The purpose of this study is to explore the safety, tolerability and efficacy of INCB047986, in subjects with moderate to severe rheumatoid arthritis.
This will be a double-blind, placebo-controlled study with 4 parallel treatment groups. Subjects will be screened for up to 28 days before study drug administration to ensure that all eligibility criteria are met. On Day 1, subjects will be randomized to 1 of 4 dose groups of 15 subjects each (INCB047986 4 mg, 8 mg, 12 mg, or placebo QD). Study drug will be self administered on Days 1 through 28. A follow-up telephone call to the subject to assess safety will occur at Day 42. A final safety and efficacy evaluation will be performed at the Day 58 visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3
Unnamed facility
Orange, California, United States
Unnamed facility
DeBary, Florida, United States
Unnamed facility
Palm Harbor, Florida, United States
Unnamed facility
Tampa, Florida, United States
Percentage of participants with adverse events, changes in electrocardiograms (ECGs), vital signs, physical examinations, or clinical laboratory evaluations
Time frame: Baseline through day 28
Percentage of Participants Achieving American College of Rheumatology, 20% Improvement (ACR20)
Time frame: Baseline through Day 28
Percentage of subjects achieving ACR20 at each visit assessed.
Time frame: Baseline, Day 8, 15 and Follow-Up
Percentage of subjects achieving American College of Rheumatology, 50% improvement (ACR50) at each visit assessed.
Time frame: Baseline, Day 8, 15 28 and Follow-Up
Percentage of subjects achieving American College of Rheumatology, 70% improvement (ACR70) at each visit assessed.
Time frame: Baseline, Day 8, 15 28 and Follow-Up
Change in Disease Activity Score - 28-joint count (DAS28) C-reactive protein (CRP) at the Day 28 visit.
Time frame: Day 28
Change in DAS28 erythrocyte sedimentation rate (ESR) at the Day 28 visit.
Time frame: Day 28
Percentage of subjects achieving a DAS28 of ≤ 3.2 at the Day 28 visit.
Time frame: Day 28
Percentage of subjects achieving a DAS28 of ≤ 2.6 at the Day 28 visit.
Time frame: Day 28
Change in individual American College of Rheumatology (ACR) assessments.
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Unnamed facility
Frederick, Maryland, United States
Unnamed facility
Charlotte, North Carolina, United States
Unnamed facility
Oklahoma City, Oklahoma, United States
Unnamed facility
Austin, Texas, United States
Unnamed facility
The Woodlands, Texas, United States
Time frame: Day 28
Preliminary pharmacokinetic (PK)
Time frame: Evaluated after 15 days of treatment