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

Idiopathic Pulmonary Fibrosis (IPF) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05938920
• Other study ID #: INS018-055-003
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 19, 2023
• Est. completion date: August 23, 2024

Study information

• Verified date: June 2024
• Source: InSilico Medicine Hong Kong Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: August 23, 2024
• Est. primary completion date: August 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Idiopathic Pulmonary Fibrosis (IPF)
• Pulmonary Fibrosis

Intervention

Drug:
• INS018_055
Pharmaceutical formulation: Capsules Mode of Administration: Oral
• Placebo
Pharmaceutical formulation: Capsules Mode of Administration: Oral

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking University Shougang Hospital	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	The West China Hospital of Sichuan University	Chengdu	Sichuan
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 - Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Anhui Chest Hospital	Hefei	Anhui
China	The Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	Zhongshan hospital Fudan University	Shanghai	Shanghai
China	The Shengjing Hospital of China medical university	Shenyang	Liaoning
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	General Hospital of Tianjin Medical University	Tianjin	Tianjin
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
InSilico Medicine Hong Kong Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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))
Secondary	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))
Secondary	Area under the plasma concentration-time curve from time zero to dosing interval 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))
Secondary	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))
Secondary	Area under the plasma concentration-time curve from time zero to infinity (8) (AUC0-8) 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))
Secondary	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))
Secondary	Terminal elimination rate constant (?z) 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))
Secondary	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))
Secondary	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))
Secondary	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))
Secondary	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))
Secondary	Relative change in Forced Vital Capacity (FVC) in mL		Week 0/Visit 2 up to Week 12
Secondary	Percentage change in FVC in mL		Week 0/Visit 2 up to Week 12
Secondary	Absolute and relative change in FVC % predicted		Week 0/Visit 2 up to Week 12
Secondary	Change in Diffusion Capacity of the lung for Carbon Monoxide (DLCO) % predicted		Week 0/Visit 2 to Week 12
Secondary	Change in Leicester Cough Questionnaire (LCQ)		Week 0 to Week 4, 8 and 12
Secondary	Change in 6-Minute Walk Distance (6MWD) in meters		Week 0 to Week 12
Secondary	Number of acute IPF exacerbations		Week 0 up to Week 12
Secondary	Number of days hospitalized for acute IPF exacerbations		Week 0 to up Week 12