Study Stopped
Business decision.
INCB047986 in Rheumatoid Arthritis
A Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of INCB047986 in Subjects With Active Rheumatoid Arthritis
1 other identifier
interventional
3
1 country
9
Brief Summary
The purpose of this study is to explore the safety, tolerability and efficacy of INCB047986, in subjects with moderate to severe rheumatoid arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 rheumatoid-arthritis
Started May 2014
Shorter than P25 for phase_2 rheumatoid-arthritis
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 28, 2014
CompletedFirst Posted
Study publicly available on registry
May 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFebruary 23, 2015
February 1, 2015
3 months
May 28, 2014
February 3, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of participants with adverse events, changes in electrocardiograms (ECGs), vital signs, physical examinations, or clinical laboratory evaluations
Baseline through day 28
Percentage of Participants Achieving American College of Rheumatology, 20% Improvement (ACR20)
Baseline through Day 28
Secondary Outcomes (9)
Percentage of subjects achieving ACR20 at each visit assessed.
Baseline, Day 8, 15 and Follow-Up
Percentage of subjects achieving American College of Rheumatology, 50% improvement (ACR50) at each visit assessed.
Baseline, Day 8, 15 28 and Follow-Up
Percentage of subjects achieving American College of Rheumatology, 70% improvement (ACR70) at each visit assessed.
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.
Day 28
Change in DAS28 erythrocyte sedimentation rate (ESR) at the Day 28 visit.
Day 28
- +4 more secondary outcomes
Study Arms (4)
INCB047986 4 mg QD
EXPERIMENTALINCB047986 4 mg will be orally self-administered once daily (QD) for 28 days.
INCB047986 8 mg QD
EXPERIMENTALINCB047986 8 mg will be orally self-administered once daily (QD) for 28 days.
INCB047986 12 mg QD
EXPERIMENTALINCB047986 12 mg will be orally self-administered once daily (QD) for 28 days.
INCB047986 placebo QD
EXPERIMENTALINCB047986 placebo will be orally self-administered once daily (QD) for 28 days.
Interventions
Eligibility Criteria
You may qualify if:
- Men or women aged 18 to 75 years, inclusive.
- Body mass index between 18 and 40 kg/m\^2, inclusive.
- Subjects must have a diagnosis of rheumatoid arthritis (RA) of at least 6 months' duration at the time of screening and must satisfy the ACR/European League Against Rheumatism (EULAR) 2010 Classification Criteria (Appendix B).
- Subjects must have active moderate to severe RA as determined by the following:
- ≥ 6 tender joints (28 joint count),
- ≥ 4 swollen joints (28 joint count), and
- CRP level ≥ 6 mg/L.
- Subjects must have a negative tuberculosis (TB) test (QuantiFERON®-TB Gold test or purified protein derivative (PPD)) at screening.
You may not qualify if:
- Current or recent history of severe and/or progressive uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease.
- Current or recent history (\< 30 days before screening and/or \< 45 days before randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial infection.
- Onset of RA before the age of 16 years.
- History of known or currently suspected inflammatory disease other than RA
- Current regimen of prednisone or equivalent with an average daily dose of \> 10 mg or having been treated with a stable daily dose ≤ 10 mg for \< 6 weeks.
- Previous treatment with at Janus kinase (JAK) inhibitor.
- Significant impairment of bone marrow function present at screening
- Receipt of any live vaccine within 2 months before screening or anticipated need for a live vaccine within the 2 months after last dose of study drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Orange, California, United States
Unknown Facility
DeBary, Florida, United States
Unknown Facility
Palm Harbor, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Frederick, Maryland, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
The Woodlands, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Richard Levy, MD
Incyte Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2014
First Posted
May 30, 2014
Study Start
May 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
February 23, 2015
Record last verified: 2015-02