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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Intervention / Treatment: Drug: Placebo; Drug: ANG-3070

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chantal Gosselin; Phone Number: 857-378-4175; Email: 3070IPF@angion.com
• Study Contact Backup: Name: Martin Robledo; Email: 3070IPF@angion.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Angion Biomedica Corp

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: ANG3070-IPF-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No