Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Insilico Medicine

Status and phase: Completed; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Treatments: Drug: Placebo; Drug: INS018_055

Study type: Interventional

Funder types: Industry

Identifiers

NCT05938920

INS018-055-003

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

5. 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 during the screening period, 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

Other protocol inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 4 patient groups, including a placebo group

INS018_055 30 mg QD

Experimental group

Description:

Group 1: INS018\_055 once daily up to 12 weeks, low dose

Treatment:

Drug: INS018_055

INS018_055 30 mg BID

Experimental group

Description:

Group 2: INS018\_055 twice daily up to 12 weeks, low dose

Treatment:

Drug: INS018_055

INS018_055 60 mg QD

Experimental group

Description:

Group 3: INS018\_055 once daily up to 12 weeks, high dose

Treatment:

Drug: INS018_055

Placebo

Placebo Comparator group

Description:

Group 4: Placebo once or twice daily up to 12 weeks

Treatment:

Drug: Placebo