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Trial record 2 of 4 for:    Insilico Medicine
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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
Sponsor:
Information provided by (Responsible Party):
InSilico Medicine Hong Kong Limited

Study Description
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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.


Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis (IPF) Drug: INS018_055 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 8, 2024
Estimated Primary Completion Date : February 28, 2026
Estimated Study Completion Date : February 28, 2026

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Arms and Interventions
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Arm Intervention/treatment
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
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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 Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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:

  1. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05975983


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

Locations
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United States, California
Keck School of Medicine of USC Not yet recruiting
Los Angeles, California, United States, 90033
United States, Florida
Florida Lung Asthma and Sleep Specialist Recruiting
Celebration, Florida, United States, 34747-1818
United States, North Carolina
Southeastern Research Center Recruiting
Winston-Salem, North Carolina, United States, 27103-4007
United States, Oklahoma
University of Oklahoma Health Sciences Center (OUHSC) Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104-5417
United States, South Carolina
Bogan Sleep Consultants, LLC Recruiting
Columbia, South Carolina, United States, 29201-2953
United States, Texas
Univerity of Texas Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75235-6243
Metroplex Pulmonary and Sleep Center Recruiting
McKinney, Texas, United States, 75069-1898
Research Centers of America Not yet recruiting
McKinney, Texas, United States, 75071
Sponsors and Collaborators
InSilico Medicine Hong Kong Limited
More Information
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Responsible Party: InSilico Medicine Hong Kong Limited
ClinicalTrials.gov Identifier: NCT05975983    
Other Study ID Numbers: INS018-055-004
First Posted: August 4, 2023    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by InSilico Medicine Hong Kong Limited:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases