Clinical trial NCT02151474: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2014-05-30
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of participants with adverse events, changes in electrocardiograms (ECGs), vital signs, physical examinations, or clinical laboratory evaluations
timeFrame: Baseline through day 28
measure: Percentage of Participants Achieving American College of Rheumatology, 20% Improvement (ACR20)
timeFrame: Baseline through Day 28
Secondary outcomes:
measure: Percentage of subjects achieving ACR20 at each visit assessed.
timeFrame: Baseline, Day 8, 15 and Follow-Up
measure: Percentage of subjects achieving American College of Rheumatology, 50% improvement (ACR50) at each visit assessed.
timeFrame: Baseline, Day 8, 15 28 and Follow-Up
measure: Percentage of subjects achieving American College of Rheumatology, 70% improvement (ACR70) at each visit assessed.
timeFrame: Baseline, Day 8, 15 28 and Follow-Up
measure: Change in Disease Activity Score - 28-joint count (DAS28) C-reactive protein (CRP) at the Day 28 visit.
timeFrame: Day 28
measure: Change in DAS28 erythrocyte sedimentation rate (ESR) at the Day 28 visit.
timeFrame: Day 28
measure: Percentage of subjects achieving a DAS28 of ≤ 3.2 at the Day 28 visit.
timeFrame: Day 28
measure: Percentage of subjects achieving a DAS28 of ≤ 2.6 at the Day 28 visit.
timeFrame: Day 28
measure: Change in individual American College of Rheumatology (ACR) assessments.
timeFrame: Day 28
measure: Preliminary pharmacokinetic (PK)
timeFrame: Evaluated after 15 days of treatment
Other outcomes:
Locations:
city: Orange
country: United States
state: California
city: Debary
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Frederick
country: United States
state: Maryland
city: Charlotte
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Austin
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
Study officials:
affiliation: Incyte Corporation
name: Richard Levy, MD
role: STUDY_DIRECTOR
References: