At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 163 enrolled
Drug / intervention
SKI-O-703 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating SKI-O-703 and Placebo for Rheumatoid Arthritis. Completed, enrolled 163 participants across 40 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesCzechia, Poland, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartMar 2019
First PostedAug 2019
Primary CompletionOct 2020
TodayJul 2026
First PostedAug 15, 2019
Enrollment StartMar 20, 2019
Primary CompletionOct 13, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.9 years ago
Interventions
SKI-O-703drug
Oral administration, twice per day
Placebodrug
Oral administration, twice per day