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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: Placebo; Biological: ABT-874

Study type: Interventional

Funder types: Industry

Identifiers

NCT00570986

M06-890

Details and patient eligibility

About

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.

Enrollment: 1,465 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,465 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

2

Active Comparator group

Description:

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

Treatment:

Biological: ABT-874

Biological: ABT-874

3

Active Comparator group

Description:

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

Treatment:

Biological: ABT-874

Biological: ABT-874