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

Sponsor

Incyte Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01626573

Collaborator

(none)

106

Enrollment

Locations

Arms

Duration (Months)

5.9

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Itacitinib Drug: Itacitinib Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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 Itacitinib in Subjects With Active Rheumatoid Arthritis

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Itacitinib 400 mg twice a day Itacitinib 400 mg twice a day	Drug: Itacitinib Other Names: INCB039110
Placebo Comparator: Itacitinib 400 mg placebo twice a day 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 Itacitinib 100mg once a day	Drug: Itacitinib Other Names: INCB039110
Placebo Comparator: Itacitinib 100 mg placebo once a day Itacitinib 100 mg placebo once a day	Drug: Itacitinib Placebo
Experimental: Itacitinib 200 mg twice a day Itacitinib 200 mg twice a day	Drug: Itacitinib Other Names: INCB039110
Placebo Comparator: Itacitinib 200 mg placebo twice a day Itacitinib 200 mg placebo twice a day	Drug: Itacitinib Placebo
Experimental: Itacitinib 300 mg once a day Itacitinib 300 mg once a day	Drug: Itacitinib Other Names: INCB039110
Placebo Comparator: Itacitinib 300 mg placebo once a day Itacitinib 300 mg placebo once a day	Drug: Itacitinib Placebo
Experimental: Itacitinib 600 mg once a day Itacitinib 600 mg once a day	Drug: Itacitinib Other Names: INCB039110
Placebo Comparator: Itacitinib 600 mg placebo once a day Itacitinib 600 mg placebo once a day	Drug: Itacitinib Placebo

Outcome Measures

Primary Outcome Measures

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. [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. [Approximately 84 days.]

Secondary Outcome Measures

Preliminary Pharmacokinetic (PK) collections. [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country
1	Palm Desert	California	United States
2	Pasadena	California	United States
3	Lake Mary	Florida	United States
4	Ocala	Florida	United States
5	Palm Harbor	Florida	United States
6	Tampa	Florida	United States
7	Tavares	Florida	United States
8	Lexington	Kentucky	United States
9	Worcester	Massachusetts	United States
10	Lansing	Michigan	United States
11	Raleigh	North Carolina	United States
12	Middleburg Heights	Ohio	United States
13	Duncansville	Pennsylvania	United States
14	Florence	South Carolina	United States
15	Austin	Texas	United States
16	Katy	Texas	United States
17	Spokane	Washington	United States
18	Carolina		Puerto Rico

Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director: Victor Sandor, MD, Incyte Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Incyte Corporation

ClinicalTrials.gov Identifier:

NCT01626573

Other Study ID Numbers:

39110-201

First Posted:

Jun 22, 2012

Last Update Posted:

Mar 12, 2019

Last Verified:

Mar 1, 2019

Keywords provided by Incyte Corporation

Rheumatoid Arthritis

Active

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Study Results

No Results Posted as of Mar 12, 2019