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 - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00570986

Purpose

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

Condition	Intervention	Phase
Plaque Psoriasis	Drug: Placebo Biological: ABT-874	Phase III

MedlinePlus related topics: Psoriasis

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

Further study details as provided by Abbott:

Primary Outcome Measures:

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 Measures:

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 ]

Estimated Enrollment:	1350
Study Start Date:	December 2007
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Arm #1 is used for entire study. At week 12, arm is rerandomized.	Drug: Placebo Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.
2: Active Comparator Arm #2 is used for entire study. At week 12, arm is rerandomized.	Biological: ABT-874 200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.
3: Active Comparator Arm #3 is not used for weeks 0-11. At week 12, arm is rerandomized.	Biological: ABT-874 100mg every 12 weeks.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570986

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Joaquin Valdes, MD

Abbott

More Information

Responsible Party:	Abbott ( Beverly Paperiello, Director, Immunology Development )
Study ID Numbers:	M06-890
Study First Received:	December 7, 2007
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00570986
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Plaque Psoriasis

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on January 13, 2009