A Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT ID: NCT00570986

Last Updated: 2013-02-08

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

PHASE3

Total Enrollment

1465 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-06-30

Brief Summary

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The purpose of this study is to determine the safety and efficacy of 2 doses of ABT-874 versus placebo in the treatment of subjects with moderate to severe plaque psoriasis.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Arm #1 is used for entire study. At week 12, arm is rerandomized.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.

2

Arm #2 is used for entire study. At week 12, arm is rerandomized.

Group Type ACTIVE_COMPARATOR

ABT-874

Intervention Type BIOLOGICAL

200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.

3

Arm #3 is not used for weeks 0-11. At week 12, arm is rerandomized.

Group Type ACTIVE_COMPARATOR

ABT-874

Intervention Type BIOLOGICAL

100mg every 12 weeks.

Interventions

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Placebo

Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.

Intervention Type DRUG

ABT-874

200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.

Intervention Type BIOLOGICAL

ABT-874

100mg every 12 weeks.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subject is \>= 18 years of age
* Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
* Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria

* Subject has previous exposure to systemic anti-IL 12 therapy
* Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
* Subject is taking or requires oral or injectible corticosteroids
* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
* Subject considered by the investigator, for any reason, to be an unsuitable candidate
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Kaul, MD

Role: STUDY_CHAIR

AbbVie

Locations

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Site Reference ID/Investigator# 6579

Birmingham, Alabama, United States

Site Status

Site Reference ID/Investigator# 6697

Birmingham, Alabama, United States

Site Status

Site Reference ID/Investigator# 7015

Huntsville, Alabama, United States

Site Status

Site Reference ID/Investigator# 6728

Scottsdale, Arizona, United States

Site Status

Site Reference ID/Investigator# 6584

Tucson, Arizona, United States

Site Status

Site Reference ID/Investigator# 6696

Little Rock, Arkansas, United States

Site Status

Site Reference ID/Investigator# 6591

Bakersfield, California, United States

Site Status

Site Reference ID/Investigator# 6710

Fresno, California, United States

Site Status

Site Reference ID/Investigator# 7885

Irvine, California, United States

Site Status

Site Reference ID/Investigator# 6872

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 7669

Oceanside, California, United States

Site Status

Site Reference ID/Investigator# 6821

San Diego, California, United States

Site Status

Site Reference ID/Investigator# 6832

San Diego, California, United States

Site Status

Site Reference ID/Investigator# 7305

San Diego, California, United States

Site Status

Site Reference ID/Investigator# 7990

San Francisco, California, United States

Site Status

Site Reference ID/Investigator# 6711

Santa Monica, California, United States

Site Status

Site Reference ID/Investigator# 8139

Torrance, California, United States

Site Status

Site Reference ID/Investigator# 7167

Vallejo, California, United States

Site Status

Site Reference ID/Investigator# 7302

Denver, Colorado, United States

Site Status

Site Reference ID/Investigator# 6921

Longmont, Colorado, United States

Site Status

Site Reference ID/Investigator# 6917

New Haven, Connecticut, United States

Site Status

Site Reference ID/Investigator# 6707

Jacksonville, Florida, United States

Site Status

Site Reference ID/Investigator# 7301

Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 7012

Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 6831

Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 7016

South Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 6590

West Palm Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 6582

Alpharetta, Georgia, United States

Site Status

Site Reference ID/Investigator# 7450

Atlanta, Georgia, United States

Site Status

Site Reference ID/Investigator# 6714

Newnan, Georgia, United States

Site Status

Site Reference ID/Investigator# 6717

Snellville, Georgia, United States

Site Status

Site Reference ID/Investigator# 7017

Arlington Heights, Illinois, United States

Site Status

Site Reference ID/Investigator# 7877

Maywood, Illinois, United States

Site Status

Site Reference ID/Investigator# 6704

Skokie, Illinois, United States

Site Status

Site Reference ID/Investigator# 7292

West Dundee, Illinois, United States

Site Status

Site Reference ID/Investigator# 6706

Indianapolis, Indiana, United States

Site Status

Site Reference ID/Investigator# 7646

Indianapolis, Indiana, United States

Site Status

Site Reference ID/Investigator# 7014

Overland Park, Kansas, United States

Site Status

Site Reference ID/Investigator# 6873

Louisville, Kentucky, United States

Site Status

Site Reference ID/Investigator# 7523

Owensboro, Kentucky, United States

Site Status

Site Reference ID/Investigator# 6597

Andover, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 6703

Boston, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 7644

Detroit, Michigan, United States

Site Status

Site Reference ID/Investigator# 6826

Fort Gratiot, Michigan, United States

Site Status

Site Reference ID/Investigator# 7989

Grand Blanc, Michigan, United States

Site Status

Site Reference ID/Investigator# 6581

Fridley, Minnesota, United States

Site Status

Site Reference ID/Investigator# 7890

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 6709

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 7451

Omaha, Nebraska, United States

Site Status

Site Reference ID/Investigator# 7299

Berlin, New Jersey, United States

Site Status

Site Reference ID/Investigator# 6924

East Windsor, New Jersey, United States

Site Status

Site Reference ID/Investigator# 6577

New Brunswick, New Jersey, United States

Site Status

Site Reference ID/Investigator# 7030

Albuquerque, New Mexico, United States

Site Status

Site Reference ID/Investigator# 7878

Buffalo, New York, United States

Site Status

Site Reference ID/Investigator# 7876

New York, New York, United States

Site Status

Site Reference ID/Investigator# 6599

New York, New York, United States

Site Status

Site Reference ID/Investigator# 6895

New York, New York, United States

Site Status

Site Reference ID/Investigator# 7637

New York, New York, United States

Site Status

Site Reference ID/Investigator# 7504

Rochester, New York, United States

Site Status

Site Reference ID/Investigator# 7018

Stoney Brook, New York, United States

Site Status

Site Reference ID/Investigator# 6926

Hickory, North Carolina, United States

Site Status

Site Reference ID/Investigator# 7293

Wilmington, North Carolina, United States

Site Status

Site Reference ID/Investigator# 8251

Winston-Salem, North Carolina, United States

Site Status

Site Reference ID/Investigator# 6598

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 8082

Cleveland, Ohio, United States

Site Status

Site Reference ID/Investigator# 7165

Columbus, Ohio, United States

Site Status

Site Reference ID/Investigator# 7659

Dayton, Ohio, United States

Site Status

Site Reference ID/Investigator# 6727

Lake Oswego, Oregon, United States

Site Status

Site Reference ID/Investigator# 6894

Portland, Oregon, United States

Site Status

Site Reference ID/Investigator# 6578

Portland, Oregon, United States

Site Status

Site Reference ID/Investigator# 7295

Portland, Oregon, United States

Site Status

Site Reference ID/Investigator# 7879

Hershey, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 6712

Philadelphia, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 6580

Johnston, Rhode Island, United States

Site Status

Site Reference ID/Investigator# 6576

Providence, Rhode Island, United States

Site Status

Site Reference ID/Investigator# 6589

Greer, South Carolina, United States

Site Status

Site Reference ID/Investigator# 6586

Goodlettsville, Tennessee, United States

Site Status

Site Reference ID/Investigator# 7668

Knoxville, Tennessee, United States

Site Status

Site Reference ID/Investigator# 6915

Nashville, Tennessee, United States

Site Status

Site Reference ID/Investigator# 6825

Arlington, Texas, United States

Site Status

Site Reference ID/Investigator# 6762

Austin, Texas, United States

Site Status

Site Reference ID/Investigator# 6822

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 7671

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 6705

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 6708

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 7081

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 6912

Tyler, Texas, United States

Site Status

Site Reference ID/Investigator# 7306

Webster, Texas, United States

Site Status

Site Reference ID/Investigator# 8101

Salt Lake City, Utah, United States

Site Status

Site Reference ID/Investigator# 6807

Norfolk, Virginia, United States

Site Status

Site Reference ID/Investigator# 6801

Seattle, Washington, United States

Site Status

Site Reference ID/Investigator# 7519

Spokane, Washington, United States

Site Status

Site Reference ID/Investigator# 7080

Milwaukee, Wisconsin, United States

Site Status

Site Reference ID/Investigator# 7314

Barrie, , Canada

Site Status

Site Reference ID/Investigator# 7452

Calgary, , Canada

Site Status

Site Reference ID/Investigator# 6702

Edmonton, , Canada

Site Status

Site Reference ID/Investigator# 6716

Halifax, , Canada

Site Status

Site Reference ID/Investigator# 7309

Hamilton, , Canada

Site Status

Site Reference ID/Investigator# 6588

Laval, , Canada

Site Status

Site Reference ID/Investigator# 6715

London, , Canada

Site Status

Site Reference ID/Investigator# 7315

London, , Canada

Site Status

Site Reference ID/Investigator# 7636

Markham, , Canada

Site Status

Site Reference ID/Investigator# 6699

Montreal, , Canada

Site Status

Site Reference ID/Investigator# 7316

Montreal, , Canada

Site Status

Site Reference ID/Investigator# 7088

North Bay, , Canada

Site Status

Site Reference ID/Investigator# 7310

Ottawa, , Canada

Site Status

Site Reference ID/Investigator# 7311

Québec, , Canada

Site Status

Site Reference ID/Investigator# 7313

St. John's, , Canada

Site Status

Site Reference ID/Investigator# 7317

Surrey, , Canada

Site Status

Site Reference ID/Investigator# 7308

Vancouver, , Canada

Site Status

Site Reference ID/Investigator# 6713

Vancouver, , Canada

Site Status

Site Reference ID/Investigator# 7067

Waterloo, , Canada

Site Status

Site Reference ID/Investigator# 7312

Westmount, , Canada

Site Status

Site Reference ID/Investigator# 7087

Windsor, , Canada

Site Status

Site Reference ID/Investigator# 6805

Windsor, , Canada

Site Status

Site Reference ID/Investigator# 7638

Winnipeg, , Canada

Site Status

Countries

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United States Canada

Other Identifiers

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M06-890

Identifier Type: -

Identifier Source: org_study_id

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