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