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)

Sponsors

Lead Sponsor: Oscotec Inc.

Source Oscotec Inc.
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.

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.

Overall Status Recruiting
Start Date October 11, 2019
Completion Date February 2021
Primary Completion Date February 2021
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Platelet Response Up to week 12
Secondary Outcome
Measure Time Frame
Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to Discontinuation Up to week 16
Number of participants with vital sign abnormalities Up to week 16
Number of participants with 12-lead electrocardiogram (ECG) abnormalities Up to week 16
Number of participants with physical examination abnormalities Up to week 16
Number of participants with clinical laboratory abnormalities Up to week 16
Bleeding score Up to week 16
Quality of Life score Up to week 16
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: SKI-O-703

Description: The SKI-O-703 capsules will contain 100 mg of drug substance.

Intervention Type: Drug

Intervention Name: Placebo oral tablet

Description: Placebo capsules are filled with microcrystalline cellulose.

Eligibility

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information

Phone: please email

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup:
University of Southern California, 1441 Eastlake Ave. | Los Angeles, California, 90033, United States Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Duke University Medical Center, 2301 Erwin Road | Durham, North Carolina, 22705, United States Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
East Carolina University, 600 Moye Boulevard | Greenville, North Carolina, 27834, United States Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
The Cleveland Clinic Foundation, 9500 Euclid Avenue | Cleveland, Ohio, 44195, United States Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
University General Hospital of Patras, Department of Internal Medicine, Hematology Division, Rio Patra | Patras, Achaia, 26500, Greece Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Laiko General Hsoptial of Athens, 16 Sevastoupoleos Street | Athens, Attiki, 11526, Greece Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
University Hospital of Larissa, Mezourlo | Larissa, 41110, Greece Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
AHEPA University General Hospital of Thessaloniki, Kyriakidi Stilponos 1 | Thessaloníki, 54636, Greece Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Hippokration Hospital, Konstantinoupoleos 49 | Thessaloníki, 54642, Greece Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Georgios Papanikolaou General Hospital of Thessaloniki, Exohi | Thessaloníki, 57010, Greece Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Ajou University Hospital, 164 World Cup-ro, Yeongtong-gu | Suwon-si, Gyeonggido, 16499, Korea, Republic of Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Asan Medical Center - PPDS, 88 Olympic-ro 43-gil, Songpa-gu | Seoul, 5505, Korea, Republic of Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Samsung Medical Center PPDS, 81 Irwon-dong Gangnam-gu | Seoul, 6351, Korea, Republic of Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Seoul National University Hospital, 101 Daehak-ro, Jongno-gu | Soeul, 3080, Korea, Republic of Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Severance Hospital Yonsei University Health System, 50-1 Yonsei-Ro, Seodaemun-Gu | Soeul, 3722, Korea, Republic of Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Ujejskiego 75 | Bydgoszcz, 85-168, Poland Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii, Smoluchowskiego 17 | Gdańsk, 80-214, Poland Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii, Aleja Zwyciestwa 31/32 | Gdańsk, 80-219, Poland Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
EMC Instytut Medyczny S.A Przychondnia przy Łowieckiej, Łowiecka | Wrocław, Poland Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Hospital Universitario Quironsalud Madrid, Calle Diego De Velazquez 1 | Pozuelo De Alarcón, Madrid, 28223, Spain Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Hospital Universitario Ramon y Cajal, Carretera de Colmenar Viejo Km. 9100 | Madrid, 28034, Spain Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Hospital Universitario 12 de Octubre, Avenida de Cordoba, s/n | Madrid, 28041, Spain Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Hospital Universitario La Paz, Paseo Castellana 261 | Madrid, 28046, Spain Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Hosptial Regional Universitario de Malaga - Hospital General, Avenida Carlos Haya, s/n | Málaga, 29010, Spain Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Complejo Asistencial Universitario de Salamanca - H. Clinico, Paseo de San Vincent, 58 | Salamanca, 37007, Spain Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Hospital Universitario Virgen del Rocio, Avenida Manuel Siurot, Centro de Diagnostico y Tratamiento | Sevilla, 41013, Spain Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Hospital Universitari i Politecnic La Fe de Valencia, Avda Fernando Abril Martorell no° 106 | Valencia, 46026, Spain Recruiting If interested in participating at this site, enter site name and NCT 04056195 in subject line of email and send to [email protected]
Location Countries

Greece

Korea, Republic of

Poland

Spain

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: SKI-O-703 200 mg

Type: Experimental

Description: 2 capsules of 100 mg SKI-O-703 BID (twice a day) 12 hours apart + 2 capsules of placebo during 12 weeks

Label: SKI-O-703 400 mg

Type: Experimental

Description: 4 capsules of 100 mg SKI-O-703 + 0 capsules of placebo during 12 weeks

Label: Placebo

Type: Placebo Comparator

Description: 4 capsules of placebo during 12 weeks

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov