IMR-687: Oral administration of once daily IMR-687
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Proportion of patients with adverse events and serious adverse events — Baseline to Month 49 1. Incidence of Adverse Events
2. Incidence of Serious Adverse Events
Proportion of patients with changes in safety cardiac parameters — 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.
Proportion of patients with changes in clinical laboratory tests — Baseline to Month 49 a. Clinically significant changes in clinical laboratory tests including serum chemistry, serum hematology and urinalysis
Proportion of patients with clinically significant abnormal vital signs — 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
Trial sites (7)
Facility
City
Region
Status
University of Connecticut Health Center
Farmington
Connecticut
Foundation for Sickle Cell Disease Research
Hollywood
Florida
Baylor Scott & White Medical Center - Temple
Temple
Texas
Bristol Haematology and Oncology Centre
Bristol
United Kingdom
University College London Hospital NHS Foundation Trust
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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