A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.
- Registration Number
- NCT04057118
- Lead Sponsor
- Oscotec Inc.
- Brief Summary
This study will evaluate the safety and efficacy of SKI-O-703 compared with placebo, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying agents. Patients will be randomly assigned to one of 4 groups and will receive one of three doses of SKI-O-703 or placebo, administered orally twice daily for 12 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
- Patients must provide written, signed, informed consent.
- 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 receiving oral agents, except for medications listed in inclusion criteria for the treatment of RA.
- 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.
Other protocol-defined inclusion/exclusion criteria could apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SKI-O-703 100 mg SKI-O-703 - SKI-O-703 200 mg SKI-O-703 - Placebo Placebo - SKI-O-703 400 mg SKI-O-703 -
- Primary Outcome Measures
Name Time Method Change in Disease Activity Score Baseline and Week 12 Mean change from baseline in disease activity score for 28 joints (DAS28) using hsCRP (high sensitivity C-reactive protein).
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), and high sensitivity C-reactive protein (hsCRP) (milligrams per liter). DAS28 was calculated using following formula: DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(hsCRP+1)\*1.10+1.15.
High DAS28-hsCRP value indicates more severe disease activity, by value of \>5.1 indicating relatively high disease activity, whereas value of \<3.2 indicating achieved lower disease activity (no theoretical full range available).
- Secondary Outcome Measures
Name Time Method Adverse Events (AEs) Up to Week 16 • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score Baseline and Weeks 2, 4 8 and 12 ACR20 score is the percentage of patients showing ≥20% improvement from baseline in tender joint count (68 joint counts), ≥20% improvement in swollen joint count (66 joint counts), and ≥20% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)
Serious Adverse Events (SAEs) Up to Week 16 • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score Baseline and Weeks 2, 4 8 and 12 ACR70 score is the percentage of patients showing ≥70% improvement from baseline in tender joint count (68 joint counts), ≥70% improvement in swollen joint count (66 joint counts), and ≥70% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)
• Percentage of Patients With ACR50 (American College of Rheumatology 50) Score Baseline and Weeks 2, 4 8 and 12 ACR50 score is the percentage of patients showing ≥50% improvement from baseline in tender joint count (68 joint counts), ≥50% improvement in swollen joint count (66 joint counts), and ≥50% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Baseline and Weeks 2, 4 8 and 12 Change from baseline measured by disability index
The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a subject-reported questionnaire that is commonly used to measure the disease associated disability. It consists of 8 sections which are dressing or grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities.
Scores for each functional area were averaged to calculate HAQ-DI scores, ranging from 0 (no disability) to 3 (worst disability), higher score showing more disability.
A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Trial Locations
- Locations (40)
Oscotec Investigational Site (Site 3111)
🇺🇸Houston, Texas, United States
Oscotec Investigational Site (Site 3101)
🇺🇸Tomball, Texas, United States
Oscotec Investigational Site (Site 2302)
🇷🇺Saint Petersburg, Russian Federation
Oscotec Investigational Site (Site 2208)
🇵🇱Wrocław, Dolnoslaskie, Poland
Oscotec Investigational Site (Site 2503)
🇺🇦Kyiv, Ukraine
Oscotec Investigational Site (Site 2209)
🇵🇱Ostrowiec Świętokrzyski, Swietokrzyskie, Poland
Oscotec Investigational Site (Site 2206)
🇵🇱Nadarzyn, Poland
Oscotec Investigational Site (Site 2505)
🇺🇦Ternopil', Ternopil's'ka Oblast', Ukraine
Oscotec Investigational Site (Site 2304)
🇷🇺Moscow, Russian Federation
Oscotec Investigational Site (Site 3110)
🇺🇸Beverly Hills, California, United States
Oscotec Investigational Site (Site 3105)
🇺🇸Upland, California, United States
Oscotec Investigational Site (Site 3102)
🇺🇸Oklahoma City, Oklahoma, United States
Oscotec Investigational Site (Site 3109)
🇺🇸Mesquite, Texas, United States
Oscotec Investigational Site (3106)
🇺🇸Carrollton, Texas, United States
Oscotec Investigational Site (Site 3103)
🇺🇸San Antonio, Texas, United States
Oscotec Investigational Site (Site 2102)
🇨🇿Zlín, Czechia
Oscotec Investigational Site (Site 2101)
🇨🇿Ostrava, Czechia
Oscotec Investigational Site (Site 2202)
🇵🇱Warszawa, Mazowieckie, Poland
Oscotec Investigational Site (Site 2207)
🇵🇱Lublin, Lubelskie, Poland
Oscotec Investigational Site (Site 2203)
🇵🇱Poznań, Wielkopolskie, Poland
Oscotec Investigational Site (Site 2307)
🇷🇺Kemerovo, Russian Federation
Oscotec Investigational Site (Site 2308)
🇷🇺Novosibirsk, Russian Federation
Oscotec Investigational Site (Site 2305)
🇷🇺Moscow, Russian Federation
Oscotec Investigational Site (Site 2306)
🇷🇺Ryazan', Russian Federation
Oscotec Investigational Site (Site 2510)
🇺🇦Ivano-Frankivs'k, Ivano-Frankivs'ka Oblast, Ukraine
Oscotec Investigational Site (Site 2303)
🇷🇺Saint Petersburg, Russian Federation
Oscotec Investigational Site (Site 2301)
🇷🇺Tomsk, Russian Federation
Oscotec Investigational Site (Site 2506)
🇺🇦Vinnytsia, Vinnyts'ka Oblast', Ukraine
Oscotec Investigational Site (Site 2504)
🇺🇦Vinnytsia, Vinnyts'ka Oblast', Ukraine
Oscotec Investigational Site (Site 2502)
🇺🇦Kyiv, Ukraine
Oscotec Investigational Site (Site 2508)
🇺🇦Kharkiv, Ukraine
Oscotec Investigational Site (Site 2501)
🇺🇦Kyiv, Ukraine
Oscotec Investigational Site (Site 2507)
🇺🇦Poltava, Ukraine
Oscotec Investigational Site (Site 2509)
🇺🇦Vinnytsia, Ukraine
Oscotec Investigational Site (Site 3112)
🇺🇸Tampa, Florida, United States
Oscotec Investigational Site (Site 3107)
🇺🇸Duncansville, Pennsylvania, United States
Oscotec Investigational Site (Site 3108)
🇺🇸Lexington, Kentucky, United States
Oscotec Investigational (Site 3104)
🇺🇸Miami Lakes, Florida, United States
Oscotec Investigational Site (Site 2201)
🇵🇱Białystok, Podlaskie, Poland
Oscotec Investigational Site (Site 2204)
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland