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)
1 other identifier
interventional
71
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2023
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2023
CompletedFirst Submitted
Initial submission to the registry
June 28, 2023
CompletedFirst Posted
Study publicly available on registry
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2024
CompletedResults Posted
Study results publicly available
December 2, 2025
CompletedDecember 11, 2025
December 1, 2025
1.1 years
June 28, 2023
September 29, 2025
December 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Relative Change From Baseline in Forced Vital Capacity (FVC)
Week 0/Visit 2 up to Week 12
Absolute Change From Baseline in FVC in L
Week 0/Visit 2 up to Week 12
Absolute Change in FVC % Predicted
Week 0/Visit 2 up to Week 12
Relative Change in FVC % Predicted
Week 0/Visit 2 up to Week 12
Study Arms (4)
INS018_055 30 mg QD
EXPERIMENTALGroup 1: INS018\_055 once daily up to 12 weeks, low dose
INS018_055 30 mg BID
EXPERIMENTALGroup 2: INS018\_055 twice daily up to 12 weeks, low dose
INS018_055 60 mg QD
EXPERIMENTALGroup 3: INS018\_055 once daily up to 12 weeks, high dose
Placebo
PLACEBO COMPARATORGroup 4: Placebo once or twice daily up to 12 weeks
Interventions
Pharmaceutical formulation: Capsules Mode of Administration: Oral
Eligibility Criteria
You may qualify if:
- Male or female patients aged ≥40 years based on the date of the written informed consent form
- Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
- 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
- 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
- Meeting all of the following criteria during the screening period:
- FVC ≥40% predicted of normal
- DLCO corrected for Hgb ≥25% and \<80% predicted of normal.
- forced expiratory volume in the first second/FVC (FEV1/FVC) ratio \>0.7 based on pre-bronchodilator value
You may not qualify if:
- Acute IPF exacerbation within 4 months prior to Visit 1 and/or during the screening period, as determined by the investigator
- Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
- Female patients who are pregnant or nursing
- Abnormal ECG findings
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Anhui Chest Hospital
Hefei, Anhui, 230031, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100041, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Hainan General Hospital
Haikou, Hainan, 570311, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
The Shengjing Hospital of China medical university
Shenyang, Liaoning, 110004, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250013, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Zhongshan hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 201800, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
The West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300052, China
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006, China
Related Publications (1)
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.
PMID: 40461817DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Yujin Tian
- Organization
- InSilico Medicine Hong Kong Limited
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2023
First Posted
July 11, 2023
Study Start
June 19, 2023
Primary Completion
August 8, 2024
Study Completion
August 8, 2024
Last Updated
December 11, 2025
Results First Posted
December 2, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share