NCT05975983

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: InSilico Medicine Hong Kong Limited · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Idiopathic Pulmonary Fibrosis (IPF)

Interventions

Type	Name	Description
DRUG	INS018_055	Pharmaceutical formulation: Tablet Mode of Administration: Oral
DRUG	Placebo	Pharmaceutical formulation: Tablet Mode of Administration: Oral

Timeline

• Start date: 2024-02-08
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2023-08-04
• Last updated: 2025-11-12

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study