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

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ClinicalTrials.gov Identifier: NCT04053803
Recruitment Status : Enrolling by invitation
First Posted : August 13, 2019
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Imara, Inc.

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: IMR-687 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 22, 2019
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: Open Label Drug: IMR-687
Oral administration of once daily IMR-687




Primary Outcome Measures :
  1. Proportion of patients with adverse events and serious adverse events [ Time Frame: Baseline to Month 49 ]
    1. Incidence of Adverse Events
    2. Incidence of Serious Adverse Events

  2. Proportion of patients with changes in safety cardiac parameters [ Time Frame: Baseline to Month 49 ]

    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.


  3. Proportion of patients with changes in clinical laboratory tests [ Time Frame: Baseline to Month 49 ]
    a. Clinically significant changes in clinical laboratory tests including serum chemistry, serum hematology and urinalysis

  4. Proportion of patients with clinically significant abnormal vital signs [ Time Frame: Baseline to Month 49 ]
    1. Blood pressure measured in mmHg
    2. Pulse measured in beats per minute
    3. Respiration rate measured in breaths per minutes
    4. Temperature as measured in degrees F0 or C0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053803


Locations
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United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Florida
Foundation for Sickle Cell Disease Research
Hollywood, Florida, United States, 33021
United States, Texas
Baylor Scott & White Medical Center - Temple
Temple, Texas, United States, 76508
United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
University College London Hospital NHS Foundation Trust
London, United Kingdom, NW1 2PG
Guy's and St Thomas Hospital CRF
London, United Kingdom
Royal London Hospital
London, United Kingdom
Sponsors and Collaborators
Imara, Inc.
Investigators
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Study Director: Eleanor Lisbon, MD, MPH Imara, Inc.
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Responsible Party: Imara, Inc.
ClinicalTrials.gov Identifier: NCT04053803    
Other Study ID Numbers: IMR-SCD-102-EXT
2018-003805-25 ( EudraCT Number )
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn