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

NCT01646073 | Completed Phase 3 Results

• 1 other identifier: M13-606
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Plaque Psoriasis

Keywords

Plaque Psoriasis; Psoriasis; Placebo Controlled; Skin Disease; Double Blind

Outcome Measures

Primary Outcomes (1)

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

  The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.

  Week 12

Secondary Outcomes (16)

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

  Weeks 3 and 7

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

  Weeks 16, 19, and 24

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

  Baseline to Week 12

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

  Baseline to Week 24

• 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]

  Weeks 3, 7, and 12

Study Arms (2)

Adalimumab

EXPERIMENTAL

Adalimumab 40 mg every other week (eow)

Biological: Adalimumab

Placebo

PLACEBO COMPARATOR

placebo

Biological: placebo

Interventions

Adalimumab BIOLOGICAL

adalimumab eow

Also known as: ABT-D2E7, Humira

Adalimumab

placebo BIOLOGICAL

placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (16)

Site Reference ID/Investigator# 72888

Beijing, 100034, China

Location

Site Reference ID/Investigator# 72873

Beijing, 100044, China

Location

Site Reference ID/Investigator# 72887

Beijing, 100730, China

Location

Site Reference ID/Investigator# 85693

Chengdu, 610072, China

Location

Site Reference ID/Investigator# 72976

Chongqing, 400038, China

Location

Site Reference ID/Investigator# 72880

Dalian, 116011, China

Location

Site Reference ID/Investigator# 72973

Guangzhou, 510120, China

Location

Site Reference ID/Investigator# 72974

Guangzhou, 510630, China

Location

Site Reference ID/Investigator# 72878

Hangzhou, Zhejiang, 310003, China

Location

Site Reference ID/Investigator# 72877

Hangzhou, Zhejiang, 310009, China

Location

Site Reference ID/Investigator# 87058

Jinan, 250012, China

Location

Site Reference ID/Investigator# 72876

Shanghai, 200025, China

Location

Site Reference ID/Investigator# 72875

Shanghai, 200433, China

Location

Site Reference ID/Investigator# 72883

Shenyang, 110001, China

Location

Site Reference ID/Investigator# 72977

Wuhan, Hubei, 430022, China

Location

Site Reference ID/Investigator# 72975

Xi'an, 710032, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Martin Okun, MD

  AbbVie

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: July 20, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 19, 2015
• Results First Posted: January 19, 2015

Record last verified: 2015-01

Locations

CN (16)