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Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab (Humira®) in Chinese Subjects With Moderate to Severe Plaque Psoriasis

NCT01646073•AbbVie (prior sponsor, Abbott)

View on ClinicalTrials.gov

Summary

A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis.

Detailed Description

The purpose of this study is to evaluate the safety and efficacy of adalimumab and to determine how well it works in the treatment of adults with moderate to severe plaque psoriasis in the Chinese population. Psoriasis is a chronic immunologic disease characterized by marked inflammation and thickening of the epidermis that result in thick, scaly plaques involving the skin.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Clinical diagnosis of psoriasis for at least 6 months.
•Must have stable plaque psoriasis for at least 2 months before screening and baseline visits.
•Participant must have a Psoriasis Area Severity Index score greater than or equal to 10 at the baseline visit.
•Participant must have moderate to severe plaque Psoriasis, defined by Body Surface Area involvement greater than or equal to 10% at the baseline visit.
•Participant must have a Physicians Global Assessment of at least moderate disease at baseline visit.

Exclusion Criteria

•Diagnosis of other active skin diseases or skin infections.
•Participant has known hypersensitivity to adalimumab or it excipients.
•Participant has chronic recurring infections or active tuberculosis.
•Participant has demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
•Participant is known to have immune deficiency or is immunocompromised.

Locations (16)

Site Reference ID/Investigator# 72888

Beijing, China

Site Reference ID/Investigator# 72873

Beijing, China

Site Reference ID/Investigator# 72887

Beijing, China

Site Reference ID/Investigator# 85693

Chengdu, China

Site Reference ID/Investigator# 72976

Chongqing, China

Site Reference ID/Investigator# 72880

Dalian, China

Site Reference ID/Investigator# 72973

Guangzhou, China

Site Reference ID/Investigator# 72974

Guangzhou, China

Site Reference ID/Investigator# 72878

Hangzhou, Zhejiang, China

Site Reference ID/Investigator# 72877

Hangzhou, Zhejiang, China

Key Dates

Start Date

August 1, 2012

Primary Completion Date

December 1, 2013

Completion Date

December 1, 2013

Last Updated

January 19, 2015

Enrollment

425

ACTUAL participants

Conditions

Plaque Psoriasis

Interventions

Adalimumab

BIOLOGICAL

placebo

BIOLOGICAL

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

NCT07250802

Plaque Psoriasis

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RECRUITINGPHASE2

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

NCT07449702

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: January 19, 2015Data 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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Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

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

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis