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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SKI-O-703 100 mg | Experimental |
| |
| SKI-O-703 200 mg | Experimental |
| |
| SKI-O-703 400 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKI-O-703 | Drug | Oral administration, twice per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disease Activity Score | 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). | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | 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) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria could apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oscotec Investigational Site (Site 3110) | Beverly Hills | California | 90211 | United States | ||
| Oscotec Investigational Site (Site 3105) |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Oral administration, twice per day |
| FG001 | SKI-O-703 100 mg | SKI-O-703: Oral administration, twice per day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2020 | Apr 3, 2024 |
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| Placebo | Drug | Oral administration, twice per day |
|
| Baseline and Weeks 2, 4 8 and 12 |
| • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | 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) | Baseline and Weeks 2, 4 8 and 12 |
| • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | 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) | Baseline and Weeks 2, 4 8 and 12 |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | 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. | Baseline and Weeks 2, 4 8 and 12 |
| Adverse Events (AEs) | Up to Week 16 |
| Serious Adverse Events (SAEs) | Up to Week 16 |
| Upland |
| California |
| 91786 |
| United States |
| Oscotec Investigational (Site 3104) | Miami Lakes | Florida | 33014 | United States |
| Oscotec Investigational Site (Site 3112) | Tampa | Florida | 33614 | United States |
| Oscotec Investigational Site (Site 3108) | Lexington | Kentucky | 40504 | United States |
| Oscotec Investigational Site (Site 3102) | Oklahoma City | Oklahoma | 73103 | United States |
| Oscotec Investigational Site (Site 3107) | Duncansville | Pennsylvania | 16635 | United States |
| Oscotec Investigational Site (3106) | Carrollton | Texas | 75010 | United States |
| Oscotec Investigational Site (Site 3111) | Houston | Texas | 77034 | United States |
| Oscotec Investigational Site (Site 3109) | Mesquite | Texas | 75150 | United States |
| Oscotec Investigational Site (Site 3103) | San Antonio | Texas | 78229 | United States |
| Oscotec Investigational Site (Site 3101) | Tomball | Texas | 77375 | United States |
| Oscotec Investigational Site (Site 2101) | Ostrava | 702 00 | Czechia |
| Oscotec Investigational Site (Site 2102) | Zlín | 760 01 | Czechia |
| Oscotec Investigational Site (Site 2203) | Poznan | Greater Poland Voivodeship | 61-397 | Poland |
| Oscotec Investigational Site (Site 2204) | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-168 | Poland |
| Oscotec Investigational Site (Site 2208) | Wroclaw | Lower Silesian Voivodeship | 53-224 | Poland |
| Oscotec Investigational Site (Site 2207) | Lublin | Lublin Voivodeship | 20-582 | Poland |
| Oscotec Investigational Site (Site 2202) | Warsaw | Masovian Voivodeship | 01-518 | Poland |
| Oscotec Investigational Site (Site 2201) | Bialystok | Podlaskie Voivodeship | 15-879 | Poland |
| Oscotec Investigational Site (Site 2206) | Nadarzyn | 05-830 | Poland |
| Oscotec Investigational Site (Site 2209) | Ostrowiec Świętokrzyski | Świętokrzyskie Voivodeship | 27-400 | Poland |
| Oscotec Investigational Site (Site 2307) | Kemerovo | 650066 | Russia |
| Oscotec Investigational Site (Site 2304) | Moscow | 119049 | Russia |
| Oscotec Investigational Site (Site 2305) | Moscow | 129110 | Russia |
| Oscotec Investigational Site (Site 2308) | Novosibirsk | 630099 | Russia |
| Oscotec Investigational Site (Site 2306) | Ryazan | 390026 | Russia |
| Oscotec Investigational Site (Site 2302) | Saint Petersburg | 194291 | Russia |
| Oscotec Investigational Site (Site 2303) | Saint Petersburg | 196084 | Russia |
| Oscotec Investigational Site (Site 2301) | Tomsk | 634050 | Russia |
| Oscotec Investigational Site (Site 2510) | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
| Oscotec Investigational Site (Site 2505) | Ternopil | Ternopil Oblast | 46002 | Ukraine |
| Oscotec Investigational Site (Site 2506) | Vinnytsia | Vinnytsia Oblast | 21018 | Ukraine |
| Oscotec Investigational Site (Site 2504) | Vinnytsia | Vinnytsia Oblast | 21029 | Ukraine |
| Oscotec Investigational Site (Site 2508) | Kharkiv | 61058 | Ukraine |
| Oscotec Investigational Site (Site 2501) | Kyiv | 01023 | Ukraine |
| Oscotec Investigational Site (Site 2503) | Kyiv | 04050 | Ukraine |
| Oscotec Investigational Site (Site 2502) | Kyiv | 4107 | Ukraine |
| Oscotec Investigational Site (Site 2507) | Poltava | 36024 | Ukraine |
| Oscotec Investigational Site (Site 2509) | Vinnytsia | 21009 | Ukraine |
| FG002 | SKI-O-703 200 mg | SKI-O-703: Oral administration, twice per day |
| FG003 | SKI-O-703 400 mg | SKI-O-703: Oral administration, twice per day |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Oral administration, twice per day |
| BG001 | SKI-O-703 100 mg | SKI-O-703: Oral administration, twice per day |
| BG002 | SKI-O-703 200 mg | SKI-O-703: Oral administration, twice per day |
| BG003 | SKI-O-703 400 mg | SKI-O-703: Oral administration, twice per day |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Height (cm) | Mean | Standard Deviation | centimeter |
| |||||||||||||||
| Weight (kg) | Mean | Standard Deviation | kilogram |
| |||||||||||||||
| Body mass index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Time since RA onset (years) | Mean | Standard Deviation | years |
| |||||||||||||||
| Nicotine use | Count of Participants | Participants |
| ||||||||||||||||
| Alcohol history | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Disease Activity Score | 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). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | 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) | The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data. | Posted | Count of Participants | Participants | Baseline and Weeks 2, 4 8 and 12 |
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| Secondary | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | 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) | The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data. | Posted | Count of Participants | Participants | Baseline and Weeks 2, 4 8 and 12 |
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| Secondary | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | 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) | The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data. | Posted | Count of Participants | Participants | Baseline and Weeks 2, 4 8 and 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | 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. | The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Weeks 2, 4 8 and 12 |
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| Secondary | Adverse Events (AEs) | Posted | Count of Participants | Participants | Up to Week 16 |
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| Secondary | Serious Adverse Events (SAEs) | Posted | Count of Participants | Participants | Up to Week 16 |
|
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16 weeks
At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: Oral administration, twice per day | 0 | 41 | 1 | 41 | 8 | 41 |
| EG001 | SKI-O-703 100 mg | SKI-O-703: Oral administration, twice per day | 0 | 41 | 1 | 41 | 6 | 41 |
| EG002 | SKI-O-703 200 mg | SKI-O-703: Oral administration, twice per day | 0 | 40 | 0 | 40 | 10 | 40 |
| EG003 | SKI-O-703 400 mg | SKI-O-703: Oral administration, twice per day | 0 | 41 | 1 | 41 | 13 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Systematic Assessment |
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| Myocarditis | Cardiac disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA Version 21.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA Version 21.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sungsil Lee/Team Leader of Clinical Development | Oscotec Inc. | +82316287624 | sslee@oscotec.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2020 | Feb 14, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000728456 | cevidoplenib |
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| Greater than 65 to less than 75 years old |
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| 75 years old or greater |
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| Male |
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| Black or African-American |
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| Asian |
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| American-Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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| Prior smoker or user |
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| Current smoker or user |
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| Prior drinker, but no longer a drinker |
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| Current drinker |
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SKI-O-703: Oral administration, twice per day |
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SKI-O-703: Oral administration, twice per day |
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SKI-O-703: Oral administration, twice per day |
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| OG003 |
| SKI-O-703 400 mg |
SKI-O-703: Oral administration, twice per day |
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