NCT04056195

Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP)

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Oscotec Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study in patients with persistent and chronic Immune Thrombocytopenia (ITP), who have failed to respond or relapsed after prior therapy, with a platelet count \<30,000/µL. Patient will be randomly assigned in 2 groups with two dose levels of SKI-O-703 200mg BID, 400 mg BID, and placebo; administered orally twice a day.

Detailed description

This study will evaluate the efficacy, safety, tolerability,pharmacokinetics (PK), and pharmacodynamics (PD) of select (200 mg BID and 400 mg BID) doses of SKI-O-703 in persistent and chronic ITP patients who have failed to respond or relapsed after prior therapy, with a platelet count \<30,000/µL. on 2 occasions at least 7 days apart with the confirmatory count on the first day of treatment. subjects will participate in 3 treatment groups (24 subjects in each of the active treatment groups and 12 subjects in the placebo group). The total study duration will be 20 weeks per subject, which consists of up to 4 weeks of screening period, 12 weeks of treatment period, and 4 weeks of follow-up period.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	SKI-O-703	The SKI-O-703 capsules will contain 100 mg of drug substance.
DRUG	Placebo oral tablet	Placebo capsules are filled with microcrystalline cellulose.

Timeline

• Start date: 2019-10-11
• Primary completion: 2023-01-10
• Completion: 2023-01-10
• First posted: 2019-08-14
• Last updated: 2024-07-10
• Results posted: 2024-07-10

Locations

27 sites across 5 countries: United States, Greece, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study