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

Phase 1

• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Interventions: Drug: Placebo; Drug: ANG-3070

• Registration Number: NCT05387785
• Lead Sponsor: Angion Biomedica Corp

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-24
• Status Verified: 2022-06
• Study Start: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-10
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo-to-match 500 mg QD	Placebo	Placebo-to-match 500 mg QD of ANG-3070 will be taken once a day for 10 days.
Placebo-to-match 300 mg BID	Placebo	Placebo-to-match 300 mg BID of ANG-3070 will be taken twice a day for 10 days.
500 mg QD	ANG-3070	500 mg QD of ANG-3070 will be taken once a day for 10 days.
300 mg BID	ANG-3070	300 mg BID of ANG-3070 will be taken twice a day for 10 days.

Primary Outcome Measures

Name	Time	Method
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