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

Phase 2

Active, not recruiting

• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Interventions: Drug: Placebo; Drug: INS018_055

• Registration Number: NCT05938920
• Lead Sponsor: InSilico Medicine Hong Kong Limited

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study Start: 2023-06-19
• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-16
• Last Update Posted: 2024-06-18
• Primary Completion: 2024-08-23
• Study Completion: 2024-08-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Group 4: Placebo once or twice daily up to 12 weeks
INS018_055	INS018_055	Group 1: INS018_055 once daily up to 12 weeks, low dose Group 2: INS018_055 twice daily up to 12 weeks, low dose Group 3: INS018_055 once daily up to 12 weeks, high dose

Primary Outcome Measures

Name	Time	Method
Percentage of patients who have at least 1 treatment-emergent adverse event (TEAE)	Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT))

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve from time zero to dosing interval τ (AUC0-τ) of INS018_055 and metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of INS018_055 and metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
Maximum plasma concentration (Cmax) of INS018_055 and metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
Accumulation ratio (Rac) for Cmax and AUC of INS018_055 and metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
Trough plasma concentration (Ctrough) of INS018_055 and metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
Relative change in Forced Vital Capacity (FVC) in mL	Week 0/Visit 2 up to Week 12
Percentage change in FVC in mL	Week 0/Visit 2 up to Week 12
Absolute and relative change in FVC % predicted	Week 0/Visit 2 up to Week 12
Number of days hospitalized for acute IPF exacerbations	Week 0 to up Week 12
Time at which the maximum plasma concentration occurred (tmax) of INS018_055 and metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
Terminal elimination rate constant (λz) of INS018_055 and metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
Area under the plasma concentration-time curve from time zero to infinity (∞) (AUC0-∞) of INS018_055 and metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
Terminal elimination half-life (t1/2) of INS018_055 and metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
Change in Leicester Cough Questionnaire (LCQ)	Week 0 to Week 4, 8 and 12
Change in 6-Minute Walk Distance (6MWD) in meters	Week 0 to Week 12
Apparent clearance (CL/F) of INS018_055 and metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
Apparent volume of distribution (Vz/F) of INS018_055 and metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
Change in Diffusion Capacity of the lung for Carbon Monoxide (DLCO) % predicted	Week 0/Visit 2 to Week 12
Number of acute IPF exacerbations	Week 0 up to Week 12

Trial Locations

Locations (22)

Anhui Chest Hospital; 🇨🇳 Hefei, Anhui, China

The Second Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Peking University Shougang Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Hainan General Hoapital; 🇨🇳 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

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Jiangxi Provincial People's Hospital; 🇨🇳 Nanchang, Jiangxi, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

The Shengjing Hospital of China medical university; 🇨🇳 Shenyang, Liaoning, China

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China

Zhongshan hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China

Shanxi Bethune Hospital; 🇨🇳 Taiyuan, Shanxi, China

The West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China

General Hospital of Tianjin Medical University; 🇨🇳 Tianjin, Tianjin, China

The First Affiliated Hospital - Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China