Back to resultsINCB047986 in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
INCB047986
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
INCB047986 4 mg QD
INCB047986 8 mg QD
INCB047986 12 mg QD
INCB047986 placebo QD
Arm Description
INCB047986 4 mg will be orally self-administered once daily (QD) for 28 days.
INCB047986 8 mg will be orally self-administered once daily (QD) for 28 days.
INCB047986 12 mg will be orally self-administered once daily (QD) for 28 days.
INCB047986 placebo will be orally self-administered once daily (QD) for 28 days.
Outcomes
Primary Outcome Measures
Percentage of participants with adverse events, changes in electrocardiograms (ECGs), vital signs, physical examinations, or clinical laboratory evaluations
Percentage of Participants Achieving American College of Rheumatology, 20% Improvement (ACR20)
Secondary Outcome Measures
Percentage of subjects achieving ACR20 at each visit assessed.
Percentage of subjects achieving American College of Rheumatology, 50% improvement (ACR50) at each visit assessed.
Percentage of subjects achieving American College of Rheumatology, 70% improvement (ACR70) at each visit assessed.
Change in Disease Activity Score - 28-joint count (DAS28) C-reactive protein (CRP) at the Day 28 visit.
Change in DAS28 erythrocyte sedimentation rate (ESR) at the Day 28 visit.
Percentage of subjects achieving a DAS28 of ≤ 3.2 at the Day 28 visit.
Percentage of subjects achieving a DAS28 of ≤ 2.6 at the Day 28 visit.
Change in individual American College of Rheumatology (ACR) assessments.
Preliminary pharmacokinetic (PK)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02151474
Brief Title
INCB047986 in Rheumatoid Arthritis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Business decision.
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INCB047986 4 mg QD
Arm Type
Experimental
Arm Description
INCB047986 4 mg will be orally self-administered once daily (QD) for 28 days.
Arm Title
INCB047986 8 mg QD
Arm Type
Experimental
Arm Description
INCB047986 8 mg will be orally self-administered once daily (QD) for 28 days.
Arm Title
INCB047986 12 mg QD
Arm Type
Experimental
Arm Description
INCB047986 12 mg will be orally self-administered once daily (QD) for 28 days.
Arm Title
INCB047986 placebo QD
Arm Type
Experimental
Arm Description
INCB047986 placebo will be orally self-administered once daily (QD) for 28 days.
Intervention Type
Drug
Intervention Name(s)
INCB047986
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentage of participants with adverse events, changes in electrocardiograms (ECGs), vital signs, physical examinations, or clinical laboratory evaluations
Time Frame
Baseline through day 28
Title
Percentage of Participants Achieving American College of Rheumatology, 20% Improvement (ACR20)
Time Frame
Baseline through Day 28
Secondary Outcome Measure Information:
Title
Percentage of subjects achieving ACR20 at each visit assessed.
Time Frame
Baseline, Day 8, 15 and Follow-Up
Title
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
Title
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
Title
Change in Disease Activity Score - 28-joint count (DAS28) C-reactive protein (CRP) at the Day 28 visit.
Time Frame
Day 28
Title
Change in DAS28 erythrocyte sedimentation rate (ESR) at the Day 28 visit.
Time Frame
Day 28
Title
Percentage of subjects achieving a DAS28 of ≤ 3.2 at the Day 28 visit.
Time Frame
Day 28
Title
Percentage of subjects achieving a DAS28 of ≤ 2.6 at the Day 28 visit.
Time Frame
Day 28
Title
Change in individual American College of Rheumatology (ACR) assessments.
Time Frame
Day 28
Title
Preliminary pharmacokinetic (PK)
Time Frame
Evaluated after 15 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Levy, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
Orange
State/Province
California
Country
United States
City
Debary
State/Province
Florida
Country
United States
City
Palm Harbor
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Frederick
State/Province
Maryland
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
The Woodlands
State/Province
Texas
Country
United States
12. IPD Sharing Statement
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INCB047986 in Rheumatoid Arthritis
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