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NCT Number: NCT04053803

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

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bristol Haematology and Oncology Centre, Bristol, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMR-687

Drug

Oral administration of once daily IMR-687

Primary outcomes

  1. Proportion of patients with adverse events and serious adverse events

    Time frame: Baseline to Month 49

    • Incidence of Adverse Events
    • 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

    • 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

Sponsors and collaborators

Lead sponsor

Imara, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2019
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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