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

March 8, 2019 updated by: Incyte Corporation

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 Itacitinib in Subjects With Active Rheumatoid Arthritis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Carolina, Puerto Rico
  • United States
    • California
      • Palm Desert, California, United States
      • Pasadena, California, 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
    • Kentucky
      • Lexington, Kentucky, United States
    • Massachusetts
      • Worcester, Massachusetts, United States
    • Michigan
      • Lansing, Michigan, United States
    • North Carolina
      • Raleigh, North Carolina, United States
    • Ohio
      • Middleburg Heights, Ohio, United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
    • South Carolina
      • Florence, South Carolina, United States
    • Texas
      • Austin, Texas, United States
      • Katy, Texas, United States
    • Washington
      • Spokane, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Itacitinib 400 mg twice a day
Drug: Itacitinib
Other Names:
  • INCB039110
Placebo Comparator: Itacitinib 400 mg placebo twice a day
Drug: Itacitinib Placebo
Experimental: Itacitinib 100 mg twice a day
This dose group will be studied twice during the study.
Drug: Itacitinib
Other Names:
  • INCB039110
Placebo Comparator: Itacitinib 100 mg placebo twice a day
This dose group will be studied twice during the study.
Drug: Itacitinib Placebo
Experimental: Itacitinib 100mg once a day
Drug: Itacitinib
Other Names:
  • INCB039110
Placebo Comparator: Itacitinib 100 mg placebo once a day
Drug: Itacitinib Placebo
Experimental: Itacitinib 200 mg twice a day
Drug: Itacitinib
Other Names:
  • INCB039110
Placebo Comparator: Itacitinib 200 mg placebo twice a day
Drug: Itacitinib Placebo
Experimental: Itacitinib 300 mg once a day
Drug: Itacitinib
Other Names:
  • INCB039110
Placebo Comparator: Itacitinib 300 mg placebo once a day
Drug: Itacitinib Placebo
Experimental: Itacitinib 600 mg once a day
Drug: Itacitinib
Other Names:
  • INCB039110
Placebo Comparator: Itacitinib 600 mg placebo once a day
Drug: Itacitinib Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of itacitinib 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.
Approximately four months.
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.
Approximately 84 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary Pharmacokinetic (PK) collections.
Time Frame: Following 15 days of therapy.
Plasma concentrations of itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).
Following 15 days of therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Victor Sandor, MD, Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (Estimate)

June 22, 2012

Study Record Updates

Last Update Posted (Actual)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39110-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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