EUCTR2019-004471-39-IT
Active, not recruiting
Phase 1
A Phase 2b Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell Disease - NA
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Sickle Cell Disease
- Sponsor
- IMARA Inc.
- Enrollment
- 99
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male or female aged \=18 to \=65 years at the time of informed consent form (ICF) signing.
- •2\.Confirmed diagnosis of SCD (HbSS, HbSB0 thalassemia, or HbSB\+thalassemia) in the medical record; if not available, the diagnosis must be confirmed at the site's local laboratory instead.
- •3\.Subjects must have had at least 1 and no more than 12 documented episodes of VOC in the past 12 months at the time of ICF signing and at
- •randomization (Day 1\). For study eligibility, VOC is defined as a documented episode of an acute painful crisis (for which there was not an explanation other than VOC) that involved moderate to severe pain lasting for at least 2 hours and at least one of the following:
- •Use of escalated analgesia (including healthcare professionalinstructed use of an analgesic prescription)
- •A hospital, emergency department, or clinic visit and/or healthcare telephone consultation at the time of occurrence
- •Diagnosis of acute chest syndrome (ACS) (defined as an acute illness characterized by fever and/or respiratory symptoms, accompanied by a new pulmonary infiltrate on a chest X ray), hepatic sequestration, or splenic sequestration
- •4\.Hemoglobin (Hb) of \>5\.5 and \<10\.5 g/dL.
- •5\.Absolute reticulocyte count \=80 × 10^9/L.
- •6\.Subjects receiving HU must have received it continuously for at least 6 months prior to signing the ICF, and must have been on a stable dose for at least 3 months prior to signing the ICF, with no anticipated need for dose adjustments during the study including the screening period, in the opinion of the investigator.
Exclusion Criteria
- •1\.Hospital discharge for sickle cell crisis or other vaso occlusive event within the 4 days prior to randomization (Day 1\).
- •2\.Red blood cell transfusion within 60 days of signing the ICF or on chronic transfusion therapy regimen. Transfusion status must be reassessed at randomization (Day 1\). Note: If a subject requires a transfusion during the screening period, they may be rescreened up to one time.
- •3\.Subjects with hereditary persistence of HbF (i.e., HbF \>25% at screening).
- •4\.Subjects with known active hepatitis A, hepatitis B, or hepatitis C, with active or acute event of malaria, or who are known to be positive for human immunodeficiency virus (HIV).
- •5\.For female subjects of childbearing potential, a positive serum human chorionic gonadotropin (hCG) test (screening) or a positive urine hCG test at randomization (Day 1\).
- •6\.Estimated glomerular filtration rate (eGFR) \<45 mL/min as calculated by the equation from the Modification of Diet in Renal Disease Study using creatinine, age, sex, and ethnicity.
- •7\.Alanine aminotransferase or aspartate aminotransferase \>3 x the upper limit of normal.
- •8\.Body mass index (BMI) \<17\.0 kg/m2 and a total body weight \<45 kg; or a BMI \>35 kg/m2\.
- •9\.Current or history of malignancies (solid tumors and hematological malignancies), unless the subject has been free of the disease (including completion of any active or adjuvant treatment for prior malignancy) for \=5 years. However, subjects with the following history/concurrent conditions are allowed if, in the opinion of the investigator, the condition has been adequately diagnosed and is determined to be clinically in remission, and the subject's participation in the study would not
- •represent a safety concern:
Outcomes
Primary Outcomes
Not specified
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