Completed

NCT Number: NCT05938920

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)

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.

Completed

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Key information

Conditions

Idiopathic Pulmonary Fibrosis (IPF) Fibrosis Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anhui Chest Hospital, Hefei, Anhui, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 <80% predicted of normal.
forced expiratory volume in the first second/FVC (FEV1/FVC) ratio >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.

Treatment and study plan

INS018_055

Drug

Pharmaceutical formulation: Capsules

Mode of Administration: Oral

Placebo

Drug

Pharmaceutical formulation: Capsules

Mode of Administration: Oral

Primary outcomes

Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)

Time frame: From first dose of study drug until end of study (EOS) visit i.e. up to 13 weeks (+10 days)

TEAEs were either events with start date on or after the start of the Treatment Period and up to 17 days after EOT (end of treatment), or events with start date prior to the start of the Treatment Period whose severity worsened on or after the start of the Treatment Period and up to 17 days after EOT.

CTCAE=Common Terminology Criteria for Adverse Events

Secondary outcomes

Relative Change From Baseline in Forced Vital Capacity (FVC)

Time frame: Week 0/Visit 2 up to Week 12

Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.
Absolute Change From Baseline in FVC in L

Time frame: Week 0/Visit 2 up to Week 12

Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.
Absolute Change in FVC % Predicted

Time frame: Week 0/Visit 2 up to Week 12

Absolute change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment
Relative Change in FVC % Predicted

Time frame: Week 0/Visit 2 up to Week 12

Relative change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment

Sponsors and collaborators

Lead sponsor

InSilico Medicine Hong Kong Limited

Industry

Registry information

Official study title

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)

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jul 11, 2023
Registry last updated: Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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