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

Psoriasis Clinical Trial

Official title:

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Subcutaneous Injections of ABT-874 vs. Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292396
• Other study ID #: M05-736
• Status: Completed
• Phase: Phase 2
• First received: February 14, 2006
• Last updated: January 10, 2013
• Start date: November 2005
• Est. completion date: April 2008

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Anti IL-12 monoclonal antibody/ABT-874
Please see Arm Description for intervention description and details.
• placebo
12 doses

Locations

Country	Name	City	State
Canada	Site Reference ID/Investigator# 3361	Halifax
Canada	Site Reference ID/Investigator# 985	Laval
Canada	Site Reference ID/Investigator# 987	London
Canada	Site Reference ID/Investigator# 3364	Montreal
Canada	Site Reference ID/Investigator# 794	North Bay
Canada	Site Reference ID/Investigator# 988	Quebec City
Canada	Site Reference ID/Investigator# 795	Waterloo
Canada	Site Reference ID/Investigator# 3360	Windsor
United States	Site Reference ID/Investigator# 3347	Alpharetta	Georgia
United States	Site Reference ID/Investigator# 990	Boston	Massachusetts
United States	Site Reference ID/Investigator# 992	Cincinnati	Ohio
United States	Site Reference ID/Investigator# 3350	Dallas	Texas
United States	Site Reference ID/Investigator# 796	Houston	Texas
United States	Site Reference ID/Investigator# 993	Indianapolis	Indiana
United States	Site Reference ID/Investigator# 3346	Johnston	Rhode Island
United States	Site Reference ID/Investigator# 991	Lake Oswego	Oregon
United States	Site Reference ID/Investigator# 994	Nashville	Tennessee
United States	Site Reference ID/Investigator# 3366	Norfolk	Virginia
United States	Site Reference ID/Investigator# 3367	Portland	Oregon
United States	Site Reference ID/Investigator# 2081	Salt Lake City	Utah
United States	Site Reference ID/Investigator# 3351	San Diego	California
United States	Site Reference ID/Investigator# 989	Seattle	Washington
United States	Site Reference ID/Investigator# 3348	Skokie	Illinois
United States	Site Reference ID/Investigator# 3349	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with clinical response relative to Baseline PASI score		Week 12, Week 40 and Week 60	No
Secondary	Quality of Life Surveys		Week 12, Week 48 and Week 60	Yes
Secondary	Clinical response indicators		Week 12, Week 48 and Week 60	No
Secondary	Safety parameters		Monthly through duration of study	Yes
Secondary	PGA Assessment		Week 12, Week 40 and Week 60	No