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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04057118
• Date of registration: 13/08/2019
• Prospective Registration: No
• Primary sponsor: Oscotec Inc.
• Public title: A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.
• Scientific 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
• Date of first enrolment: March 20, 2019
• Target sample size: 148
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT04057118
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Czechia, Poland, Russian Federation, Ukraine, United States

Key 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: SKI-O-703

Drug: Placebo

Primary Outcome(s)

Change in disease activity score [Time Frame: Baseline and Week 12]

Secondary Outcome(s)

• Percentage of patients with ACR20 (American College of Rheumatology 20) score [Time Frame: Baseline and Weeks 2, 4 8 and 12]

Health Assessment Questionnaire-Disability Index (HAQ-DI) score [Time Frame: Baseline and Weeks 2, 4 8 and 12]

Incidence of Serious Adverse Events (SAEs) [Time Frame: Up to Week 16]

• Percentage of patients with ACR70 (American College of Rheumatology 70) score [Time Frame: Baseline and Weeks 2, 4 8 and 12]

• Percentage of patients with ACR50 (American College of Rheumatology 50) score [Time Frame: Baseline and Weeks 2, 4 8 and 12]

Incidence of Adverse Events (AEs) [Time Frame: Up to Week 16]

Secondary ID(s)

OSCO-P2201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors