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Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT ID: NCT00292396

Last Updated: 2013-01-18

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

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-04-30

Brief Summary

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The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis.

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Detailed Description

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Conditions

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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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1

Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks

Group Type ACTIVE_COMPARATOR

Anti IL-12 monoclonal antibody/ABT-874

Intervention Type DRUG

Please see Arm Description for intervention description and details.

2

Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks

Group Type ACTIVE_COMPARATOR

Anti IL-12 monoclonal antibody/ABT-874

Intervention Type DRUG

Please see Arm Description for intervention description and details.

3

Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks

Group Type ACTIVE_COMPARATOR

Anti IL-12 monoclonal antibody/ABT-874

Intervention Type DRUG

Please see Arm Description for intervention description and details.

4

Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks

Group Type ACTIVE_COMPARATOR

Anti IL-12 monoclonal antibody/ABT-874

Intervention Type DRUG

Please see Arm Description for intervention description and details.

5

Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks

Group Type ACTIVE_COMPARATOR

Anti IL-12 monoclonal antibody/ABT-874

Intervention Type DRUG

Please see Arm Description for intervention description and details.

6

placebo, 12 doses

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

12 doses

Interventions

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Anti IL-12 monoclonal antibody/ABT-874

Please see Arm Description for intervention description and details.

Intervention Type DRUG

placebo

12 doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
* Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis

Exclusion Criteria

* Subject had previously received systemic or biologic 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 injectable corticosteroids
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* 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# 3351

San Diego, California, United States

Site Status

Site Reference ID/Investigator# 3347

Alpharetta, Georgia, United States

Site Status

Site Reference ID/Investigator# 3348

Skokie, Illinois, United States

Site Status

Site Reference ID/Investigator# 993

Indianapolis, Indiana, United States

Site Status

Site Reference ID/Investigator# 990

Boston, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 3349

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 992

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 991

Lake Oswego, Oregon, United States

Site Status

Site Reference ID/Investigator# 3367

Portland, Oregon, United States

Site Status

Site Reference ID/Investigator# 3346

Johnston, Rhode Island, United States

Site Status

Site Reference ID/Investigator# 994

Nashville, Tennessee, United States

Site Status

Site Reference ID/Investigator# 3350

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 796

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 2081

Salt Lake City, Utah, United States

Site Status

Site Reference ID/Investigator# 3366

Norfolk, Virginia, United States

Site Status

Site Reference ID/Investigator# 989

Seattle, Washington, United States

Site Status

Site Reference ID/Investigator# 3361

Halifax, , Canada

Site Status

Site Reference ID/Investigator# 985

Laval, , Canada

Site Status

Site Reference ID/Investigator# 987

London, , Canada

Site Status

Site Reference ID/Investigator# 3364

Montreal, , Canada

Site Status

Site Reference ID/Investigator# 794

North Bay, , Canada

Site Status

Site Reference ID/Investigator# 988

Québec, , Canada

Site Status

Site Reference ID/Investigator# 795

Waterloo, , Canada

Site Status

Site Reference ID/Investigator# 3360

Windsor, , Canada

Site Status

Countries

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United States Canada

References

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Kimball AB, Gordon KB, Langley RG, Menter A, Chartash EK, Valdes J; ABT-874 Psoriasis Study Investigators. Safety and efficacy of ABT-874, a fully human interleukin 12/23 monoclonal antibody, in the treatment of moderate to severe chronic plaque psoriasis: results of a randomized, placebo-controlled, phase 2 trial. Arch Dermatol. 2008 Feb;144(2):200-7. doi: 10.1001/archdermatol.2007.63.

Reference Type DERIVED
PMID: 18283176 (View on PubMed)

Other Identifiers

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M05-736

Identifier Type: -

Identifier Source: org_study_id

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