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

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

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: SKI-O-703; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 148
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Ostrava, Czechia, 702 00
    • Oscotec Investigational Site (Site 2101)
  • Zlín, Czechia, 760 01
    • Oscotec Investigational Site (Site 2102)
• Poland
  • Nadarzyn, Poland, 05-830
    • Oscotec Investigational Site (Site 2206)
  • Dolnoslaskie
    • Wrocław, Dolnoslaskie, Poland, 53-224
      • Oscotec Investigational Site (Site 2208)
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
      • Oscotec Investigational Site (Site 2204)
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-582
      • Oscotec Investigational Site (Site 2207)
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 01-518
      • Oscotec Investigational Site (Site 2202)
  • Podlaskie
    • Białystok, Podlaskie, Poland, 15-879
      • Oscotec Investigational Site (Site 2201)
  • Swietokrzyskie
    • Ostrowiec Świętokrzyski, Swietokrzyskie, Poland, 27-400
      • Oscotec Investigational Site (Site 2209)
  • Wielkopolskie
    • Poznań, Wielkopolskie, Poland, 61-397
      • Oscotec Investigational Site (Site 2203)
• Russian Federation
  • Kemerovo, Russian Federation, 650066
    • Oscotec Investigational Site (Site 2307)
  • Moscow, Russian Federation, 119049
    • Oscotec Investigational Site (Site 2304)
  • Moscow, Russian Federation, 129110
    • Oscotec Investigational Site (Site 2305)
  • Novosibirsk, Russian Federation, 630099
    • Oscotec Investigational Site (Site 2308)
  • Ryazan', Russian Federation, 390026
    • Oscotec Investigational Site (Site 2306)
  • Saint Petersburg, Russian Federation, 194291
    • Oscotec Investigational Site (Site 2302)
  • Saint Petersburg, Russian Federation, 196084
    • Oscotec Investigational Site (Site 2303)
  • Tomsk, Russian Federation, 634050
    • Oscotec Investigational Site (Site 2301)
• Ukraine
  • Kharkiv, Ukraine, 61058
    • Oscotec Investigational Site (Site 2508)
  • Kyiv, Ukraine, 01023
    • Oscotec Investigational Site (Site 2501)
  • Kyiv, Ukraine, 04050
    • Oscotec Investigational Site (Site 2503)
  • Kyiv, Ukraine, 4107
    • Oscotec Investigational Site (Site 2502)
  • Poltava, Ukraine, 36024
    • Oscotec Investigational Site (Site 2507)
  • Vinnytsia, Ukraine, 21009
    • Oscotec Investigational Site (Site 2509)
  • Ivano-Frankivs'ka Oblast
    • Ivano-Frankivs'k, Ivano-Frankivs'ka Oblast, Ukraine, 76018
      • Oscotec Investigational Site (Site 2510)
  • Ternopil's'ka Oblast'
    • Ternopil', Ternopil's'ka Oblast', Ukraine, 46002
      • Oscotec Investigational Site (Site 2505)
  • Vinnyts'ka Oblast'
    • Vinnytsia, Vinnyts'ka Oblast', Ukraine, 21018
      • Oscotec Investigational Site (Site 2506)
    • Vinnytsia, Vinnyts'ka Oblast', Ukraine, 21029
      • Oscotec Investigational Site (Site 2504)
• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Oscotec Investigational Site (Site 3110)
    • Upland, California, United States, 91786
      • Oscotec Investigational Site (Site 3105)
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • Oscotec Investigational (Site 3104)
    • Tampa, Florida, United States, 33614
      • Oscotec Investigational Site (Site 3112)
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Oscotec Investigational Site (Site 3108)
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Oscotec Investigational Site (Site 3102)
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Oscotec Investigational Site (Site 3107)
  • Texas
    • Carrollton, Texas, United States, 75010
      • Oscotec Investigational Site (3106)
    • Houston, Texas, United States, 77034
      • Oscotec Investigational Site (Site 3111)
    • Mesquite, Texas, United States, 75150
      • Oscotec Investigational Site (Site 3109)
    • San Antonio, Texas, United States, 78229
      • Oscotec Investigational Site (Site 3103)
    • Tomball, Texas, United States, 77375
      • Oscotec Investigational Site (Site 3101)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Oral administration, twice per day
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	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)	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	Baseline and Weeks 2, 4 8 and 12
Incidence of Adverse Events (AEs)		Up to Week 16
Incidence of Serious Adverse Events (SAEs)		Up to Week 16

Collaborators and Investigators

• Sponsor: Oscotec Inc.

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2019
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): October 1, 2020

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (ACTUAL): August 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: OSCO-P2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No