PACTR202012920757784招募中2 期
A Phase 2b Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- IMARA Inc
- 入组人数
- 99
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •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
- •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 professional-instructed 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 × 109
- •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.
- •7. Female subjects must not be pregnant or breastfeeding and be highly unlikely to become
- •pregnant. Male subjects must be unlikely to impregnate a partner. Male or female subjects
- •must meet at least one of the following criteria:
- •A female subject who is not of reproductive potential is eligible without requiring the use
- •of contraception. A female subject who is not of reproductive potential is defined as one
- •who: (1) has reached
排除标准
- •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 × 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:
- •a. Basal or squamous cell carcinoma of the skin
- •b. Carcinoma in situ of the cervix
- •c. Carcinoma in situ of the breast
- •d. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes,
- •metastasis clinical staging system)
- •A history of a clinically significant allergic reaction or hypersensitivity, as judged by the
- •investigator, to any drug or any component of the study drug formulations used in the study
- •(see Investigator’s Brochure).
- •11. History of unstable or deteriorating cardiac or pulmonary disease within 6 months before
- •signing the ICF, including but not limited to the following:
- •a. Unstable angina pectoris or myocardial infarction or elective coronary intervention
- •b. Congestive heart failure requiring hospitalization
- •c. Uncontrolled clinically significant arrhythmias
- •12. Any condition affecting drug absorption, such as major surgery involving the stomach or small
- •intestine (prior cholecystectomy is acceptable).
- •13. On ECG testing at ICF signing and/or randomization (Day 1), a corrected QT interval,
- •Fridericia’s formula (QTcF) >450 ms in men and >470 ms in women or the presence of
- •clinically significant ECG abnormalities as determined by the investigator.
- •14. A history of major surgery within 4 weeks or minor surgery within 2 weeks of randomization
- •15. Stroke requiring medical intervention within 24 weeks prior to randomization (Day 1).
- •16. Subjects taking direct acting oral anti-coagulants (DOACs) apixaban, dabigatran, rivaroxaban,
- •edoxaban, or ticagrelor, or taking warfarin, are excluded due to the possibility of a cytochrome
- •P450 (CYP)3A-mediated drug interaction, unless they stopped the treatment at least 28 days
- •prior to randomization (Day 1); other oral anti-c
研究者
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