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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Anti IL-12 monoclonal antibody/ABT-874
placebo
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 3351
  • Site Reference ID/Investigator# 3347
  • Site Reference ID/Investigator# 3348
  • Site Reference ID/Investigator# 993
  • Site Reference ID/Investigator# 990
  • Site Reference ID/Investigator# 3349
  • Site Reference ID/Investigator# 992
  • Site Reference ID/Investigator# 991
  • Site Reference ID/Investigator# 3367
  • Site Reference ID/Investigator# 3346
  • Site Reference ID/Investigator# 994
  • Site Reference ID/Investigator# 3350
  • Site Reference ID/Investigator# 796
  • Site Reference ID/Investigator# 2081
  • Site Reference ID/Investigator# 3366
  • Site Reference ID/Investigator# 989
  • Site Reference ID/Investigator# 3361
  • Site Reference ID/Investigator# 985
  • Site Reference ID/Investigator# 987
  • Site Reference ID/Investigator# 3364
  • Site Reference ID/Investigator# 794
  • Site Reference ID/Investigator# 988
  • Site Reference ID/Investigator# 795
  • Site Reference ID/Investigator# 3360

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

5

6

Arm Description

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

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

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

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

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

placebo, 12 doses

Outcomes

Primary Outcome Measures

Proportion of subjects with clinical response relative to Baseline PASI score

Secondary Outcome Measures

Quality of Life Surveys
Clinical response indicators
Safety parameters
PGA Assessment

Full Information

First Posted
February 14, 2006
Last Updated
January 10, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT00292396
Brief Title
Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks
Arm Title
2
Arm Type
Active Comparator
Arm Description
Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks
Arm Title
3
Arm Type
Active Comparator
Arm Description
Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks
Arm Title
4
Arm Type
Active Comparator
Arm Description
Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks
Arm Title
5
Arm Type
Active Comparator
Arm Description
Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks
Arm Title
6
Arm Type
Placebo Comparator
Arm Description
placebo, 12 doses
Intervention Type
Drug
Intervention Name(s)
Anti IL-12 monoclonal antibody/ABT-874
Intervention Description
Please see Arm Description for intervention description and details.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
12 doses
Primary Outcome Measure Information:
Title
Proportion of subjects with clinical response relative to Baseline PASI score
Time Frame
Week 12, Week 40 and Week 60
Secondary Outcome Measure Information:
Title
Quality of Life Surveys
Time Frame
Week 12, Week 48 and Week 60
Title
Clinical response indicators
Time Frame
Week 12, Week 48 and Week 60
Title
Safety parameters
Time Frame
Monthly through duration of study
Title
PGA Assessment
Time Frame
Week 12, Week 40 and Week 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Kaul, MD
Organizational Affiliation
AbbVie
Official's Role
Study Chair
Facility Information:
Facility Name
Site Reference ID/Investigator# 3351
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site Reference ID/Investigator# 3347
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Site Reference ID/Investigator# 3348
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Site Reference ID/Investigator# 993
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Site Reference ID/Investigator# 990
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Site Reference ID/Investigator# 3349
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Site Reference ID/Investigator# 992
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Site Reference ID/Investigator# 991
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Site Reference ID/Investigator# 3367
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Site Reference ID/Investigator# 3346
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Site Reference ID/Investigator# 994
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Site Reference ID/Investigator# 3350
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-1613
Country
United States
Facility Name
Site Reference ID/Investigator# 796
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site Reference ID/Investigator# 2081
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Site Reference ID/Investigator# 3366
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Site Reference ID/Investigator# 989
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Site Reference ID/Investigator# 3361
City
Halifax
ZIP/Postal Code
B3H 1Z4
Country
Canada
Facility Name
Site Reference ID/Investigator# 985
City
Laval
ZIP/Postal Code
H7S 2C6
Country
Canada
Facility Name
Site Reference ID/Investigator# 987
City
London
ZIP/Postal Code
N5X 2P1
Country
Canada
Facility Name
Site Reference ID/Investigator# 3364
City
Montreal
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Site Reference ID/Investigator# 794
City
North Bay
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
Site Reference ID/Investigator# 988
City
Quebec City
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Site Reference ID/Investigator# 795
City
Waterloo
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Site Reference ID/Investigator# 3360
City
Windsor
ZIP/Postal Code
N8W 1E6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18283176
Citation
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.
Results Reference
derived

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

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