Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)
NCT ID: NCT05938920
Last Updated: 2025-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
71 participants
INTERVENTIONAL
2023-06-19
2024-08-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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INS018_055 30 mg QD
Group 1: INS018\_055 once daily up to 12 weeks, low dose
INS018_055
Pharmaceutical formulation: Capsules
Mode of Administration: Oral
INS018_055 30 mg BID
Group 2: INS018\_055 twice daily up to 12 weeks, low dose
INS018_055
Pharmaceutical formulation: Capsules
Mode of Administration: Oral
INS018_055 60 mg QD
Group 3: INS018\_055 once daily up to 12 weeks, high dose
INS018_055
Pharmaceutical formulation: Capsules
Mode of Administration: Oral
Placebo
Group 4: Placebo once or twice daily up to 12 weeks
Placebo
Pharmaceutical formulation: Capsules
Mode of Administration: Oral
Interventions
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INS018_055
Pharmaceutical formulation: Capsules
Mode of Administration: Oral
Placebo
Pharmaceutical formulation: Capsules
Mode of Administration: Oral
Eligibility Criteria
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Inclusion Criteria
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
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
40 Years
ALL
No
Sponsors
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InSilico Medicine Hong Kong Limited
INDUSTRY
Responsible Party
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Locations
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Anhui Chest Hospital
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Hainan General Hospital
Haikou, Hainan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The Shengjing Hospital of China medical university
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Zhongshan hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
The West China Hospital of Sichuan University
Chengdu, Sichuan, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INS018-055-003
Identifier Type: -
Identifier Source: org_study_id
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