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The purpose of this revised Phase IIa study is to demonstrate safety of INS018_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF).
Idiopathic pulmonary fibrosis is a fatal lung disease characterized by reduced quality of life (QoL) and a median survival of 3 to 4 years. While current standard of care (SoC) treatments including pirfenidone and nintedanib slow disease progression, they are not curative and poorly tolerated due to their toxicity profiles. To address the need for new treatments in IPF, InSilico Medicine is developing INS018_055, a potent inhibitor of the serine/threonine kinase Traf2- and Nckinteracting kinase (TNIK).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INS018_055 | Experimental | INS018_055 is administered once daily up to 12 weeks |
|
| Placebo | Placebo Comparator | Placebo is administered once daily up to 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INS018_055 | Drug | Pharmaceutical formulation: Tablet Mode of Administration: Oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who have at least 1 treatment-emergent adverse event (TEAE) | Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT)) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095) | Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)) | |
| Time to reach maximum plasma concentration (Tmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095) |
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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
Meeting all of the following criteria during the screening period:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monique Duncan | Contact | +86 18817554306 | Insilico-Clinicaltrial@insilico.ai | |
| Carol Salter, MD, PhD | Contact | Insilico-Clinicaltrial@insilico.ai |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States | |
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| Placebo |
| Drug |
Pharmaceutical formulation: Tablet Mode of Administration: Oral |
|
| Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)) |
| Area under the plasma concentration-time curve from time zero to dosing interval τ (AUC0-τ) of INS018_055 and its major metabolites (INS018_063 and INS018_095) | Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, 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 its major metabolites (INS018_063 and INS018_095) | Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)) |
| Area under the plasma concentration-time curve from time zero to infinity (∞) (AUC0-∞) of INS018_055 and its major metabolites (INS018_063 and INS018_095) | Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)) |
| Terminal elimination half-life (t1/2) of INS018_055 and its major metabolites (INS018_063 and INS018_095) | Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)) |
| Terminal elimination rate constant (λz) of INS018_055 and its major metabolites (INS018_063 and INS018_095) | Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)) |
| Apparent clearance (CL/F) of INS018_055 and its major metabolites (INS018_063 and INS018_095) | Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)) |
| Apparent volume of distribution (Vz/F) of INS018_055 and its major metabolites (INS018_063 and INS018_095) | Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)) |
| Accumulation ratio (Rac) for Cmax and AUC of INS018_055 and its major metabolites (INS018_063 and INS018_095) | Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)) |
| Trough plasma concentration (Ctrough) of INS018_055 and its major metabolites (INS018_063 and INS018_095) | Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT)) |
| Relative change in Forced Vital Capacity (FVC) in mL | Week 0/Visit 2 up to Week 12 |
| Percentage change in FVC in mL | Week 0/Visit 2 up to Week 12 |
| Absolute and relative change in FVC % predicted | Week 0/Visit 2 up to Week 12 |
| Change in Diffusion Capacity of the lung for Carbon Monoxide (DLCO) % predicted | Week 0/Visit 2 to Week 12 |
| Change in Leicester Cough Questionnaire (LCQ) | Week 0 to Week 4, 8 and 12 |
| Change in 6-Minute Walk Distance (6MWD) in meters | Week 0 to Week 12 |
| Number of acute IPF exacerbations | Week 0 up to Week 12 |
| Number of days hospitalized for acute IPF exacerbations | Week 0 to up Week 12 |
| HonorHealth Research Institute |
| Recruiting |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Keck School of Medicine of USC | Recruiting | Los Angeles | California | 90033 | United States |
| Florida Lung Asthma and Sleep Specialist | Recruiting | Celebration | Florida | 34747-1818 | United States |
| Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando | Recruiting | Orlando | Florida | 32803-5727 | United States |
| Southeastern Research Center | Recruiting | Winston-Salem | North Carolina | 27103-4007 | United States |
| University of Oklahoma Health Sciences Center (OUHSC) | Recruiting | Oklahoma City | Oklahoma | 73104-5417 | United States |
| Temple University Hospital-Temple Lung Center | Recruiting | Philadelphia | Pennsylvania | 19140 | United States |
| Bogan Sleep Consultants, LLC | Recruiting | Columbia | South Carolina | 29201-2953 | United States |
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75235-6243 | United States |
| Metroplex Pulmonary and Sleep Center | Recruiting | McKinney | Texas | 75069-1898 | United States |
| Research Centers of America | Recruiting | McKinney | Texas | 75071 | United States |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D011658 | Pulmonary Fibrosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
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