Clinical trial NCT04057118: A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Oscotec Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-15
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Disease Activity Score
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score
timeFrame: Baseline and Weeks 2, 4 8 and 12
measure: • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score
timeFrame: Baseline and Weeks 2, 4 8 and 12
measure: • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score
timeFrame: Baseline and Weeks 2, 4 8 and 12
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Baseline and Weeks 2, 4 8 and 12
measure: Adverse Events (AEs)
timeFrame: Up to Week 16
measure: Serious Adverse Events (SAEs)
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Oscotec Investigational Site (Site 3110)
state: California
city: Upland
country: United States
facility: Oscotec Investigational Site (Site 3105)
state: California
city: Miami Lakes
country: United States
facility: Oscotec Investigational (Site 3104)
state: Florida
city: Tampa
country: United States
facility: Oscotec Investigational Site (Site 3112)
state: Florida
city: Lexington
country: United States
facility: Oscotec Investigational Site (Site 3108)
state: Kentucky
city: Oklahoma City
country: United States
facility: Oscotec Investigational Site (Site 3102)
state: Oklahoma
city: Duncansville
country: United States
facility: Oscotec Investigational Site (Site 3107)
state: Pennsylvania
city: Carrollton
country: United States
facility: Oscotec Investigational Site (3106)
state: Texas
city: Houston
country: United States
facility: Oscotec Investigational Site (Site 3111)
state: Texas
city: Mesquite
country: United States
facility: Oscotec Investigational Site (Site 3109)
state: Texas
city: San Antonio
country: United States
facility: Oscotec Investigational Site (Site 3103)
state: Texas
city: Tomball
country: United States
facility: Oscotec Investigational Site (Site 3101)
state: Texas
city: Ostrava
country: Czechia
facility: Oscotec Investigational Site (Site 2101)
city: Zlín
country: Czechia
facility: Oscotec Investigational Site (Site 2102)
city: Wrocław
country: Poland
facility: Oscotec Investigational Site (Site 2208)
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Oscotec Investigational Site (Site 2204)
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Oscotec Investigational Site (Site 2207)
state: Lubelskie
city: Warszawa
country: Poland
facility: Oscotec Investigational Site (Site 2202)
state: Mazowieckie
city: Białystok
country: Poland
facility: Oscotec Investigational Site (Site 2201)
state: Podlaskie
city: Ostrowiec Świętokrzyski
country: Poland
facility: Oscotec Investigational Site (Site 2209)
state: Swietokrzyskie
city: Poznań
country: Poland
facility: Oscotec Investigational Site (Site 2203)
state: Wielkopolskie
city: Nadarzyn
country: Poland
facility: Oscotec Investigational Site (Site 2206)
city: Kemerovo
country: Russian Federation
facility: Oscotec Investigational Site (Site 2307)
city: Moscow
country: Russian Federation
facility: Oscotec Investigational Site (Site 2304)
city: Moscow
country: Russian Federation
facility: Oscotec Investigational Site (Site 2305)
city: Novosibirsk
country: Russian Federation
facility: Oscotec Investigational Site (Site 2308)
city: Ryazan'
country: Russian Federation
facility: Oscotec Investigational Site (Site 2306)
city: Saint Petersburg
country: Russian Federation
facility: Oscotec Investigational Site (Site 2302)
city: Saint Petersburg
country: Russian Federation
facility: Oscotec Investigational Site (Site 2303)
city: Tomsk
country: Russian Federation
facility: Oscotec Investigational Site (Site 2301)
city: Ivano-Frankivs'k
country: Ukraine
facility: Oscotec Investigational Site (Site 2510)
state: Ivano-Frankivs'ka Oblast
city: Ternopil'
country: Ukraine
facility: Oscotec Investigational Site (Site 2505)
state: Ternopil's'ka Oblast'
city: Vinnytsia
country: Ukraine
facility: Oscotec Investigational Site (Site 2506)
state: Vinnyts'ka Oblast'
city: Vinnytsia
country: Ukraine
facility: Oscotec Investigational Site (Site 2504)
state: Vinnyts'ka Oblast'
city: Kharkiv
country: Ukraine
facility: Oscotec Investigational Site (Site 2508)
city: Kyiv
country: Ukraine
facility: Oscotec Investigational Site (Site 2501)
city: Kyiv
country: Ukraine
facility: Oscotec Investigational Site (Site 2503)
city: Kyiv
country: Ukraine
facility: Oscotec Investigational Site (Site 2502)
city: Poltava
country: Ukraine
facility: Oscotec Investigational Site (Site 2507)
city: Vinnytsia
country: Ukraine
facility: Oscotec Investigational Site (Site 2509)
Study officials:
References: