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

Amgen

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Biological: Adalimumab; Biological: ABP 501

Study type: Interventional

Funder types: Industry

Identifiers

NCT01970488

2013-000537-12 (EudraCT Number)

20120263

Details and patient eligibility

About

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

Enrollment: 350 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Other Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 2 patient groups

ABP 501

Experimental group

Description:

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.

Treatment:

Biological: ABP 501

Adalimumab

Active Comparator group

Description:

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.

Treatment:

Biological: Adalimumab