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

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 2, 4 8 and 12

Summary

This trial is testing SKI-O-703, a new medication, in patients with rheumatoid arthritis who haven't responded to other treatments. The goal is to see if it can reduce joint pain and swelling.

Eligible Conditions
  • Rheumatoid Arthritis

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Disease Activity Score
Secondary study objectives
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
• Percentage of Patients With ACR20 (American College of Rheumatology 20) Score
• Percentage of Patients With ACR50 (American College of Rheumatology 50) Score
+1 more

Side effects data

From 2023 Phase 2 trial • 61 Patients • NCT04056195
15%
Petechiae
12%
Corona virus infection
8%
Alanine aminotransferase increased
8%
Aspartate aminotransferase increased
4%
Anaemia
4%
Epistaxis
4%
Nausea
4%
Haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
SKI-O-703 200 mg BID
SKI-O-703 400 mg BID
Placebo

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
~230

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
~24 spots leftby Dec 2025
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