Study to Assess the Safety and Tolerability of ANG-3070 in Subjects With Idiopathic Pulmonary Fibrosis
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
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2022
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2022
CompletedFirst Posted
Study publicly available on registry
May 24, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedJune 10, 2022
June 1, 2022
5 months
May 17, 2022
June 8, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from vital signs.
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).
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.
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.
Period 1 Day 1 and Period 2 Day 1
Study Arms (4)
500 mg QD
EXPERIMENTAL500 mg QD of ANG-3070 will be taken once a day for 10 days.
300 mg BID
EXPERIMENTAL300 mg BID of ANG-3070 will be taken twice a day for 10 days.
Placebo-to-match 500 mg QD
PLACEBO COMPARATORPlacebo-to-match 500 mg QD of ANG-3070 will be taken once a day for 10 days.
Placebo-to-match 300 mg BID
PLACEBO COMPARATORPlacebo-to-match 300 mg BID of ANG-3070 will be taken twice a day for 10 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- Diagnosis of asthma or chronic obstructive pulmonary disease (COPD).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2022
First Posted
May 24, 2022
Study Start
June 1, 2022
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
June 10, 2022
Record last verified: 2022-06