Phase 2
N=71
Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis (IPF)
Bottom Line
View on ClinicalTrials.gov: NCT05938920 ↗Enrolled (actual)
71
Serious AEs
22.5%
Results posted
Dec 2025
Primary outcome: Primary: Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE) — 13; 15; 15; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- INS018_055 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- InSilico Medicine Hong Kong Limited
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE) |
13; 15; 15; 12; 3; 7 | — |
| SECONDARY Relative Change From Baseline in Forced Vital Capacity (FVC) |
-0.7923; 0.6821; 3.2253; -0.7126 | — |
| SECONDARY Absolute Change From Baseline in FVC in L |
-0.0270; 0.0197; 0.0984; -0.0203 | — |
| SECONDARY Absolute Change in FVC % Predicted |
-0.6729; 0.6455; 3.0461; -0.5675 | — |
| SECONDARY Relative Change in FVC % Predicted |
-0.6724; 0.4434; 3.2194; -0.8414 | — |
Summary
The goal of this clinical trial is to learn about INS018\_055 in adults with Idiopathic Pulmonary Fibrosis (IPF).
The primary objective is to evaluate the safety and tolerability of INS018\_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo.
Eligibility Criteria
Inclusion Criteria
- Male or female patients aged ≥40 years based on the date of the written informed consent form
- Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
- 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
- Subjects with background pirfenidone or nintedanib may be enrolled if their regimen of antifibrotic therapy has been stable for > 8 weeks prior to Visit 1
- Meeting all of the following criteria during the screening period:
- FVC ≥40% predicted of normal
- DLCO corrected for Hgb ≥25% and 0.7 based on pre-bronchodilator value
Exclusion Criteria
- Acute IPF exacerbation within 4 months prior to Visit 1 and/or during the screening period, as determined by the investigator
- Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
- Female patients who are pregnant or nursing
- Abnormal ECG findings
Other protocol inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05938920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.