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 - Tabular View

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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

This study is ongoing, but not recruiting participants.

Study NCT00570986. Last updated on October 31, 2008. Information provided by Abbott

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

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Brief Summary

Safety and efficacy of ABT-874 in the treatment of moderate to severe plaque psoriasis two doses of ABT-874 versus placebo

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

PGA [ Time Frame: Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12 ] [ Designated as safety issue: No ]
PASI [ Time Frame: Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12 ] [ Designated as safety issue: No ]
PGA [ Time Frame: Proportion of subjects maintaining a PGA 0/1 response at Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

DLQI [ Time Frame: Change from Baseline in DLQI total score vs. placebo at Week 12 ] [ Designated as safety issue: No ]
NAPSI [ Time Frame: % change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis ] [ Designated as safety issue: No ]
PASI [ Time Frame: Subjects who achieve PASI 90 and 100 at Week 12 ] [ Designated as safety issue: No ]
Safety parameters [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Condition ^†

Plaque Psoriasis

Intervention ^†

Drug: Placebo
Biological: ABT-874

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

1350

Start Date ^†

December 2007

Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Canada

Administrative Information Fields

NCT ID ^†

NCT00570986

Organization ID

M06-890

Secondary IDs ^††

Study Sponsor ^†

Abbott

Collaborators ^††

Investigators ^†

Study Director:

Joaquin Valdes, MD

Abbott

Information Provided By

Abbott

Verification Date

October 2008

First Received Date ^†

December 7, 2007

Last Updated Date

October 31, 2008

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