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

Idiopathic Pulmonary Fibrosis (IPF) Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05387785
• Other study ID #: ANG3070-IPF-102
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2022
• Est. completion date: November 2022

Study information

• Verified date: June 2022
• Source: Angion Biomedica Corp
• Contact: Chantal Gosselin
• Phone: 857-378-4175
• Email: 3070IPF[@]angion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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 (ß-HCG) during screening.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Idiopathic Pulmonary Fibrosis (IPF)
• Pulmonary Fibrosis

Intervention

Drug:
• ANG-3070
Orally administered tyrosine kinase inhibitor capsule.
• Placebo
Orally administered placebo capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Angion Biomedica Corp

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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