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

• Sponsor: Angion Biomedica Corp (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05387785
• Collaborator: (none)
• Enrollment: 20
• Arms: 4
• Anticipated Duration (Months): 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis (IPF)	Drug: ANG-3070; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Multicenter, randomized, double-blind, placebo-controlled, cross-over designMulticenter, randomized, double-blind, placebo-controlled, cross-over design
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Angion Biomedica Corp

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Angion Biomedica Corp
• ClinicalTrials.gov Identifier: NCT05387785
• Other Study ID Numbers: ANG3070-IPF-102
• First Posted: May 24, 2022
• Last Update Posted: Jun 10, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis

Study Results

No Results Posted as of Jun 10, 2022