Status:
COMPLETED
Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP)
Lead Sponsor:
Oscotec Inc.
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ass...
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 pati...
Eligibility Criteria
Inclusion
- Diagnosis of primary ITP (persistent or chronic)
- Failed to respond or relapsed after at least 1 prior therapy, with a platelet count of \<30,000/µL on 2 occasions at least 7 days apart with the confirmatory count on the first day of treatment
- Adequate hematologic, hepatic, and renal function
- ECOG performance status of 0, 1, or 2
- Male and female subjects, the subject and their partners of childbearing potential agree to use medically acceptable methods of contraception during the study and for 6 months following discontinuation of study drug (excluding women who are not of childbearing potential and men who have been sterilized. Men who have been sterilized should be confirmed to have negative sperm count on 2 consecutive occasions.)
- Male subjects agree not to donate sperm for 90 days after the last dose of study drug
- Female subjects have negative pregnancy tests at Screening.
Exclusion
- History of current, active malignancy requiring or likely to require chemotherapeutic or surgical treatment during the study, with the exception of non-melanoma skin cancer, carcinoma in situ of the cervix, and localized prostate cancer managed by active surveillance
- Transfusion with blood or blood products or plasmapheresis within 2 weeks before the first administration of study drug
- History of known inherited coagulopathy, or recent arterial or deep venous thrombosis within the preceding 6 months
- Change in corticosteroid or immunosuppressant dose within 2 weeks prior to Day 1
- Treatment with thrombopoietin receptor agonists within 2 weeks before Day 1
- Treatment with rituximab or splenectomy within the 8 weeks prior to Day 1
- Treatment with intravenous immunoglobulins (IVIGs) within 4 weeks prior to Day 1
- Acute infection requiring oral antibiotics within 2 weeks
- Infections requiring intravenous antibiotics or hospitalization within 3 months
- Positive test results at Screening for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibody or positive result for hepatitis B core antibody with a negative result for hepatitis B surface antigen
- Received live vaccine within 28 days prior to Day 1 or plan to receive one during the study
- History or presence of any gastrointestinal, hepatic, or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
- Uncontrolled hypertension
- Subject had 12-lead electrocardiogram (ECG) findings of corrected QT interval by Fridericia formula (QTcF) \> 450 msec (males) or \> 470 msec (females), cardiac arrhythmias, or clinically significant cardiac or ECG abnormalities
- Subject received any investigational medication within 30 days or 5 half-lives - Concomitant use of any anticoagulants and platelet aggregation inhibiting drugs including aspirin (within 14 days of planned dosing through end of follow-up)
- Female subject who is currently pregnant or breastfeeding
- Prior treatment with a SYK inhibitor
- Planned surgery in the time frame of the dosing period.
Key Trial Info
Start Date :
October 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04056195
Start Date
October 11 2019
End Date
January 10 2023
Last Update
July 10 2024
Active Locations (27)
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1
University of Southern California, 1441 Eastlake Ave.
Los Angeles, California, United States, 90033
2
Duke University Medical Center, 2301 Erwin Road
Durham, North Carolina, United States, 22705
3
East Carolina University, 600 Moye Boulevard
Greenville, North Carolina, United States, 27834
4
The Cleveland Clinic Foundation, 9500 Euclid Avenue
Cleveland, Ohio, United States, 44195