A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04057118
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Oscotec Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Czechia, Poland, Russian Federation, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: SKI-O-703 100 mg

Experimental: SKI-O-703 200 mg

Experimental: SKI-O-703 400 mg

Placebo Comparator: Placebo

Interventions

Drug: - SKI-O-703

Oral administration, twice per day

Drug: - Placebo

Oral administration, twice per day

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Oscotec Investigational Site (Site 3110), Beverly Hills, California

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 3110)

Beverly Hills, California, 90211

Site Contact

Contact Site 3110 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 3105), Upland, California

Status

Recruiting

Address

Oscotec Investigational Site (Site 3105)

Upland, California, 91786

Site Contact

Contact Site 3105 (NCT 04057118)

[email protected]

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Oscotec Investigational (Site 3104), Miami Lakes, Florida

Status

Recruiting

Address

Oscotec Investigational (Site 3104)

Miami Lakes, Florida, 33014

Site Contact

Site 3104 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 3112), Tampa, Florida

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 3112)

Tampa, Florida, 33614

Site Contact

Contact Site 3112 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 3108), Lexington, Kentucky

Status

Recruiting

Address

Oscotec Investigational Site (Site 3108)

Lexington, Kentucky, 40504

Site Contact

Contact Site 3108 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 3102), Oklahoma City, Oklahoma

Status

Recruiting

Address

Oscotec Investigational Site (Site 3102)

Oklahoma City, Oklahoma, 73103

Site Contact

Contact Site 3102 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 3107), Duncansville, Pennsylvania

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 3107)

Duncansville, Pennsylvania, 16635

Site Contact

Contact Site 3107 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (3106), Carrollton, Texas

Status

Recruiting

Address

Oscotec Investigational Site (3106)

Carrollton, Texas, 75010

Site Contact

Contact Site 3106 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 3111), Houston, Texas

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 3111)

Houston, Texas, 77034

Site Contact

Contact Site 3111 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 3109), Mesquite, Texas

Status

Recruiting

Address

Oscotec Investigational Site (Site 3109)

Mesquite, Texas, 75150

Site Contact

Contact Site 3109 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 3103), San Antonio, Texas

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 3103)

San Antonio, Texas, 78229

Site Contact

Contact Site 3103 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 3101), Tomball, Texas

Status

Recruiting

Address

Oscotec Investigational Site (Site 3101)

Tomball, Texas, 77375

Site Contact

Site 3101 (NCT 04057118)

[email protected]

please email:

International Sites

Oscotec Investigational Site (Site 2101), Ostrava, Czechia

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 2101)

Ostrava, , 702 00

Site Contact

Contact Site 2101 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 2102), Zlín, Czechia

Status

Recruiting

Address

Oscotec Investigational Site (Site 2102)

Zlín, , 760 01

Site Contact

Contact Site 2102 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 2208), Wrocław, Dolnoslaskie, Poland

Status

Recruiting

Address

Oscotec Investigational Site (Site 2208)

Wrocław, Dolnoslaskie, 53-224

Site Contact

Contact Site 2208 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 2204), Bydgoszcz, Kujawsko-pomorskie, Poland

Status

Recruiting

Address

Oscotec Investigational Site (Site 2204)

Bydgoszcz, Kujawsko-pomorskie, 85-168

Site Contact

Contact Site 2204 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 2207), Lublin, Lubelskie, Poland

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 2207)

Lublin, Lubelskie, 20-582

Site Contact

Contact Site 2207 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 2202), Warszawa, Mazowieckie, Poland

Status

Recruiting

Address

Oscotec Investigational Site (Site 2202)

Warszawa, Mazowieckie, 01-518

Site Contact

Contact Site 2202 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 2201), Białystok, Podlaskie, Poland

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 2201)

Białystok, Podlaskie, 15-879

Site Contact

Contact Site 2201 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 2209), Ostrowiec Świętokrzyski, Swietokrzyskie, Poland

Status

Recruiting

Address

Oscotec Investigational Site (Site 2209)

Ostrowiec Świętokrzyski, Swietokrzyskie, 27-400

Site Contact

Contact Site 2209 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 2203), Poznań, Wielkopolskie, Poland

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 2203)

Poznań, Wielkopolskie, 61-397

Site Contact

Contact Site 2203 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 2206), Nadarzyn, Poland

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 2206)

Nadarzyn, , 05-830

Site Contact

Contact Site 2206 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 2307), Kemerovo, Russian Federation

Status

Recruiting

Address

Oscotec Investigational Site (Site 2307)

Kemerovo, , 650066

Site Contact

Contact Site 2307 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 2304), Moscow, Russian Federation

Status

Recruiting

Address

Oscotec Investigational Site (Site 2304)

Moscow, , 119049

Site Contact

Contact Site 2304 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 2305), Moscow, Russian Federation

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 2305)

Moscow, , 129110

Site Contact

Contact Site 2305 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 2308), Novosibirsk, Russian Federation

Status

Recruiting

Address

Oscotec Investigational Site (Site 2308)

Novosibirsk, , 630099

Site Contact

Site 2308 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 2306), Ryazan', Russian Federation

Status

Recruiting

Address

Oscotec Investigational Site (Site 2306)

Ryazan', , 390026

Site Contact

Contact Site 2306 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 2302), Saint Petersburg, Russian Federation

Status

Recruiting

Address

Oscotec Investigational Site (Site 2302)

Saint Petersburg, , 194291

Site Contact

Contact Site 2302 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 2303), Saint Petersburg, Russian Federation

Status

Recruiting

Address

Oscotec Investigational Site (Site 2303)

Saint Petersburg, , 196084

Site Contact

Site 2303 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 2303), Saint Petersburg, Russian Federation

Status

Recruiting

Address

Oscotec Investigational Site (Site 2303)

Saint Petersburg, , 196084

Site Contact

Contact Site 2303 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 2301), Tomsk, Russian Federation

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 2301)

Tomsk, , 634050

Site Contact

Contact Site 2301 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 2510), Ivano-Frankivs'k, Ivano-Frankivs'ka Oblast, Ukraine

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 2510)

Ivano-Frankivs'k, Ivano-Frankivs'ka Oblast, 76018

Site Contact

Contact Site 2510 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 2505), Ternopil', Ternopil's'ka Oblast', Ukraine

Status

Recruiting

Address

Oscotec Investigational Site (Site 2505)

Ternopil', Ternopil's'ka Oblast', 46002

Site Contact

Contact Site 2505 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 2506), Vinnytsia, Vinnyts'ka Oblast', Ukraine

Status

Recruiting

Address

Oscotec Investigational Site (Site 2506)

Vinnytsia, Vinnyts'ka Oblast', 21018

Site Contact

Contact Site 2506 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 2504), Vinnytsia, Vinnyts'ka Oblast', Ukraine

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 2504)

Vinnytsia, Vinnyts'ka Oblast', 21029

Site Contact

Contact Site 2504 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 2508), Kharkiv, Ukraine

Status

Recruiting

Address

Oscotec Investigational Site (Site 2508)

Kharkiv, , 61058

Site Contact

Contact Site 2508 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 2501), Kyiv, Ukraine

Status

Recruiting

Address

Oscotec Investigational Site (Site 2501)

Kyiv, , 01023

Site Contact

Contact Site 2501 (NCT 04057118)

[email protected]

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Oscotec Investigational Site (Site 2503), Kyiv, Ukraine

Status

Recruiting

Address

Oscotec Investigational Site (Site 2503)

Kyiv, , 04050

Site Contact

Site 2503 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 2502), Kyiv, Ukraine

Status

Not yet recruiting

Address

Oscotec Investigational Site (Site 2502)

Kyiv, , 4107

Site Contact

Contact Site 2502 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 2507), Poltava, Ukraine

Status

Recruiting

Address

Oscotec Investigational Site (Site 2507)

Poltava, , 36024

Site Contact

Contact Site 2507 (NCT 04057118)

[email protected]

please email:

Oscotec Investigational Site (Site 2509), Vinnytsia, Ukraine

Status

Recruiting

Address

Oscotec Investigational Site (Site 2509)

Vinnytsia, , 21009

Site Contact

Contact Site 2509 (NCT 04057118)

[email protected]

please email: