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

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Plaque Psoriasis

Intervention: Adalimumab (Biological); placebo (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Martin Okun, MD, Study Chair, Affiliation: AbbVie

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12

Secondary outcome:

Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A]

Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B]

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A]

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B]

Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A]

Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B]

Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period A]

Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period B]

Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period A]

Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period B]

Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period A]

Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period B]

Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period A]

Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period B]

Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A]

Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B]

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Site Reference ID/Investigator# 72873, Beijing 100044, China

Site Reference ID/Investigator# 72887, Beijing 100730, China

Site Reference ID/Investigator# 72888, Beijing 100034, China

Site Reference ID/Investigator# 85693, Chengdu 610072, China

Site Reference ID/Investigator# 72976, Chongqing 400038, China

Site Reference ID/Investigator# 72880, Dalian 116011, China

Site Reference ID/Investigator# 72973, Guangzhou 510120, China

Site Reference ID/Investigator# 72974, Guangzhou 510630, China

Site Reference ID/Investigator# 72877, Hangzhou, Zhejiang 310009, China

Site Reference ID/Investigator# 72878, Hangzhou, Zhejiang 310003, China

Site Reference ID/Investigator# 87058, Jinan 250012, China

Site Reference ID/Investigator# 72875, Shanghai 200433, China

Site Reference ID/Investigator# 72876, Shanghai 200025, China

Site Reference ID/Investigator# 72883, Shenyang 110001, China

Site Reference ID/Investigator# 72977, Wuhan, Hubei 430022, China

Site Reference ID/Investigator# 72975, Xi'an 710032, China

Additional Information

Starting date: August 2012
Last updated: January 14, 2015

Page last updated: August 23, 2015

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