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

COMPLETEDPHASE3

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

A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis

NCT01970488•Amgen

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

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

Locations (3)

Research Site

Saint Leonards, New South Wales, Australia

Research Site

St. John's, Newfoundland and Labrador, Canada

Research Site

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

Key Dates

Start Date

October 18, 2013

Primary Completion Date

August 14, 2014

Completion Date

March 18, 2015

Last Updated

April 3, 2019

Enrollment

350

ACTUAL participants

Conditions

Psoriasis

Interventions

Adalimumab

BIOLOGICAL

ABP 501

BIOLOGICAL

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Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments