search
Back to results

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

Primary Purpose

Idiopathic Pulmonary Fibrosis (IPF)

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ANG-3070
Placebo
Sponsored by
Angion Biomedica Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Placebo Comparator

    Arm Label

    500 mg QD

    300 mg BID

    Placebo-to-match 500 mg QD

    Placebo-to-match 300 mg BID

    Arm Description

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

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

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

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

    Outcomes

    Primary Outcome Measures

    Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from vital signs.
    Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from 12-lead electrocardiograms (ECGs).
    Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from laboratory test results.
    Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from physical examination.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 17, 2022
    Last Updated
    June 8, 2022
    Sponsor
    Angion Biomedica Corp
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05387785
    Brief Title
    Study to Assess the Safety and Tolerability of ANG-3070 in Subjects With Idiopathic Pulmonary Fibrosis
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    November 2022 (Anticipated)
    Study Completion Date
    November 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Angion Biomedica Corp

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Idiopathic Pulmonary Fibrosis (IPF)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Model Description
    Multicenter, randomized, double-blind, placebo-controlled, cross-over design
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    500 mg QD
    Arm Type
    Experimental
    Arm Description
    500 mg QD of ANG-3070 will be taken once a day for 10 days.
    Arm Title
    300 mg BID
    Arm Type
    Experimental
    Arm Description
    300 mg BID of ANG-3070 will be taken twice a day for 10 days.
    Arm Title
    Placebo-to-match 500 mg QD
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo-to-match 500 mg QD of ANG-3070 will be taken once a day for 10 days.
    Arm Title
    Placebo-to-match 300 mg BID
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo-to-match 300 mg BID of ANG-3070 will be taken twice a day for 10 days.
    Intervention Type
    Drug
    Intervention Name(s)
    ANG-3070
    Intervention Description
    Orally administered tyrosine kinase inhibitor capsule.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Orally administered placebo capsule
    Primary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Male or female subjects aged 40 years and older at the time of informed consent. 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. 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: Diagnosis of asthma or chronic obstructive pulmonary disease (COPD). Current tobacco use (quit at least 1 month prior to study for inclusion). Presence of active infection requiring ongoing therapy with systemic antibiotics and/or antivirals. Diagnosis of connective tissue disease. Known cause of ILD diagnosed. Active malignancy aside from local carcinoma. AST or ALT or total bilirubin > 2x upper limit of normal (ULN). Pregnancy and/or lactation; positive serum beta human chorionic gonadotropin (β-HCG) during screening.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chantal Gosselin
    Phone
    857-378-4175
    Email
    3070IPF@angion.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Martin Robledo
    Email
    3070IPF@angion.com

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs