An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Open Label
|
Drug: IMR-687
Oral administration of once daily IMR-687
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with adverse events and serious adverse events [Baseline to Month 49]
Incidence of Adverse Events 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]
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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Connecticut Health Center | Farmington | Connecticut | United States | 06030 |
| 2 | Foundation for Sickle Cell Disease Research | Hollywood | Florida | United States | 33021 |
| 3 | Baylor Scott & White Medical Center - Temple | Temple | Texas | United States | 76508 |
| 4 | Bristol Haematology and Oncology Centre | Bristol | United Kingdom | ||
| 5 | University College London Hospital NHS Foundation Trust | London | United Kingdom | NW1 2PG | |
| 6 | Guy's and St Thomas Hospital CRF | London | United Kingdom | ||
| 7 | Royal London Hospital | London | United Kingdom |
Sponsors and Collaborators
- Imara, Inc.
Investigators
- Study Director: Karen Tang, MD, Imara, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IMR-SCD-102-EXT
- 2018-003805-25