A Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease
A Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease
The purpose of this study was to evaluate the safety and tolerability, and the
 pharmacokinetic and biologic activity of INCB059872 in participants with sickle cell disease.
Inclusion Criteria:

 -  Diagnosis of SCD (sickle cell SS) confirmed through hemoglobin electrophoresis.

 -  Must be red blood cell (RBC) transfusion-independent (not currently on regularly
 scheduled transfusions) for ≥ 3 months from the time of first dose of study drug.

 -  No RBC transfusion within 30 days of first dose of study drug.

 -  Hydroxyurea (HU) refractory

 -Must not have received HU therapy during the 3 months before receiving study drug.

 -  Creatinine clearance ≥ 60 mL/min based on the institutional formula.

 -  Willingness to avoid pregnancy or fathering children.

 Exclusion Criteria:

 -  Any unresolved toxicity ≥ Grade 2 from previous therapy except for stable chronic
 toxicities not expected to resolve.

 -  Pregnant or nursing women or participants expecting to conceive or father children
 within the projected duration of the study, starting with screening visit through
 completion of safety follow-up.

 -  Received an investigational study drug within 28 days or 5 half-lives (whichever is
 longer) before receiving the first dose of study drug (requirement may be waived with
 medical monitor approval).

 -  Chronic or current active infectious disease requiring systemic antibiotics,
 antifungal, or antiviral treatment.

 -  Prior receipt of LSD1 inhibitor therapy for any indication.