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SKI-O-703 100 mg for Rheumatoid Arthritis

Phase 2
Waitlist Available
Research Sponsored by Oscotec Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 2, 4 8 and 12
Awards & highlights

Study 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.

Eligible Conditions
  • Rheumatoid Arthritis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 2, 4 8 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and weeks 2, 4 8 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in disease activity score
Secondary outcome measures
Health Assessment Questionnaire-Disability Index (HAQ-DI) score
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: SKI-O-703 400 mgExperimental Treatment1 Intervention
Group II: SKI-O-703 200 mgExperimental Treatment1 Intervention
Group III: SKI-O-703 100 mgExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SKI-O-703
2019
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Oscotec Inc.Lead Sponsor
7 Previous Clinical Trials
264 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
48 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~25 spots leftby Mar 2025