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A Study of Escalating Doses of Itacitinib Administered Orally in Patients With Plaque Psoriasis

NCT ID: NCT01634087

Last Updated: 2019-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-02-28

Brief Summary

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This is a study of itacitinib in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of itacitinib.

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Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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100 mg QD Itacitinib

Group Type EXPERIMENTAL

Itacitinib

Intervention Type DRUG

Itacitinib administered orally

100 mg QD Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo administered orally

200 mg QD Itacitinib

Group Type EXPERIMENTAL

Itacitinib

Intervention Type DRUG

Itacitinib administered orally

200 mg QD Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo administered orally

200 mg BID Itacitinib

Group Type EXPERIMENTAL

Itacitinib

Intervention Type DRUG

Itacitinib administered orally

200 mg BID Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo administered orally

600 mg once a day Itacitinib

Group Type EXPERIMENTAL

Itacitinib

Intervention Type DRUG

Itacitinib administered orally

600 mg once a day Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo administered orally

Interventions

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Itacitinib

Itacitinib administered orally

Intervention Type DRUG

Placebo

Placebo administered orally

Intervention Type DRUG

Other Intervention Names

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INCB039110

Eligibility Criteria

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Inclusion Criteria

* Subjects with chronic plaque psoriasis aged 18 to 75 who have had insufficient response to topical agents, and who meet the psoriasis assessment expectations as defined in the study protocol

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 leflunomide or other biological therapies to treat psoriasis and all JAK-STAT inhibitors within 12 weeks prior to first dose of study drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Incyte Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victor Sandor, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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Hot Springs, Arkansas, United States

Site Status

Los Angeles, California, United States

Site Status

Clinton, Minnesota, United States

Site Status

Fridley, Minnesota, United States

Site Status

Rochester, New York, United States

Site Status

Moncton, New Brunswick, Canada

Site Status

Windsor, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Québec, , Canada

Site Status

Countries

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United States Canada

Other Identifiers

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INCB 39110-250

Identifier Type: -

Identifier Source: org_study_id

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