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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Itacitinib Placebo; Drug: Itacitinib

• Registration Number: NCT01626573
• Lead Sponsor: Incyte Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-22
• Primary Completion: 2013-07
• Study Completion: 2013-10
• Disposition First Submitted: 2014-03-26
• Disposition First Submitted QC: 2014-03-26
• Disposition First Posted: 2014-04-22
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Itacitinib 400 mg placebo twice a day	Itacitinib Placebo	Itacitinib 400 mg placebo twice a day
Itacitinib 400 mg twice a day	Itacitinib	Itacitinib 400 mg twice a day
Itacitinib 100mg once a day	Itacitinib	Itacitinib 100mg once a day
Itacitinib 100 mg placebo once a day	Itacitinib Placebo	Itacitinib 100 mg placebo once a day
Itacitinib 200 mg placebo twice a day	Itacitinib Placebo	Itacitinib 200 mg placebo twice a day
Itacitinib 100 mg placebo twice a day	Itacitinib Placebo	This dose group will be studied twice during the study.
Itacitinib 300 mg placebo once a day	Itacitinib Placebo	Itacitinib 300 mg placebo once a day
Itacitinib 600 mg placebo once a day	Itacitinib Placebo	Itacitinib 600 mg placebo once a day
Itacitinib 100 mg twice a day	Itacitinib	This dose group will be studied twice during the study.
Itacitinib 200 mg twice a day	Itacitinib	Itacitinib 200 mg twice a day
Itacitinib 300 mg once a day	Itacitinib	Itacitinib 300 mg once a day
Itacitinib 600 mg once a day	Itacitinib	Itacitinib 600 mg once a day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).