Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Phase 2

Recruiting

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

• Registration Number: NCT05975983
• Lead Sponsor: InSilico Medicine Hong Kong Limited

Brief Summary

The purpose of this revised Phase IIa study is to demonstrate safety of INS018\_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF).

Detailed Description

Idiopathic pulmonary fibrosis is a fatal lung disease characterized by reduced quality of life (QoL) and a median survival of 3 to 4 years. While current standard of care (SoC) treatments including pirfenidone and nintedanib slow disease progression, they are not curative and poorly tolerated due to their toxicity profiles. To address the need for new treatments in IPF, InSilico Medicine is developing INS018\_055, a potent inhibitor of the serine/threonine kinase Traf2- and Nckinteracting kinase (TNIK).

Study Timeline

• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-07-27
• Study First Posted: 2023-08-04
• Study Start: 2024-02-08
• Status Verified: 2025-11
• Last Update Submitted: 2025-11-10
• Last Update Posted: 2025-11-12
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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. Meeting all of the following criteria during the screening period:

   1. FVC ≥40% predicted normal
   2. DLCO corrected for Hgb ≥25% and <80% predicted 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 Day 1, 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INS018_055	INS018_055	INS018\_055 is administered once daily up to 12 weeks
Placebo	Placebo	Placebo is administered once daily up to 12 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of subjects 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
Maximum plasma concentration (Cmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))
Time to reach maximum plasma concentration (Tmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))
Area under the plasma concentration-time curve from time zero to dosing interval τ (AUC0-τ) of INS018_055 and its major metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, 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 its major metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))
Area under the plasma concentration-time curve from time zero to infinity (∞) (AUC0-∞) of INS018_055 and its major metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))
Terminal elimination half-life (t1/2) of INS018_055 and its major metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))
Terminal elimination rate constant (λz) of INS018_055 and its major metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))
Apparent clearance (CL/F) of INS018_055 and its major metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))
Apparent volume of distribution (Vz/F) of INS018_055 and its major metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))
Accumulation ratio (Rac) for Cmax and AUC of INS018_055 and its major metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))
Trough plasma concentration (Ctrough) of INS018_055 and its major metabolites (INS018_063 and INS018_095)	Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, 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

Trial Locations

Locations (12)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

HonorHealth Research Institute; 🇺🇸 Scottsdale, Arizona, United States

Keck School of Medicine of USC; 🇺🇸 Los Angeles, California, United States

Florida Lung Asthma and Sleep Specialist; 🇺🇸 Celebration, Florida, United States

Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando; 🇺🇸 Orlando, Florida, United States

Southeastern Research Center; 🇺🇸 Winston-Salem, North Carolina, United States

University of Oklahoma Health Sciences Center (OUHSC); 🇺🇸 Oklahoma City, Oklahoma, United States

Temple University Hospital-Temple Lung Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Bogan Sleep Consultants, LLC; 🇺🇸 Columbia, South Carolina, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

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