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Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT05975983

Recruitment Status : Recruiting

First Posted : August 4, 2023

Last Update Posted : April 11, 2024

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

InSilico Medicine Hong Kong Limited

Tracking Information

First Submitted Date ^ICMJE

July 27, 2023

First Posted Date ^ICMJE

August 4, 2023

Last Update Posted Date

April 11, 2024

Actual Study Start Date ^ICMJE

February 8, 2024

Estimated Primary Completion Date

February 28, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)) ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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)) ]
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)) ]
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)) ]
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)) ]
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)) ]
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)) ]
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)) ]
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)) ]
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)) ]
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)) ]
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)) ]
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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Official Title ^ICMJE

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)

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Idiopathic Pulmonary Fibrosis (IPF)

Intervention ^ICMJE

Drug: INS018_055
Pharmaceutical formulation: Capsules

Mode of Administration: Oral
Drug: Placebo
Pharmaceutical formulation: Capsules

Mode of Administration: Oral

Study Arms ^ICMJE

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

Intervention: Drug: INS018_055
Placebo Comparator: Placebo
Group 4: Placebo once or twice daily up to 12 weeks

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

February 28, 2026

Estimated Primary Completion Date

February 28, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

40 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Yichen Liu	+86 18817554306	Insilico-Clinicaltrial@insilico.ai
Contact: Franz Espiritu		franz@insilicomedicine.com

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05975983

Other Study ID Numbers ^ICMJE

INS018-055-004

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Current Responsible Party

InSilico Medicine Hong Kong Limited

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

InSilico Medicine Hong Kong Limited

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

InSilico Medicine Hong Kong Limited

Verification Date

April 2024

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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