NL-OMON55249
Completed
Phase 2
A Phase 2b Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell Disease - IMR-SCD-301
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- IMARA, Inc.,
- Enrollment
- 18
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Each subject must meet all the following criteria to be enrolled in the study:
- •1\. Male or female aged \*18 to \*65 years at the time of informed consent form
- •(ICF) signing.
- •2\. Confirmed diagnosis of SCD (HbSS, HbS\*0 thalassemia, or HbS\*\+ 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 2 and no more than 12 documented episodes of
- •VOC in the past 12 months at the time of ICF signing and at randomization (Day
- •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
Exclusion Criteria
- •Subjects who meet any of the following criteria will be excluded from the study:
- •1\. Hospital discharge for sickle cell crisis or other vaso occlusive event
- •within the 4 days prior to randomization (Day 1\).
- •2\. Subjects participating in a chronic/prophylactic RBC transfusion program
- •(i.e., regularly scheduled RBC transfusions); any transfusions within 21 days
- •of screening or baseline Hb measurements.
- •3\. Subjects with 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).
Outcomes
Primary Outcomes
Not specified
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