Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

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)

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).

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Intervention / Treatment: Drug: INS018_055; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Monique Duncan; Phone Number: +86 18817554306; Email: Insilico-Clinicaltrial@insilico.ai
• Study Contact Backup: Name: Carol Salter, MD, PhD; Email: Insilico-Clinicaltrial@insilico.ai

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Recruiting
      • HonorHealth Research Institute
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Keck School of Medicine of USC
  • Florida
    • Celebration, Florida, United States, 34747-1818
      • Recruiting
      • Florida Lung Asthma and Sleep Specialist
    • Orlando, Florida, United States, 32803-5727
      • Recruiting
      • Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103-4007
      • Recruiting
      • Southeastern Research Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104-5417
      • Recruiting
      • University of Oklahoma Health Sciences Center (OUHSC)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University Hospital-Temple Lung Center
  • South Carolina
    • Columbia, South Carolina, United States, 29201-2953
      • Recruiting
      • Bogan Sleep Consultants, LLC
  • Texas
    • Dallas, Texas, United States, 75235-6243
      • Recruiting
      • University of Texas Southwestern Medical Center
    • McKinney, Texas, United States, 75071
      • Recruiting
      • Research Centers of America
    • McKinney, Texas, United States, 75069-1898
      • Recruiting
      • Metroplex Pulmonary and Sleep Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INS018_055; INS018_055 is administered once daily up to 12 weeks	Drug: INS018_055; Pharmaceutical formulation: Tablet Mode of Administration: Oral
Placebo Comparator: Placebo; Placebo is administered once daily up to 12 weeks	Drug: Placebo; Pharmaceutical formulation: Tablet Mode of Administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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))

Collaborators and Investigators

• Sponsor: InSilico Medicine Hong Kong Limited

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Fibrosis; Respiratory Tract Diseases; Pathologic Processes; Lung Diseases; Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Lung Diseases, Interstitial
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Lung Diseases, Interstitial; Respiratory Tract Diseases; Pathologic Processes
• Other Study ID Numbers: INS018-055-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No