History of Changes for Study: NCT05975983

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

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Study Record Versions

Version	Submitted Date	Changes
1	July 27, 2023	None (earliest Version on record)
2	August 21, 2023	Study Status and Eligibility
3	December 18, 2023	Recruitment Status, Study Status and Contacts/Locations
4	January 11, 2024	Study Status and Contacts/Locations
5	April 9, 2024	Study Status and Eligibility

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	INS018-055-004
Brief Title:	Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis
Official 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)
Secondary IDs:

Study Status


Record Verification:	July 2023
Overall Status:	Not yet recruiting
Study Start:	October 1, 2023
Primary Completion:	February 28, 2026 [Anticipated]
Study Completion:	February 28, 2026 [Anticipated]

First Submitted:	July 27, 2023
First Submitted that Met QC Criteria:	July 27, 2023
First Posted:	August 4, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	July 27, 2023
Last Update Posted:	August 4, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	InSilico Medicine Hong Kong Limited
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

Brief 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.

Detailed Description:

Conditions


Conditions:	Idiopathic Pulmonary Fibrosis (IPF)
Keywords:	Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	60 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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

Outcome Measures


Primary Outcome Measures:
1.	Percentage of patients who have at least 1 treatment-emergent adverse event (TEAE) [ Time Frame: Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT)) ]
Secondary Outcome Measures:
1.	Maximum plasma concentration (Cmax) of INS018_055 and 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 6, End of Treatment (EOT)) ]
2.	Time at which the maximum plasma concentration occurred (tmax) of INS018_055 and 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 6, End of Treatment (EOT)) ]
3.	Area under the plasma concentration-time curve from time zero to dosing interval τ (AUC0-τ) of INS018_055 and 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 6, End of Treatment (EOT)) ]
4.	Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of INS018_055 and 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 6, End of Treatment (EOT)) ]
5.	Area under the plasma concentration-time curve from time zero to infinity (∞) (AUC0-∞) of INS018_055 and 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 6, End of Treatment (EOT)) ]
6.	Terminal elimination half-life (t1/2) of INS018_055 and 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 6, End of Treatment (EOT)) ]
7.	Terminal elimination rate constant (λz) of INS018_055 and 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 6, End of Treatment (EOT)) ]
8.	Apparent clearance (CL/F) of INS018_055 and 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 6, End of Treatment (EOT)) ]
9.	Apparent volume of distribution (Vz/F) of INS018_055 and 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 6, End of Treatment (EOT)) ]
10.	Accumulation ratio (Rac) for Cmax and AUC of INS018_055 and 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 6, End of Treatment (EOT)) ]
11.	Trough plasma concentration (Ctrough) of INS018_055 and 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 6, End of Treatment (EOT)) ]
12.	Relative change in Forced Vital Capacity (FVC) in mL [ Time Frame: Week 0/Visit 2 up to Week 12 ]
13.	Percentage change in FVC in mL [ Time Frame: Week 0/Visit 2 up to Week 12 ]
14.	Absolute and relative change in FVC % predicted [ Time Frame: Week 0/Visit 2 up to Week 12 ]
15.	Change in Diffusion Capacity of the lung for Carbon Monoxide (DLCO) % predicted [ Time Frame: Week 0/Visit 2 to Week 12 ]
16.	Change in Leicester Cough Questionnaire (LCQ) [ Time Frame: Week 0 to Week 4, 8 and 12 ]
17.	Change in 6-Minute Walk Distance (6MWD) in meters [ Time Frame: Week 0 to Week 12 ]
18.	Number of acute IPF exacerbations [ Time Frame: Week 0 up to Week 12 ]
19.	Number of days hospitalized for acute IPF exacerbations [ Time Frame: Week 0 to up Week 12 ]

Eligibility


Minimum Age:	40 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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 ≤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 Day 1, 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

Contacts/Locations


Central Contact Person:	Yichen Liu Telephone: +86 18817554306 Email: Insilico-Clinicaltrial@insilico.ai
Central Contact Backup:	Franz Espiritu Email: franz@insilicomedicine.com
Locations:	United States, California
	Keck School of Medicine of USC Los Angeles, California, United States, 90033
	United States, Florida
	Florida Lung Asthma and Sleep Specialist Celebration, Florida, United States, 34747-1818
	United States, North Carolina
	Southeastern Research Center Winston-Salem, North Carolina, United States, 27103-4007
	United States, Oklahoma
	University of Oklahoma Health Sciences Center (OUHSC) Oklahoma City, Oklahoma, United States, 73104-5417
	United States, South Carolina
	Bogan Sleep Consultants, LLC Columbia, South Carolina, United States, 29201-2953
	United States, Texas
	Univerity of Texas Southwestern Medical Center Dallas, Texas, United States, 75235-6243
	Metroplex Pulmonary and Sleep Center McKinney, Texas, United States, 75069-1898
	Research Centers of America McKinney, Texas, United States, 75071
	United States, Utah
	University of Utah, University Hospital Salt Lake City, Utah, United States, 84132

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: