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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05387785
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Angion Biomedica Corp
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis (IPF)

Arms & Interventions

Arms

Experimental: 500 mg QD

500 mg QD of ANG-3070 will be taken once a day for 10 days.

Experimental: 300 mg BID

300 mg BID of ANG-3070 will be taken twice a day for 10 days.

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.

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.

Interventions

Drug: - ANG-3070

Orally administered tyrosine kinase inhibitor capsule.

Drug: - Placebo

Orally administered placebo capsule

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Chantal Gosselin

3070IPF@angion.com

857-378-4175

For additional contact information, you can also visit the trial on clinicaltrials.gov.