A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of INCB039110 in Subjects With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01626573
First received: May 3, 2012
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

This is a study evaluating a 28-day course followed by a 56-day course of INCB039110 in patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy parameters of INCB039110.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: INCB039110
Drug: INCB039110 Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double- Blind, Placebo Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of INCB039110 in Subjects With Active Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Safety and tolerability of INCB039110 as assessed by the changes in frequency and severity of adverse events, ECGs, vital signs, physical examinations, and clinical laboratory evaluations. [ Time Frame: Approximately four months. ] [ Designated as safety issue: Yes ]
  • Preliminary efficacy as assessed by the percentage of patients achieving ACR20 improvement from baseline on the day 28 and day 84 visits. [ Time Frame: Approximately 84 days. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Preliminary Pharmacokinetic (PK) collections. [ Time Frame: Following 15 days of therapy. ] [ Designated as safety issue: No ]
    Plasma concentrations of INCB039110 will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).


Enrollment: 106
Study Start Date: March 2012
Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INCB039110 400 mg twice a day
INCB039110 400 mg twice a day
Drug: INCB039110
Placebo Comparator: INCB039110 400 mg placebo twice a day
INCB039110 400 mg placebo twice a day
Drug: INCB039110 Placebo
Experimental: INCB039110 100 mg twice a day
This dose group will be studied twice during the study.
Drug: INCB039110
Placebo Comparator: INCB039110 100 mg placebo twice a day
This dose group will be studied twice during the study.
Drug: INCB039110 Placebo
Experimental: INCB039110 100mg once a day
INCB039110 100mg once a day
Drug: INCB039110
Placebo Comparator: INCB039110 100 mg placebo once a day
INCB039110 100 mg placebo once a day
Drug: INCB039110 Placebo
Experimental: INCB039110 200 mg twice a day
INCB039110 200 mg twice a day
Drug: INCB039110
Placebo Comparator: INCB039110 200 mg placebo twice a day
INCB039110 200 mg placebo twice a day
Drug: INCB039110 Placebo
Experimental: INCB039110 300 mg once a day
INCB039110 300 mg once a day
Drug: INCB039110
Placebo Comparator: INCB039110 300 mg placebo once a day
INCB039110 300 mg placebo once a day
Drug: INCB039110 Placebo
Experimental: INCB039110 600 mg once a day
INCB039110 600 mg once a day
Drug: INCB039110
Placebo Comparator: INCB039110 600 mg placebo once a day
INCB039110 600 mg placebo once a day
Drug: INCB039110 Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with active RA aged 18 to 75 years of age and meet tender and swollen joint assessment expectations defined in the study protocol.
  • c-Reactive protein (CRP) or erythrocyte sedimentation rate (ESR) laboratory values meet minimal study protocol expectations.

Exclusion Criteria:

  • Females who are pregnant or breastfeeding.
  • Men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively.
  • Subjects treated with a biologic agent within 12 weeks prior to first dose of study drug. (12 months in the case of rituximab.)
  • Subjects with a history or currently suspected inflammatory disease other than RA.
  • Subjects with a history of hematological disorders.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626573

Locations
United States, California
Palm Desert, California, United States
Pasadena, California, United States
United States, Florida
Lake Mary, Florida, United States
Ocala, Florida, United States
Palm Harbor, Florida, United States
Tampa, Florida, United States
Tavares, Florida, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Massachusetts
Worchester, Massachusetts, United States
United States, Michigan
Lansing, Michigan, United States
United States, North Carolina
Raleigh, North Carolina, United States
United States, Ohio
Middleburg Heights, Ohio, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
United States, South Carolina
Florence, South Carolina, United States
United States, Texas
Austin, Texas, United States
Katy, Texas, United States
United States, Washington
Spokane, Washington, United States
Puerto Rico
Carolina, Puerto Rico
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Victor Sandor, MD Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01626573     History of Changes
Other Study ID Numbers: 39110-201
Study First Received: May 3, 2012
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
Rheumatoid Arthritis
RA
Active

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 27, 2014