A Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell Disease
A phase 2b, randomized, double-blind, placebo-controlled, multicenter study of subjects with sickle cell disease (SCD; homozygous sickle hemoglobin \[HbSS\], sickle-β0 \[HbSβ0\] thalassemia, or sickle-β+ \[HbSβ+\] thalassemia) to evaluate the safety and efficacy of the phosphodiesterase type 9 (PDE9) inhibitor, IMR-687, administered once daily (qd) for 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
115
Effect on the Incidence of Vaso-occlusive Crises (VOCs)
Annualized rate of VOCs. For each subject, the total number of VOCs on treatment were divided by the time on treatment divided by 52 weeks. The median was then summarized.
Time frame: Baseline to Week 52
Proportion of Patients With Adverse Events and Serious Adverse Events
Incidence of Adverse Events Incidence of Serious Adverse Events
Time frame: Baseline to Week 56
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