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

Study Overview
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period, 2-Arm, 4-Sequence, Crossover Phase 1b Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ang-3070 in Subjects With Idiopathic Pulmonary Fibrosis Who Are Treatment-Naïve or Who Have Failed or Refused Standard of Care Treatment

Conditions
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Idiopathic Pulmonary Fibrosis (IPF)

Intervention / Treatment
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* Drug: ANG-3070
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Male or female subjects aged 40 years and older at the time of informed consent. 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. 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: Diagnosis of asthma or chronic obstructive pulmonary disease (COPD). Current tobacco use (quit at least 1 month prior to study for inclusion). Presence of active infection requiring ongoing therapy with systemic antibiotics and/or antivirals. Diagnosis of connective tissue disease. Known cause of ILD diagnosed. Active malignancy aside from local carcinoma. AST or ALT or total bilirubin > 2x upper limit of normal (ULN). Pregnancy and/or lactation; positive serum beta human chorionic gonadotropin (β-HCG) during screening.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Multicenter, randomized, double-blind, placebo-controlled, cross-over design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 500 mg QD<br>500 mg QD of ANG-3070 will be taken once a day for 10 days. | Drug: ANG-3070<br>* Orally administered tyrosine kinase inhibitor capsule.<br>|
| Experimental: 300 mg BID<br>300 mg BID of ANG-3070 will be taken twice a day for 10 days. | Drug: ANG-3070<br>* Orally administered tyrosine kinase inhibitor capsule.<br>|
| Placebo Comparator: Placebo-to-match 500 mg QD<br>Placebo-to-match 500 mg QD of ANG-3070 will be taken once a day for 10 days. | Drug: Placebo<br>* Orally administered placebo capsule<br>|
| Placebo Comparator: Placebo-to-match 300 mg BID<br>Placebo-to-match 300 mg BID of ANG-3070 will be taken twice a day for 10 days. | Drug: Placebo<br>* Orally administered placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from vital signs. |  | Period 1 Day 1 and Day 30 | 
| Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from 12-lead electrocardiograms (ECGs). |  | Period 1 Day 1 and Day 30 | 
| Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from laboratory test results. |  | Period 1 Day 1 and Day 30 | 
| Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from physical examination. |  | Period 1 Day 1 and Period 2 Day 1 |