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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Itacitinib
* Drug: Itacitinib Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Itacitinib 400 mg twice a day<br>Itacitinib 400 mg twice a day | Drug: Itacitinib<br> <br> * Other names: INCB039110;|
| Placebo Comparator: Itacitinib 400 mg placebo twice a day<br>Itacitinib 400 mg placebo twice a day | Drug: Itacitinib Placebo<br> <br> |
| Experimental: Itacitinib 100 mg twice a day<br>This dose group will be studied twice during the study. | Drug: Itacitinib<br> <br> * Other names: INCB039110;|
| Placebo Comparator: Itacitinib 100 mg placebo twice a day<br>This dose group will be studied twice during the study. | Drug: Itacitinib Placebo<br> <br> |
| Experimental: Itacitinib 100mg once a day<br>Itacitinib 100mg once a day | Drug: Itacitinib<br> <br> * Other names: INCB039110;|
| Placebo Comparator: Itacitinib 100 mg placebo once a day<br>Itacitinib 100 mg placebo once a day | Drug: Itacitinib Placebo<br> <br> |
| Experimental: Itacitinib 200 mg twice a day<br>Itacitinib 200 mg twice a day | Drug: Itacitinib<br> <br> * Other names: INCB039110;|
| Placebo Comparator: Itacitinib 200 mg placebo twice a day<br>Itacitinib 200 mg placebo twice a day | Drug: Itacitinib Placebo<br> <br> |
| Experimental: Itacitinib 300 mg once a day<br>Itacitinib 300 mg once a day | Drug: Itacitinib<br> <br> * Other names: INCB039110;|
| Placebo Comparator: Itacitinib 300 mg placebo once a day<br>Itacitinib 300 mg placebo once a day | Drug: Itacitinib Placebo<br> <br> |
| Experimental: Itacitinib 600 mg once a day<br>Itacitinib 600 mg once a day | Drug: Itacitinib<br> <br> * Other names: INCB039110;|
| Placebo Comparator: Itacitinib 600 mg placebo once a day<br>Itacitinib 600 mg placebo once a day | Drug: Itacitinib Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary Pharmacokinetic (PK) collections. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RA, Rheumatoid Arthritis, Active