INCB047986 in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02151474
• Other study ID #: INCB 47986-202
• Status: Terminated
• Phase: Phase 2
• First received: May 28, 2014
• Last updated: February 3, 2015
• Start date: May 2014
• Est. completion date: August 2014

Study information

• Verified date: February 2015
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the safety, tolerability and efficacy of INCB047986, in subjects with moderate to severe rheumatoid arthritis.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• INCB047986

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with adverse events, changes in electrocardiograms (ECGs), vital signs, physical examinations, or clinical laboratory evaluations		Baseline through day 28	Yes
Primary	Percentage of Participants Achieving American College of Rheumatology, 20% Improvement (ACR20)		Baseline through Day 28	No
Secondary	Percentage of subjects achieving ACR20 at each visit assessed.		Baseline, Day 8, 15 and Follow-Up	No
Secondary	Percentage of subjects achieving American College of Rheumatology, 50% improvement (ACR50) at each visit assessed.		Baseline, Day 8, 15 28 and Follow-Up	No
Secondary	Percentage of subjects achieving American College of Rheumatology, 70% improvement (ACR70) at each visit assessed.		Baseline, Day 8, 15 28 and Follow-Up	No
Secondary	Change in Disease Activity Score - 28-joint count (DAS28) C-reactive protein (CRP) at the Day 28 visit.		Day 28	No
Secondary	Change in DAS28 erythrocyte sedimentation rate (ESR) at the Day 28 visit.		Day 28	No
Secondary	Percentage of subjects achieving a DAS28 of = 3.2 at the Day 28 visit.		Day 28	No
Secondary	Percentage of subjects achieving a DAS28 of = 2.6 at the Day 28 visit.		Day 28	No
Secondary	Change in individual American College of Rheumatology (ACR) assessments.		Day 28	No
Secondary	Preliminary pharmacokinetic (PK)		Evaluated after 15 days of treatment	No