Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-18

Study Completion Date

2015-03-18

Brief Summary

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The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with 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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ABP 501

Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16.

Participants with a PASI 50 response at week 16 continued to receive 40 mg APB 501 until week 48.

Group Type EXPERIMENTAL

ABP 501

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Adalimumab

Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16.

At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to ABP 501 until week 48.

Group Type ACTIVE_COMPARATOR

Adalimumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Interventions

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Adalimumab

Administered by subcutaneous injection

Intervention Type BIOLOGICAL

ABP 501

Administered by subcutaneous injection

Intervention Type BIOLOGICAL

Other Intervention Names

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HUMIRA® Adalimumab-atto AMJEVITA™

Eligibility Criteria

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Inclusion Criteria

1. Men or women ≥ 18 and ≤ 75 years of age at time of screening
2. Stable moderate to severe plaque psoriasis for at least 6 months before baseline
3. Moderate to severe psoriasis defined at screening and baseline by:

Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score of 12 or greater, and static physician's global assessment score of 3 or greater
4. No known history of active tuberculosis
5. Subject is a candidate for systemic therapy or phototherapy procedures
6. Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy

Exclusion Criteria

1. Forms of psoriasis or other skin conditions at the time of the screening visit (eg, eczema)
2. Ongoing use of prohibited treatments
3. Prior use of 2 or more biologics for treatment of psoriasis
4. Previous receipt of adalimumab or a biosimilar of adalimumab

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No