Menu
Recruiting NCT05975983

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Phase II Interventional Idiopathic Pulmonary Fibrosis (IPF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: INS018_055, Placebo.
Who it may be relevant to
Registry conditions: Idiopathic Pulmonary Fibrosis (IPF). Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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).

Detailed description

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).

Interventions

  • Drug INS018_055
    Pharmaceutical formulation: Tablet Mode of Administration: Oral
  • Drug Placebo
    Pharmaceutical formulation: Tablet Mode of Administration: Oral

Primary outcome measures

  • Percentage of subjects 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 (12)
  • Maximum plasma concentration (Cmax) of INS018_055 and its major 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 8, End of Treatment (EOT))]
  • Time to reach maximum plasma concentration (Tmax) of INS018_055 and its major 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 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: Week 0/Visit 2 up to Week 12]

Eligibility 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
  • Meeting all of the following criteria during the screening period:
  • FVC ≥40% predicted normal
  • DLCO corrected for Hgb ≥25% and <80% predicted 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 12 centers
  • University of Alabama at Birmingham — Birmingham
  • HonorHealth Research Institute — Scottsdale
  • Keck School of Medicine of USC — Los Angeles
  • Florida Lung Asthma and Sleep Specialist — Celebration
  • Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando — Orlando
  • Southeastern Research Center — Winston-Salem
  • University of Oklahoma Health Sciences Center (OUHSC) — Oklahoma City
  • Temple University Hospital-Temple Lung Center — Philadelphia
  • … and 4 more centers

Identifiers

NCT: NCT05975983 · INS018-055-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗