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)
InSilico Medicine Hong Kong Limited
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).
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).
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugINS018_055
Pharmaceutical formulation: Tablet Mode of Administration: Oral
- DrugPlacebo
Pharmaceutical formulation: Tablet Mode of Administration: Oral
Locations (12)
- University of Alabama at BirminghamBirmingham, Alabama
- HonorHealth Research InstituteScottsdale, Arizona
- Keck School of Medicine of USCLos Angeles, California
- Florida Lung Asthma and Sleep SpecialistCelebration, Florida
- Central Florida Pulmonary Group, P.A. (CFPG) - Downtown OrlandoOrlando, Florida
- Southeastern Research CenterWinston-Salem, North Carolina