ClinicalTrials.gg
Status unknownNCT05387785Updated Jun 10, 2022

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

A Phase 1 interventional study of ANG-3070 and Placebo in Idiopathic Pulmonary Fibrosis (IPF), sponsored by Angion Biomedica Corp. Status unknown. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2022-06-10.

Sponsored by Angion Biomedica Corp · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis (IPF)
03

In context

Idiopathic Pulmonary Fibrosis

576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.

This study's planned enrollment of 20 is below the median of 55 across 389 interventional studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

Angion Biomedica Corp is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject must be willing and of sufficient mental capacity to give written 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

Exclusion Criteria:

  1. Diagnosis of asthma or (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 aside from local carcinoma.
  7. or ALT or total > 2x (ULN).
  8. Pregnancy and/or lactation; positive serum beta human chorionic gonadotropin (β-HCG) during screening.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    500 mg QD

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

    Drug: ANG-3070

  • Experimental
    300 mg BID

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

    Drug: ANG-3070

  • 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

  • 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

Interventions

  • Orally administered tyrosine kinase inhibitor capsule.

  • DrugPlacebo

    Orally administered placebo capsule

06

What researchers measure

Primary outcomes

  1. Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from vital signs.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: Period 1 Day 1 and Period 2 Day 1

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05387785
Lead sponsor
Angion Biomedica Corp
Responsible party
Sponsor
First posted
May 24, 2022
Start date
Jun 2022 (estimated)
Primary completion
Nov 2022 (estimated)
Completion
Nov 2022 (estimated)
Last update
Jun 10, 2022

Study contacts

Chantal Gosselin
Contact
3070IPF@angion.com
857-378-4175
Martin Robledo
Contact
3070IPF@angion.com

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: ANG3070

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