A Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease

• Status: Terminated
• Trial end date: 2018-10-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

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.