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

Rheumatoid Arthritis Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04057118
• Other study ID #: OSCO-P2201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 20, 2019
• Est. completion date: October 2020

Study information

• Verified date: September 2020
• Source: Oscotec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• SKI-O-703
Oral administration, twice per day
• Placebo
Oral administration, twice per day

Locations

Country	Name	City	State
Czechia	Oscotec Investigational Site (Site 2101)	Ostrava
Czechia	Oscotec Investigational Site (Site 2102)	Zlín
Poland	Oscotec Investigational Site (Site 2201)	Bialystok	Podlaskie
Poland	Oscotec Investigational Site (Site 2204)	Bydgoszcz	Kujawsko-pomorskie
Poland	Oscotec Investigational Site (Site 2207)	Lublin	Lubelskie
Poland	Oscotec Investigational Site (Site 2206)	Nadarzyn
Poland	Oscotec Investigational Site (Site 2209)	Ostrowiec Swietokrzyski	Swietokrzyskie
Poland	Oscotec Investigational Site (Site 2203)	Poznan	Wielkopolskie
Poland	Oscotec Investigational Site (Site 2202)	Warszawa	Mazowieckie
Poland	Oscotec Investigational Site (Site 2208)	Wroclaw	Dolnoslaskie
Russian Federation	Oscotec Investigational Site (Site 2307)	Kemerovo
Russian Federation	Oscotec Investigational Site (Site 2304)	Moscow
Russian Federation	Oscotec Investigational Site (Site 2305)	Moscow
Russian Federation	Oscotec Investigational Site (Site 2308)	Novosibirsk
Russian Federation	Oscotec Investigational Site (Site 2306)	Ryazan'
Russian Federation	Oscotec Investigational Site (Site 2302)	Saint Petersburg
Russian Federation	Oscotec Investigational Site (Site 2303)	Saint Petersburg
Russian Federation	Oscotec Investigational Site (Site 2301)	Tomsk
Ukraine	Oscotec Investigational Site (Site 2510)	Ivano-Frankivs'k	Ivano-Frankivs'ka Oblast
Ukraine	Oscotec Investigational Site (Site 2508)	Kharkiv
Ukraine	Oscotec Investigational Site (Site 2501)	Kyiv
Ukraine	Oscotec Investigational Site (Site 2502)	Kyiv
Ukraine	Oscotec Investigational Site (Site 2503)	Kyiv
Ukraine	Oscotec Investigational Site (Site 2507)	Poltava
Ukraine	Oscotec Investigational Site (Site 2505)	Ternopil'	Ternopil's'ka Oblast'
Ukraine	Oscotec Investigational Site (Site 2504)	Vinnytsia	Vinnyts'ka Oblast'
Ukraine	Oscotec Investigational Site (Site 2506)	Vinnytsia	Vinnyts'ka Oblast'
Ukraine	Oscotec Investigational Site (Site 2509)	Vinnytsia
United States	Oscotec Investigational Site (Site 3110)	Beverly Hills	California
United States	Oscotec Investigational Site (3106)	Carrollton	Texas
United States	Oscotec Investigational Site (Site 3107)	Duncansville	Pennsylvania
United States	Oscotec Investigational Site (Site 3111)	Houston	Texas
United States	Oscotec Investigational Site (Site 3108)	Lexington	Kentucky
United States	Oscotec Investigational Site (Site 3109)	Mesquite	Texas
United States	Oscotec Investigational (Site 3104)	Miami Lakes	Florida
United States	Oscotec Investigational Site (Site 3102)	Oklahoma City	Oklahoma
United States	Oscotec Investigational Site (Site 3103)	San Antonio	Texas
United States	Oscotec Investigational Site (Site 3112)	Tampa	Florida
United States	Oscotec Investigational Site (Site 3101)	Tomball	Texas
United States	Oscotec Investigational Site (Site 3105)	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Oscotec Inc.

Countries where clinical trial is conducted

United States,  Czechia,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	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)	Baseline and Weeks 2, 4 8 and 12
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)	Baseline and Weeks 2, 4 8 and 12
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)	Baseline and Weeks 2, 4 8 and 12
Secondary	Health Assessment Questionnaire-Disability Index (HAQ-DI) score	Change from baseline measured by disability index	Baseline and Weeks 2, 4 8 and 12
Secondary	Incidence of Adverse Events (AEs)		Up to Week 16
Secondary	Incidence of Serious Adverse Events (SAEs)		Up to Week 16

External Links

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