hospital of Shandong University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Zhongshan Hospital Fudan University
    • Shanghai, Shanghai Municipality, China, 200030
      • Shanghai Chest Hospital
    • Shanghai, Shanghai Municipality, China, 201800
      • Shanghai Pulmonary Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Shanxi Bethune Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • The West China Hospital of Sichuan University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • General Hospital of Tianjin Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • The First Affiliated Hospital - Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female patients aged ≥40 years based on the date of the written informed consent form
2. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
3. In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
4. Subjects with background pirfenidone or nintedanib may be enrolled if their regimen of antifibrotic therapy has been stable for > 8 weeks prior to Visit 1

5. Meeting all of the following criteria during the screening period:

   1. FVC ≥40% predicted of normal
   2. DLCO corrected for Hgb ≥25% and <80% predicted of normal.
   3. forced expiratory volume in the first second/FVC (FEV1/FVC) ratio >0.7 based on pre-bronchodilator value

Exclusion Criteria:

1. Acute IPF exacerbation within 4 months prior to Visit 1 and/or during the screening period, as determined by the investigator
2. Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
3. Female patients who are pregnant or nursing
4. Abnormal ECG findings

Other protocol inclusion and exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Group 4: Placebo once or twice daily up to 12 weeks	Drug: Placebo; Pharmaceutical formulation: Capsules Mode of Administration: Oral
Experimental: INS018_055 30 mg QD; Group 1: INS018_055 once daily up to 12 weeks, low dose	Drug: INS018_055; Pharmaceutical formulation: Capsules Mode of Administration: Oral
Experimental: INS018_055 30 mg BID; Group 2: INS018_055 twice daily up to 12 weeks, low dose	Drug: INS018_055; Pharmaceutical formulation: Capsules Mode of Administration: Oral
Experimental: INS018_055 60 mg QD; Group 3: INS018_055 once daily up to 12 weeks, high dose	Drug: INS018_055; Pharmaceutical formulation: Capsules Mode of Administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)	TEAEs were either events with start date on or after the start of the Treatment Period and up to 17 days after EOT (end of treatment), or events with start date prior to the start of the Treatment Period whose severity worsened on or after the start of the Treatment Period and up to 17 days after EOT. CTCAE=Common Terminology Criteria for Adverse Events	From first dose of study drug until end of study (EOS) visit i.e. up to 13 weeks (+10 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative Change From Baseline in Forced Vital Capacity (FVC)	Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.	Week 0/Visit 2 up to Week 12
Absolute Change From Baseline in FVC in L	Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.	Week 0/Visit 2 up to Week 12
Absolute Change in FVC % Predicted	Absolute change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment	Week 0/Visit 2 up to Week 12
Relative Change in FVC % Predicted	Relative change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment	Week 0/Visit 2 up to Week 12

Collaborators and Investigators

• Sponsor: InSilico Medicine Hong Kong Limited

Publications and helpful links

General Publications

• Xu Z, Ren F, Wang P, Cao J, Tan C, Ma D, Zhao L, Dai J, Ding Y, Fang H, Li H, Liu H, Luo F, Meng Y, Pan P, Xiang P, Xiao Z, Rao S, Satler C, Liu S, Lv Y, Zhao H, Chen S, Cui H, Korzinkin M, Gennert D, Zhavoronkov A. A generative AI-discovered TNIK inhibitor for idiopathic pulmonary fibrosis: a randomized phase 2a trial. Nat Med. 2025 Aug;31(8):2602-2610. doi: 10.1038/s41591-025-03743-2. Epub 2025 Jun 3.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Actual): August 8, 2024
• Study Completion (Actual): August 8, 2024

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Fibrosis; Respiratory Tract Diseases; Pathologic Processes; Lung Diseases; Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Lung Diseases, Interstitial
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Lung Diseases, Interstitial; Respiratory Tract Diseases; Pathologic Processes
• Other Study ID Numbers: INS018-055-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No