Clinical Trials in the UK / NCT04053803
Active, not recruiting
Phase 2
An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia
NCT04053803 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Sickle Cell Disease
Investigational drug(s) / intervention(s)
IMR-687
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
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 | London | United Kingdom | |
| Guy's and St Thomas Hospital CRF | London | United Kingdom | |
| Royal London Hospital | London | United Kingdom |
Other trials for the same condition
A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
Active, not recruiting
A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)
Active, not recruiting
A Long-term Follow-up Study in Participants Who Received CTX001
Enrolling by invitation
Official registry record
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.
View NCT04053803 on ClinicalTrials.gov ↗ ← All trials in the UK