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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	Related Studies

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

This study has been completed.
Information provided by Abbott

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Subcutaneous Injections of ABT-874 vs Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Proportion of subjects with clinical response relative to Baseline PASI score [ Time Frame: Week 12, Week 40 and Week 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Quality of Life Surveys [ Time Frame: Week 12, Week 48 and Week 60 ] [ Designated as safety issue: Yes ]
Clinical response indicators [ Time Frame: Week 12, Week 48 and Week 60 ] [ Designated as safety issue: No ]
Safety parameters [ Time Frame: Monthly through duration of study ] [ Designated as safety issue: Yes ]

Condition ^†

Psoriasis

Intervention ^†

Drug: Anti IL-12 monoclonal antibody/ABT-874
Drug: placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

180

Start Date ^†

November 2005

Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00292396

Organization ID

M05-736

Secondary IDs ^††

Study Sponsor ^†

Abbott

Collaborators ^††

Investigators ^†

Study Director:

Beverly Paperiello

Abbott

Information Provided By

Abbott

Verification Date

June 2008

First Received Date ^†

February 14, 2006

Last Updated Date

June 26, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.