Idiopathic Pulmonary Fibrosis (IPF)Phase 1NCT05387785
Study to Assess the Safety and Tolerability of ANG-3070 in Subjects With Idiopathic Pulmonary Fibrosis
A Phase 1 study testing ANG-3070 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Angion Biomedica Corp.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- ANG-3070
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Martin Robledo contact
About this study
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
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.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- ANG-3070, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANG-3070Drug
Orally administered tyrosine kinase inhibitor capsule.
PlaceboDrug
Orally administered placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| 500 mg QD | Experimental | 500 mg QD of ANG-3070 will be taken once a day for 10 days. Receives: Drug: ANG-3070 |
| 300 mg BID | Experimental | 300 mg BID of ANG-3070 will be taken twice a day for 10 days. Receives: Drug: ANG-3070 |
| Placebo-to-match 500 mg QD | Placebo comparator | Placebo-to-match 500 mg QD of ANG-3070 will be taken once a day for 10 days. Receives: Drug: Placebo |
| Placebo-to-match 300 mg BID | Placebo comparator | Placebo-to-match 300 mg BID of ANG-3070 will be taken twice a day for 10 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from vital signs.
Measured: Period 1 Day 1 and Day 30
Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from 12-lead electrocardiograms (ECGs).
Measured: Period 1 Day 1 and Day 30
Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from laboratory test results.
Measured: Period 1 Day 1 and Day 30
Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from physical examination.
Measured: Period 1 Day 1 and Period 2 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study startJun 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multicenter, randomized, double-blind, placebo-controlled, cross-over design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angion Biomedica Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387785
- Sponsor's protocol ID
- ANG3070-IPF-102
- Status last verified
- Jun 2022
- First submitted
- 17 May 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05387785
- Acronym / sponsor ID
- ANG3070-IPF-102
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Angion Biomedica CorpIndustry (pharma, biotech, devices)
- Study start
- Jun 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Multicenter, randomized, double-blind, placebo-controlled, cross-over design
| Arm | Type | Receives |
|---|---|---|
| 500 mg QD | Experimental | Drug: ANG-3070500 mg QD of ANG-3070 will be taken once a day for 10 days. |
| 300 mg BID | Experimental | Drug: ANG-3070300 mg BID of ANG-3070 will be taken twice a day for 10 days. |
| Placebo-to-match 500 mg QD | Placebo comparator | Drug: PlaceboPlacebo-to-match 500 mg QD of ANG-3070 will be taken once a day for 10 days. |
| Placebo-to-match 300 mg BID | Placebo comparator | Drug: PlaceboPlacebo-to-match 300 mg BID of ANG-3070 will be taken twice a day for 10 days. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANG-3070Orally administered tyrosine kinase inhibitor capsule. | Drug | 300 mg BID, 500 mg QD |
| PlaceboOrally administered placebo capsule | Drug | Placebo-to-match 300 mg BID, Placebo-to-match 500 mg QD |
Primary outcome
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Robledo contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ANG-3070 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Angion Biomedica Corp.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chantal Gosselin (857-378-4175, 3070IPF@angion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.