Trials Today

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Purpose

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).

Condition

Idiopathic Pulmonary Fibrosis (IPF)

Eligibility

Eligible Ages: Over 40 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
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

Recruiting Locations

University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35294

HonorHealth Research Institute
Scottsdale 5313457, Arizona 5551752 85258

Keck School of Medicine of USC
Los Angeles 5368361, California 5332921 90033

Florida Lung Asthma and Sleep Specialist
Celebration 4150394, Florida 4155751 34747-1818

Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando
Orlando 4167147, Florida 4155751 32803-5727

Southeastern Research Center
Winston-Salem 4499612, North Carolina 4482348 27103-4007

University of Oklahoma Health Sciences Center (OUHSC)
Oklahoma City 4544349, Oklahoma 4544379 73104-5417

Temple University Hospital-Temple Lung Center
Philadelphia 4560349, Pennsylvania 6254927 19140

Bogan Sleep Consultants, LLC
Columbia 4575352, South Carolina 4597040 29201-2953

University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75235-6243

Metroplex Pulmonary and Sleep Center
McKinney 4710178, Texas 4736286 75069-1898

Research Centers of America
McKinney 4710178, Texas 4736286 75071

More Details

NCT ID: NCT05975983
Status: Recruiting
Sponsor: InSilico Medicine Hong Kong Limited

Study Contact

Monique Duncan
+86 18817554306
Insilico-Clinicaltrial@insilico.ai

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).