Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP)
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| ClinicalTrials.gov Identifier: NCT04056195 |
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Recruitment Status : Unknown
Verified September 2020 by Oscotec Inc..
Recruitment status was: Recruiting
First Posted : August 14, 2019
Last Update Posted : September 18, 2020
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Sponsor:
Oscotec Inc.
Information provided by (Responsible Party):
Oscotec Inc.
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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 assigned in 2 groups with two dose levels of SKI-O-703 200mg BID, 400 mg BID, and placebo; administered orally twice a day.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Immune Thrombocytopenia | Drug: SKI-O-703 Drug: Placebo oral tablet | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Actual Study Start Date : | October 11, 2019 |
| Estimated Primary Completion Date : | February 2021 |
| Estimated Study Completion Date : | February 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: SKI-O-703 200 mg
2 capsules of 100 mg SKI-O-703 BID (twice a day) 12 hours apart + 2 capsules of placebo during 12 weeks
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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. |
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Experimental: SKI-O-703 400 mg
4 capsules of 100 mg SKI-O-703 + 0 capsules of placebo during 12 weeks
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Drug: SKI-O-703
The SKI-O-703 capsules will contain 100 mg of drug substance. |
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Placebo Comparator: Placebo
4 capsules of placebo during 12 weeks
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Drug: Placebo oral tablet
Placebo capsules are filled with microcrystalline cellulose. |
Primary Outcome Measures :
- Platelet Response [ Time Frame: Up to week 12 ]Platelet count >= 30,000/µL and doubling the baseline (average of 2 previous counts)
Secondary Outcome Measures :
- Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to Discontinuation [ Time Frame: Up to week 16 ]
- Number of participants with vital sign abnormalities [ Time Frame: Up to week 16 ]
- Number of participants with 12-lead electrocardiogram (ECG) abnormalities [ Time Frame: Up to week 16 ]
- Number of participants with physical examination abnormalities [ Time Frame: Up to week 16 ]
- Number of participants with clinical laboratory abnormalities [ Time Frame: Up to week 16 ]
- Bleeding score [ Time Frame: Up to week 16 ]Measured by Immune thrombocytopenic purpura (ITP) bleeding score (Br. J. Haematol 2007;138(2): 245-8)
- Quality of Life score [ Time Frame: Up to week 16 ]Measured by the SF-36 score
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056195
Contacts
| Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information | please email | OSCOP2101ClinicalTrial.sm@ppdi.com | |
| Contact: First line of the email MUST contain the NCT# and Site# |
Locations
Show 27 study locations
Sponsors and Collaborators
Oscotec Inc.
Additional Information:
| Responsible Party: | Oscotec Inc. |
| ClinicalTrials.gov Identifier: | NCT04056195 |
| Other Study ID Numbers: |
OSCO-P2101 |
| First Posted: | August 14, 2019 Key Record Dates |
| Last Update Posted: | September 18, 2020 |
| Last Verified: | September 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Thrombocytopenia Immune System Diseases Purpura, Thrombocytopenic, Idiopathic Blood Platelet Disorders Hematologic Diseases Purpura, Thrombocytopenic Purpura |
Blood Coagulation Disorders Thrombotic Microangiopathies Hemorrhagic Disorders Autoimmune Diseases Hemorrhage Pathologic Processes Skin Manifestations |