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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003805-25 | EudraCT Number |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMR-687 | Drug | Oral administration of once daily IMR-687 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with adverse events and serious adverse events |
| Baseline to Month 49 |
| Proportion of patients with changes in safety cardiac parameters | 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. | Baseline to Month 49 |
| Proportion of patients with changes in clinical laboratory tests | a. Clinically significant changes in clinical laboratory tests including serum chemistry, serum hematology and urinalysis | Baseline to Month 49 |
| Proportion of patients with clinically significant abnormal vital signs |
| Baseline to Month 49 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Tang, MD | Imara, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States | ||
| Foundation for Sickle Cell Disease Research |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 24, 2022 | Jun 17, 2022 | 3 | ||
| Jun 29, 2022 |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| Hollywood |
| Florida |
| 33021 |
| United States |
| Baylor Scott & White Medical Center - Temple | Temple | Texas | 76508 | United States |
| Bristol Haematology and Oncology Centre | Bristol | United Kingdom |
| University College London Hospital NHS Foundation Trust | London | NW1 2PG | United Kingdom |
| Guy's and St Thomas Hospital CRF | London | United Kingdom |
| Royal London Hospital | London | United Kingdom |
| Jul 19, 2022 |
| 4 |
| Apr 29, 2025 | May 13, 2025 | 5 |
| Apr 16, 2026 | May 6, 2026 | 6 |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |