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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 500 mg QD | Experimental | 500 mg QD of ANG-3070 will be taken once a day for 10 days. |
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| 300 mg BID | Experimental | 300 mg BID of ANG-3070 will be taken twice a day for 10 days. |
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| Placebo-to-match 500 mg QD | Placebo Comparator | Placebo-to-match 500 mg QD of ANG-3070 will be taken once a day for 10 days. |
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| Placebo-to-match 300 mg BID | Placebo Comparator | Placebo-to-match 300 mg BID of ANG-3070 will be taken twice a day for 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANG-3070 | Drug | Orally administered tyrosine kinase inhibitor capsule. |
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| 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 |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chantal Gosselin | Contact | 857-378-4175 | 3070IPF@angion.com | |
| Martin Robledo | Contact | 3070IPF@angion.com |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Multicenter, randomized, double-blind, placebo-controlled, cross-over design
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| Placebo | Drug | Orally administered placebo capsule |
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