Study to Assess the Safety and Tolerability of ANG-3070 in Subjects With Idiopathic Pulmonary Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2022-11-30

Brief Summary

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The purpose of this study is to assess safety and tolerability of once daily (QD) and twice daily (BID) dosing of ANG-3070 in subjects with idiopathic pulmonary fibrosis (IPF) who are treatment-naïve, refused therapy, or discontinued for any reason current standard of care with nintedanib or pirfenidone.

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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis (IPF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Multicenter, randomized, double-blind, placebo-controlled, cross-over design

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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500 mg QD

500 mg QD of ANG-3070 will be taken once a day for 10 days.

Group Type EXPERIMENTAL

ANG-3070

Intervention Type DRUG

Orally administered tyrosine kinase inhibitor capsule.

300 mg BID

300 mg BID of ANG-3070 will be taken twice a day for 10 days.

Group Type EXPERIMENTAL

ANG-3070

Intervention Type DRUG

Orally administered tyrosine kinase inhibitor capsule.

Placebo-to-match 500 mg QD

Placebo-to-match 500 mg QD of ANG-3070 will be taken once a day for 10 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Orally administered placebo capsule

Placebo-to-match 300 mg BID

Placebo-to-match 300 mg BID of ANG-3070 will be taken twice a day for 10 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Orally administered placebo capsule

Interventions

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ANG-3070

Orally administered tyrosine kinase inhibitor capsule.

Intervention Type DRUG

Placebo

Orally administered placebo capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subject must be willing and of sufficient mental capacity to give written informed consent and comprehend the importance of adhering to study treatment and requirements.
2. Male or female subjects aged 40 years and older at the time of informed consent.
3. Substantiated diagnosis of IPF based on clinical, radiological, and/or pathologic data to the exclusion of alternate diagnoses that would contribute to extant interstitial lung disease (ILD) based on the opinion of the subject's physician using current diagnostic criteria.
4. Subject:

* Is naïve to therapy with nintedanib or pirfenidone OR
* Refuses therapy with nintedanib or pirfenidone OR
* Had nintedanib or pirfenidone discontinued due to any reason, 4-week washout required

Exclusion Criteria

1. Diagnosis of asthma or chronic obstructive pulmonary disease (COPD).
2. Current tobacco use (quit at least 1 month prior to study for inclusion).
3. Presence of active infection requiring ongoing therapy with systemic antibiotics and/or antivirals.
4. Diagnosis of connective tissue disease.
5. Known cause of ILD diagnosed.
6. Active malignancy aside from local carcinoma.
7. AST or ALT or total bilirubin \> 2x upper limit of normal (ULN).
8. Pregnancy and/or lactation; positive serum beta human chorionic gonadotropin (β-HCG) during screening.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No