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

Angion

Status and phase: Not yet enrolling; Phase 1

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Treatments: Drug: ANG-3070; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05387785

ANG3070-IPF-102

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 4 patient groups, including a placebo group

500 mg QD

Experimental group

Description:

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

Treatment:

Drug: ANG-3070

300 mg BID

Experimental group

Description:

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

Treatment:

Drug: ANG-3070

Placebo-to-match 500 mg QD

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Placebo-to-match 300 mg BID

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo