A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.
NCT ID: NCT04057118
Last Updated: 2024-07-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
163 participants
INTERVENTIONAL
2019-03-20
2020-10-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SKI-O-703 100 mg
SKI-O-703
Oral administration, twice per day
SKI-O-703 200 mg
SKI-O-703
Oral administration, twice per day
SKI-O-703 400 mg
SKI-O-703
Oral administration, twice per day
Placebo
Placebo
Oral administration, twice per day
Interventions
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SKI-O-703
Oral administration, twice per day
Placebo
Oral administration, twice per day
Eligibility Criteria
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Inclusion Criteria
* Patients must have a diagnosis of Rheumatoid Arthritis (RA) according to American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism classification, for at least 6 months prior to first administration of study drug.
* Patients must have active RA at screening and baseline (Day 1 of the study).
* Patients who have active disease despite csDMARD (conventional synthetic disease-modifying antirheumatic drugs) therapy for at least 3 months prior to Day 1 of the study.
* Patients must have had an inadequate response to previous anti-TNF⍺ (anti-tumor necrosis factor alpha) biological agent(s) for the treatment of RA and meet the washout period prior to Day 1 of the study.
* Patients who have previously received any other or biological agent for the treatment of RA, other than anti-TNF⍺ inhibitor(s).
* Patients who have a current or past history of hepatitis B virus (HBV) infection; positive test for hepatitis C virus (HCV) antibody; positive test for human immunodeficiency virus (HIV); history of or concurrent interstitial pneumonia; acute infection requiring oral antibiotics within 2 weeks, or parenteral injection of antibiotics within 4 weeks prior to first administration of the study drug; other serious infection within 6 months prior to first administration of study drug; recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to first administration of the study drug; past or current granulomatous infections or other severe or chronic infection; positive test for tuberculosis (TB) or other evidence of TB.
* Patients with uncontrolled diabetes mellitus, or uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg).
* Patients with any other inflammatory or rheumatic diseases that could impact the evaluation of the effect of the study drug.
* Patients with a history of malignancy within 5 years prior to first administration of the study drug, except completely excised and cured squamous cell carcinoma, carcinoma of the cervix in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
* New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease or heart attack within 6 months prior to first administration of the study drug.
* Female patients who are currently pregnant, breastfeeding or planning to become pregnant or breastfeed within 6 months of the last dose of the study drug.
18 Years
ALL
No
Sponsors
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Oscotec Inc.
INDUSTRY
Responsible Party
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Locations
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Oscotec Investigational Site (Site 3110)
Beverly Hills, California, United States
Oscotec Investigational Site (Site 3105)
Upland, California, United States
Oscotec Investigational (Site 3104)
Miami Lakes, Florida, United States
Oscotec Investigational Site (Site 3112)
Tampa, Florida, United States
Oscotec Investigational Site (Site 3108)
Lexington, Kentucky, United States
Oscotec Investigational Site (Site 3102)
Oklahoma City, Oklahoma, United States
Oscotec Investigational Site (Site 3107)
Duncansville, Pennsylvania, United States
Oscotec Investigational Site (3106)
Carrollton, Texas, United States
Oscotec Investigational Site (Site 3111)
Houston, Texas, United States
Oscotec Investigational Site (Site 3109)
Mesquite, Texas, United States
Oscotec Investigational Site (Site 3103)
San Antonio, Texas, United States
Oscotec Investigational Site (Site 3101)
Tomball, Texas, United States
Oscotec Investigational Site (Site 2101)
Ostrava, , Czechia
Oscotec Investigational Site (Site 2102)
Zlín, , Czechia
Oscotec Investigational Site (Site 2203)
Poznan, Greater Poland Voivodeship, Poland
Oscotec Investigational Site (Site 2204)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Oscotec Investigational Site (Site 2208)
Wroclaw, Lower Silesian Voivodeship, Poland
Oscotec Investigational Site (Site 2207)
Lublin, Lublin Voivodeship, Poland
Oscotec Investigational Site (Site 2202)
Warsaw, Masovian Voivodeship, Poland
Oscotec Investigational Site (Site 2201)
Bialystok, Podlaskie Voivodeship, Poland
Oscotec Investigational Site (Site 2206)
Nadarzyn, , Poland
Oscotec Investigational Site (Site 2209)
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Oscotec Investigational Site (Site 2307)
Kemerovo, , Russia
Oscotec Investigational Site (Site 2304)
Moscow, , Russia
Oscotec Investigational Site (Site 2305)
Moscow, , Russia
Oscotec Investigational Site (Site 2308)
Novosibirsk, , Russia
Oscotec Investigational Site (Site 2306)
Ryazan, , Russia
Oscotec Investigational Site (Site 2302)
Saint Petersburg, , Russia
Oscotec Investigational Site (Site 2303)
Saint Petersburg, , Russia
Oscotec Investigational Site (Site 2301)
Tomsk, , Russia
Oscotec Investigational Site (Site 2510)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Oscotec Investigational Site (Site 2505)
Ternopil, Ternopil Oblast, Ukraine
Oscotec Investigational Site (Site 2506)
Vinnytsia, Vinnytsia Oblast, Ukraine
Oscotec Investigational Site (Site 2504)
Vinnytsia, Vinnytsia Oblast, Ukraine
Oscotec Investigational Site (Site 2508)
Kharkiv, , Ukraine
Oscotec Investigational Site (Site 2501)
Kyiv, , Ukraine
Oscotec Investigational Site (Site 2503)
Kyiv, , Ukraine
Oscotec Investigational Site (Site 2502)
Kyiv, , Ukraine
Oscotec Investigational Site (Site 2507)
Poltava, , Ukraine
Oscotec Investigational Site (Site 2509)
Vinnytsia, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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OSCO-P2201
Identifier Type: -
Identifier Source: org_study_id
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