NCT04057118

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Oscotec Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	SKI-O-703	Oral administration, twice per day
DRUG	Placebo	Oral administration, twice per day

Timeline

• Start date: 2019-03-20
• Primary completion: 2020-10-13
• Completion: 2020-10-13
• First posted: 2019-08-15
• Last updated: 2024-07-31
• Results posted: 2024-07-31

Locations

40 sites across 5 countries: United States, Czechia, Poland, Russia, Ukraine

Regulatory

• FDA-regulated drug study