Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT00292396 | Completed Phase 2 DMC

• 1 other identifier: M05-736
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 24

Brief Summary

The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with clinical response relative to Baseline PASI score

  Week 12, Week 40 and Week 60

Secondary Outcomes (4)

• Quality of Life Surveys

  Week 12, Week 48 and Week 60

• Clinical response indicators

  Week 12, Week 48 and Week 60

• Safety parameters

  Monthly through duration of study

• PGA Assessment

  Week 12, Week 40 and Week 60

Study Arms (6)

1

ACTIVE COMPARATOR

Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks

Drug: Anti IL-12 monoclonal antibody/ABT-874

2

ACTIVE COMPARATOR

Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks

Drug: Anti IL-12 monoclonal antibody/ABT-874

3

ACTIVE COMPARATOR

Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks

Drug: Anti IL-12 monoclonal antibody/ABT-874

4

ACTIVE COMPARATOR

Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks

Drug: Anti IL-12 monoclonal antibody/ABT-874

5

ACTIVE COMPARATOR

Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks

Drug: Anti IL-12 monoclonal antibody/ABT-874

6

PLACEBO COMPARATOR

placebo, 12 doses

Drug: placebo

Interventions

Anti IL-12 monoclonal antibody/ABT-874 DRUG

Please see Arm Description for intervention description and details.

1; 2; 3; 4; 5

placebo DRUG

12 doses

6

Eligibility Criteria

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

You may qualify if:

• Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
• Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis

You may not qualify if:

• Subject had previously received systemic or biologic anti-IL-12 therapy
• Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
• Subject is taking or requires oral or injectable corticosteroids
• Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
• Female subject who is pregnant or breast-feeding or considering becoming pregnant

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (24)

Site Reference ID/Investigator# 3351

San Diego, California, 92123, United States

Location

Site Reference ID/Investigator# 3347

Alpharetta, Georgia, 30022, United States

Location

Site Reference ID/Investigator# 3348

Skokie, Illinois, 60077, United States

Location

Site Reference ID/Investigator# 993

Indianapolis, Indiana, 46256, United States

Location

Site Reference ID/Investigator# 990

Boston, Massachusetts, 02114, United States

Location

Site Reference ID/Investigator# 3349

St Louis, Missouri, 63117, United States

Location

Site Reference ID/Investigator# 992

Cincinnati, Ohio, 45219, United States

Location

Site Reference ID/Investigator# 991

Lake Oswego, Oregon, 97035, United States

Location

Site Reference ID/Investigator# 3367

Portland, Oregon, 97223, United States

Location

Site Reference ID/Investigator# 3346

Johnston, Rhode Island, 02919, United States

Location

Site Reference ID/Investigator# 994

Nashville, Tennessee, 37215, United States

Location

Site Reference ID/Investigator# 3350

Dallas, Texas, 75246-1613, United States

Location

Site Reference ID/Investigator# 796

Houston, Texas, 77030, United States

Location

Site Reference ID/Investigator# 2081

Salt Lake City, Utah, 84132, United States

Location

Site Reference ID/Investigator# 3366

Norfolk, Virginia, 23507, United States

Location

Site Reference ID/Investigator# 989

Seattle, Washington, 98101, United States

Location

Site Reference ID/Investigator# 3361

Halifax, B3H 1Z4, Canada

Location

Site Reference ID/Investigator# 985

Laval, H7S 2C6, Canada

Location

Site Reference ID/Investigator# 987

London, N5X 2P1, Canada

Location

Site Reference ID/Investigator# 3364

Montreal, H2K 4L5, Canada

Location

Site Reference ID/Investigator# 794

North Bay, P1B 3Z7, Canada

Location

Site Reference ID/Investigator# 988

Québec, G1V 4X7, Canada

Location

Site Reference ID/Investigator# 795

Waterloo, N2J 1C4, Canada

Location

Site Reference ID/Investigator# 3360

Windsor, N8W 1E6, Canada

Location

Related Publications (1)

• Kimball AB, Gordon KB, Langley RG, Menter A, Chartash EK, Valdes J; ABT-874 Psoriasis Study Investigators. Safety and efficacy of ABT-874, a fully human interleukin 12/23 monoclonal antibody, in the treatment of moderate to severe chronic plaque psoriasis: results of a randomized, placebo-controlled, phase 2 trial. Arch Dermatol. 2008 Feb;144(2):200-7. doi: 10.1001/archdermatol.2007.63.

  PMID: 18283176 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Martin Kaul, MD

  AbbVie

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 16, 2006
• Study Start: November 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: January 18, 2013

Record last verified: 2013-01

Locations

US (16); CA (8)