A Phase 2 interventional study of INS018_055 and Placebo in Idiopathic Pulmonary Fibrosis (IPF), sponsored by InSilico Medicine Hong Kong Limited. Recruiting at 12 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-11-12.
Sponsored by InSilico Medicine Hong Kong Limited · Phase 2, Interventional, and Treatment
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).
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).
Meeting all of the following criteria during the screening period:
Exclusion Criteria:
INS018\_055 is administered once daily up to 12 weeks
Drug: INS018_055
Placebo is administered once daily up to 12 weeks
Drug: Placebo
Pharmaceutical formulation: Tablet Mode of Administration: Oral
Pharmaceutical formulation: Tablet Mode of Administration: Oral
Percentage of subjects who have at least 1 treatment-emergent adverse event (TEAE)
Time frame: Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT))
Maximum plasma concentration (Cmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Week 0/Visit 2 up to Week 12
Percentage change in FVC in mL
Time frame: Week 0/Visit 2 up to Week 12
Absolute and relative change in FVC % predicted
Time frame: Week 0/Visit 2 up to Week 12
Change in Diffusion Capacity of the lung for Carbon Monoxide (DLCO) % predicted
Time frame: Week 0/Visit 2 to Week 12
Change in Leicester Cough Questionnaire (LCQ)
Time frame: Week 0 to Week 4, 8 and 12
Change in 6-Minute Walk Distance (6MWD) in meters
Time frame: Week 0 to Week 12
Number of acute IPF exacerbations
Time frame: Week 0 up to Week 12
Number of days hospitalized for acute IPF exacerbations
Time frame: Week 0 to up Week 12
Plan to share: No
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Idiopathic Pulmonary Fibrosis→
InSilico Medicine Hong Kong Limited