A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SKI-O-703 100 mg
|
Drug: SKI-O-703
Oral administration, twice per day
|
| Experimental: SKI-O-703 200 mg
|
Drug: SKI-O-703
Oral administration, twice per day
|
| Experimental: SKI-O-703 400 mg
|
Drug: SKI-O-703
Oral administration, twice per day
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Oral administration, twice per day
|
Outcome Measures
Primary Outcome Measures
- 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)
Secondary Outcome Measures
- • 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)
- • 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)
- • 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)
- Health Assessment Questionnaire-Disability Index (HAQ-DI) score [Baseline and Weeks 2, 4 8 and 12]
Change from baseline measured by disability index
- Incidence of Adverse Events (AEs) [Up to Week 16]
- Incidence of Serious Adverse Events (SAEs) [Up to Week 16]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oscotec Investigational Site (Site 3110) | Beverly Hills | California | United States | 90211 |
| 2 | Oscotec Investigational Site (Site 3105) | Upland | California | United States | 91786 |
| 3 | Oscotec Investigational (Site 3104) | Miami Lakes | Florida | United States | 33014 |
| 4 | Oscotec Investigational Site (Site 3112) | Tampa | Florida | United States | 33614 |
| 5 | Oscotec Investigational Site (Site 3108) | Lexington | Kentucky | United States | 40504 |
| 6 | Oscotec Investigational Site (Site 3102) | Oklahoma City | Oklahoma | United States | 73103 |
| 7 | Oscotec Investigational Site (Site 3107) | Duncansville | Pennsylvania | United States | 16635 |
| 8 | Oscotec Investigational Site (3106) | Carrollton | Texas | United States | 75010 |
| 9 | Oscotec Investigational Site (Site 3111) | Houston | Texas | United States | 77034 |
| 10 | Oscotec Investigational Site (Site 3109) | Mesquite | Texas | United States | 75150 |
| 11 | Oscotec Investigational Site (Site 3103) | San Antonio | Texas | United States | 78229 |
| 12 | Oscotec Investigational Site (Site 3101) | Tomball | Texas | United States | 77375 |
| 13 | Oscotec Investigational Site (Site 2101) | Ostrava | Czechia | 702 00 | |
| 14 | Oscotec Investigational Site (Site 2102) | Zlín | Czechia | 760 01 | |
| 15 | Oscotec Investigational Site (Site 2208) | Wrocław | Dolnoslaskie | Poland | 53-224 |
| 16 | Oscotec Investigational Site (Site 2204) | Bydgoszcz | Kujawsko-pomorskie | Poland | 85-168 |
| 17 | Oscotec Investigational Site (Site 2207) | Lublin | Lubelskie | Poland | 20-582 |
| 18 | Oscotec Investigational Site (Site 2202) | Warszawa | Mazowieckie | Poland | 01-518 |
| 19 | Oscotec Investigational Site (Site 2201) | Białystok | Podlaskie | Poland | 15-879 |
| 20 | Oscotec Investigational Site (Site 2209) | Ostrowiec Świętokrzyski | Swietokrzyskie | Poland | 27-400 |
| 21 | Oscotec Investigational Site (Site 2203) | Poznań | Wielkopolskie | Poland | 61-397 |
| 22 | Oscotec Investigational Site (Site 2206) | Nadarzyn | Poland | 05-830 | |
| 23 | Oscotec Investigational Site (Site 2307) | Kemerovo | Russian Federation | 650066 | |
| 24 | Oscotec Investigational Site (Site 2304) | Moscow | Russian Federation | 119049 | |
| 25 | Oscotec Investigational Site (Site 2305) | Moscow | Russian Federation | 129110 | |
| 26 | Oscotec Investigational Site (Site 2308) | Novosibirsk | Russian Federation | 630099 | |
| 27 | Oscotec Investigational Site (Site 2306) | Ryazan' | Russian Federation | 390026 | |
| 28 | Oscotec Investigational Site (Site 2302) | Saint Petersburg | Russian Federation | 194291 | |
| 29 | Oscotec Investigational Site (Site 2303) | Saint Petersburg | Russian Federation | 196084 | |
| 30 | Oscotec Investigational Site (Site 2301) | Tomsk | Russian Federation | 634050 | |
| 31 | Oscotec Investigational Site (Site 2510) | Ivano-Frankivs'k | Ivano-Frankivs'ka Oblast | Ukraine | 76018 |
| 32 | Oscotec Investigational Site (Site 2505) | Ternopil' | Ternopil's'ka Oblast' | Ukraine | 46002 |
| 33 | Oscotec Investigational Site (Site 2506) | Vinnytsia | Vinnyts'ka Oblast' | Ukraine | 21018 |
| 34 | Oscotec Investigational Site (Site 2504) | Vinnytsia | Vinnyts'ka Oblast' | Ukraine | 21029 |
| 35 | Oscotec Investigational Site (Site 2508) | Kharkiv | Ukraine | 61058 | |
| 36 | Oscotec Investigational Site (Site 2501) | Kyiv | Ukraine | 01023 | |
| 37 | Oscotec Investigational Site (Site 2503) | Kyiv | Ukraine | 04050 | |
| 38 | Oscotec Investigational Site (Site 2502) | Kyiv | Ukraine | 4107 | |
| 39 | Oscotec Investigational Site (Site 2507) | Poltava | Ukraine | 36024 | |
| 40 | Oscotec Investigational Site (Site 2509) | Vinnytsia | Ukraine | 21009 |
Sponsors and Collaborators
- Oscotec Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- OSCO-P2201