At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 61 enrolled
Drug / intervention
SKI-O-703 +1 moredrug
Likely dose
SKI-O-703 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating SKI-O-703 and Placebo oral tablet for Immune Thrombocytopenia. Completed, enrolled 61 participants across 27 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmune Thrombocytopenia
CountriesGreece, Poland, South Korea, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartOct 2019
Primary CompletionJan 2023
TodayJul 2026
First PostedAug 14, 2019
Enrollment StartOct 11, 2019
Primary CompletionJan 10, 2023
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.9 years ago
Interventions
SKI-O-703drug
The SKI-O-703 capsules will contain 100 mg of drug substance.
Placebo oral tabletdrug
Placebo capsules are filled with microcrystalline cellulose.