Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Sponsor

InSilico Medicine Hong Kong Limited (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05975983

Collaborator

(none)

Enrollment

Locations

Arms

28.9

Anticipated Duration (Months)

6.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis (IPF)	Drug: INS018_055 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Feb 28, 2026

Anticipated Study Completion Date :

Feb 28, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: INS018_055 Pharmaceutical formulation: Capsules Mode of Administration: Oral
Placebo Comparator: Placebo Group 4: Placebo once or twice daily up to 12 weeks	Drug: Placebo Pharmaceutical formulation: Capsules Mode of Administration: Oral

Arm

Intervention/Treatment

Experimental: 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

Drug: INS018_055

Pharmaceutical formulation: Capsules Mode of Administration: Oral

Placebo Comparator: Placebo

Group 4: Placebo once or twice daily up to 12 weeks

Drug: Placebo

Pharmaceutical formulation: Capsules Mode of Administration: Oral

Outcome Measures

Primary Outcome Measures

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

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))]
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))]
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))]
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))]
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))]
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))]
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]
Change in Diffusion Capacity of the lung for Carbon Monoxide (DLCO) % predicted [Week 0/Visit 2 to Week 12]
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]
Number of acute IPF exacerbations [Week 0 up to Week 12]
Number of days hospitalized for acute IPF exacerbations [Week 0 to up Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keck School of Medicine of USC	Los Angeles	California	United States	90033
2	Florida Lung Asthma and Sleep Specialist	Celebration	Florida	United States	34747-1818
3	Southeastern Research Center	Winston-Salem	North Carolina	United States	27103-4007
4	University of Oklahoma Health Sciences Center (OUHSC)	Oklahoma City	Oklahoma	United States	73104-5417
5	Bogan Sleep Consultants, LLC	Columbia	South Carolina	United States	29201-2953
6	Univerity of Texas Southwestern Medical Center	Dallas	Texas	United States	75235-6243
7	Metroplex Pulmonary and Sleep Center	McKinney	Texas	United States	75069-1898
8	Research Centers of America	McKinney	Texas	United States	75071
9	University of Utah, University Hospital	Salt Lake City	Utah	United States	84132