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).
576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.
This study's planned enrollment of 40 is below the median of 55 across 389 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →InSilico Medicine Hong Kong Limited is the lead sponsor of 11 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meeting all of the following criteria during the screening period:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Feb 2026, 24 months after the start.
Of 63 industry-sponsored phase 2 interventional studies under Idiopathic Pulmonary Fibrosis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 48. This study's planned 24 months is close to that.
Counting every sponsor, half of 76 studies reached it within 30 months; a quarter within 21 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Rentosertib
Idiopathic Pulmonary Fibrosis →
InSilico Medicine Hong Kong Limited