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An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia

Primary Purpose

Sickle Cell Disease

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IMR-687
Sponsored by
Imara, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Completed Study IMR-SCD-102.
  2. Female subjects must not be pregnant, not be breast feeding, and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner.
  3. Subjects must be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained to them
  4. Subjects must be willing and able to complete all study assessments and procedures and to communicate effectively with the investigator and site staff.

Exclusion Criteria:

  1. Subjects with Hb >12.5 g/dL or <6 g/dL
  2. Subjects with known active hepatitis B or hepatitis C, with active or acute event of malaria or who are known to be positive for human immunodeficiency virus (HIV)
  3. eGFR <50 mL/min
  4. AST/ALT > 3x the upper limit of normal

Sites / Locations

  • University of Connecticut Health Center
  • Foundation for Sickle Cell Disease Research
  • Baylor Scott & White Medical Center - Temple
  • Bristol Haematology and Oncology Centre
  • University College London Hospital NHS Foundation Trust
  • Guy's and St Thomas Hospital CRF
  • Royal London Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients with adverse events and serious adverse events
Incidence of Adverse Events Incidence of Serious Adverse Events
Proportion of patients with changes in safety cardiac parameters
a. Changes in 12-lead ECG parameters that are clinically significant and measured in milliseconds (ms). The parameters are: PR interval, QRS duration, QT interval, ST segment duration and T wave duration.
Proportion of patients with changes in clinical laboratory tests
a. Clinically significant changes in clinical laboratory tests including serum chemistry, serum hematology and urinalysis
Proportion of patients with clinically significant abnormal vital signs
Blood pressure measured in mmHg Pulse measured in beats per minute Respiration rate measured in breaths per minutes Temperature as measured in degrees F0 or C0

Secondary Outcome Measures

Full Information

First Posted
July 18, 2019
Last Updated
March 2, 2022
Sponsor
Imara, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04053803
Brief Title
An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia
Official Title
An Open-label Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia) Who Participated in Study IMR-SCD-102
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 22, 2019 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
This is an open-label extension study of IMR-687 in adult patients who completed Imara's blinded Phase 2a study (IMR-SCD-102). The open-label extension study will evaluate long-term safety and tolerability.
Detailed Description
This is an open-label extension study of IMR-687 in adult patients with SCA who were previously participants in the Phase 2a study titled "A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients with Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)." This open-label extension study with IMR-687 will evaluate the long-term safety and tolerability of IMR 687 in adult SCA patients. Exploratory long-term PD parameters will also be examined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Label
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IMR-687
Intervention Description
Oral administration of once daily IMR-687
Primary Outcome Measure Information:
Title
Proportion of patients with adverse events and serious adverse events
Description
Incidence of Adverse Events Incidence of Serious Adverse Events
Time Frame
Baseline to Month 49
Title
Proportion of patients with changes in safety cardiac parameters
Description
a. Changes in 12-lead ECG parameters that are clinically significant and measured in milliseconds (ms). The parameters are: PR interval, QRS duration, QT interval, ST segment duration and T wave duration.
Time Frame
Baseline to Month 49
Title
Proportion of patients with changes in clinical laboratory tests
Description
a. Clinically significant changes in clinical laboratory tests including serum chemistry, serum hematology and urinalysis
Time Frame
Baseline to Month 49
Title
Proportion of patients with clinically significant abnormal vital signs
Description
Blood pressure measured in mmHg Pulse measured in beats per minute Respiration rate measured in breaths per minutes Temperature as measured in degrees F0 or C0
Time Frame
Baseline to Month 49

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed Study IMR-SCD-102. Female subjects must not be pregnant, not be breast feeding, and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner. Subjects must be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained to them Subjects must be willing and able to complete all study assessments and procedures and to communicate effectively with the investigator and site staff. Exclusion Criteria: Subjects with Hb >12.5 g/dL or <6 g/dL Subjects with known active hepatitis B or hepatitis C, with active or acute event of malaria or who are known to be positive for human immunodeficiency virus (HIV) eGFR <50 mL/min AST/ALT > 3x the upper limit of normal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Tang, MD
Organizational Affiliation
Imara, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Foundation for Sickle Cell Disease Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Baylor Scott & White Medical Center - Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
Country
United Kingdom
Facility Name
University College London Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Guy's and St Thomas Hospital CRF
City
London
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia

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