Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 163
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: SKI-O-703 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral administration, twice per day intervention 2: Oral administration, twice per day

Protocol document:
Prot_002.pdf: 




Oscotec Inc 
Protocol: OSCO-P220 I Version 5.0 Amendment 4 
Protocol Approval - Sponsor Signatory 
SKl-O-703 
19 Oct 2020 
Study 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 
Protocol Number 
OSCO-P2201 
Protocol Date 
19 Oct 2020 
Protocol accepted and approved by: 
Page 3268


Oscotec Inc 
Protocol: OSCO-P2201 Version 5.0 Amendment 4 
Protocol Approval - Principal/Coordinating Investigator 
SKl-O-703 
19 Oct 2020 
Study 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 
Protocol N um her
OSCO-P2201 
Protocol Date 
19 Oct 2020 
Protocol accepted and approved by: 
Page 3269



























































































































































































































SAP_001.pdf: