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Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease (IMPROVE-Ischemia)

Primary Purpose

Ischemia, Coronary Artery Disease

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IMB-1018972
Placebo
Sponsored by
Imbria Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemia

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented history of stable angina (CCS grading I-III) or anginal equivalent for ≥1 month prior to screening
  • Ability to safely abstain from beta blockers for 48 hours prior to echo examinations in the opinion of the Investigator
  • Preserved LV systolic function, defined as LVEF≥50% by any imaging modality
  • Obstructive CAD and recent evidence of stress-induced myocardial ischemia

Exclusion Criteria:

  • Women of childbearing potential or who are currently pregnant or breast-feeding
  • Clinically indicated for coronary revascularization (PCI/CABG) at time of screening or clinically significant LMS or proximal LAD stenosis likely to warrant revascularization during the study period in the opinion of the investigator.
  • Type 1 insulin dependent diabetes mellitus (IDDM)
  • Presence of pacemaker, cardiac resynchronization therapy and/or implantable cardioverter defibrillator
  • Severe or clinically significant valvular heart disease
  • Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability

Sites / Locations

  • Imbria Investigational Site
  • Imbria Investigational Site
  • Imbria Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IMB-1018972 200mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs

Secondary Outcome Measures

Change in number of ischemic segments during hyperemia (ischemia defined as absolute MBF ≤2.0 ml/kg/min) as measured by adenosine stress 15O-H2O PET
Ischemia score defined on the basis of absolute hyperemic MBF as: (1) MBF 2.0-2.3 ml/g/min; (2) 1.7- 2.0 ml/g/min; (3) MBF <1.7 ml/g/min
Change in total ischemia burden measured as ischemia score summed across all segments as measured by adenosine stress 15O-H2O PET
Change in inducible perfusion defect expressed as % of myocardium as measured by adenosine stress 15O-H2O PET

Full Information

First Posted
March 18, 2021
Last Updated
August 14, 2023
Sponsor
Imbria Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04826172
Brief Title
Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease (IMPROVE-Ischemia)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 23, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imbria Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and tolerability of IMB-1018972 in subjects with obstructive CAD and inducible ischemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia, Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMB-1018972 200mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
IMB-1018972
Intervention Description
Modified release (MR) oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching oral tablet
Primary Outcome Measure Information:
Title
Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs
Time Frame
Randomization through Week 10 Safety Follow-up
Secondary Outcome Measure Information:
Title
Change in number of ischemic segments during hyperemia (ischemia defined as absolute MBF ≤2.0 ml/kg/min) as measured by adenosine stress 15O-H2O PET
Description
Ischemia score defined on the basis of absolute hyperemic MBF as: (1) MBF 2.0-2.3 ml/g/min; (2) 1.7- 2.0 ml/g/min; (3) MBF <1.7 ml/g/min
Time Frame
Baseline through Week 8
Title
Change in total ischemia burden measured as ischemia score summed across all segments as measured by adenosine stress 15O-H2O PET
Time Frame
Baseline through Week 8
Title
Change in inducible perfusion defect expressed as % of myocardium as measured by adenosine stress 15O-H2O PET
Time Frame
Baseline through Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented history of stable angina (CCS grading I-III) or anginal equivalent for ≥1 month prior to screening Ability to safely abstain from beta blockers for 48 hours prior to echo examinations in the opinion of the Investigator Preserved LV systolic function, defined as LVEF≥50% by any imaging modality Obstructive CAD and recent evidence of stress-induced myocardial ischemia Exclusion Criteria: Women of childbearing potential or who are currently pregnant or breast-feeding Clinically indicated for coronary revascularization (PCI/CABG) at time of screening or clinically significant LMS or proximal LAD stenosis likely to warrant revascularization during the study period in the opinion of the investigator. Type 1 insulin dependent diabetes mellitus (IDDM) Presence of pacemaker, cardiac resynchronization therapy and/or implantable cardioverter defibrillator Severe or clinically significant valvular heart disease Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor, MD
Organizational Affiliation
Imbria Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Imbria Investigational Site
City
Aarhus
Country
Denmark
Facility Name
Imbria Investigational Site
City
Turku
Country
Finland
Facility Name
Imbria Investigational Site
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease (IMPROVE-Ischemia)

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