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Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Purpose

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.

Condition

Idiopathic Pulmonary Fibrosis (IPF)

Eligibility

Eligible Ages: Over 40 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Male or female patients aged ≥40 years based on the date of the written informed consent form 2. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines 3. 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 4. 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: 1. FVC ≥40% predicted of normal 2. DLCO corrected for Hgb ≥25% and <80% predicted of normal. 3. 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 Day 1, as determined by the investigator 2. Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study 3. Female patients who are pregnant or nursing 4. Abnormal ECG findings

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental INS018_055	Group 1: INS018_055 once daily up to 12 weeks, low dose Group 2: INS018_055 twice daily up to 12 weeks, low dose Group 3: INS018_055 once daily up to 12 weeks, high dose	Drug: INS018_055 Pharmaceutical formulation: Capsules Mode of Administration: Oral
Placebo Comparator Placebo	Group 4: Placebo once or twice daily up to 12 weeks	Drug: Placebo Pharmaceutical formulation: Capsules Mode of Administration: Oral

Recruiting Locations

Florida Lung Asthma and Sleep Specialist
Celebration, Florida 34747-1818

Southeastern Research Center
Winston-Salem, North Carolina 27103-4007

Bogan Sleep Consultants, LLC
Columbia, South Carolina 29201-2953

Metroplex Pulmonary and Sleep Center
McKinney, Texas 75069-1898

More Details

NCT ID: NCT05975983
Status: Recruiting
Sponsor: InSilico Medicine Hong Kong Limited

Study Contact

Yichen Liu
+86 18817554306
Insilico-Clinicaltrial@insilico.ai

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.