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A Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
This study has been completed.
First Received: December 7, 2007   Last Updated: June 29, 2009   History of Changes
Sponsor: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00570986
  Purpose

Safety and efficacy of ABT-874 in the treatment of moderate to severe plaque psoriasis two doses of ABT-874 versus placebo


Condition Intervention Phase
Plaque Psoriasis
 Drug: Placebo
Biological: ABT-874
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • PGA [ Time Frame: Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12 ] [ Designated as safety issue: No ]
  • PASI [ Time Frame: Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12 ] [ Designated as safety issue: No ]
  • PGA [ Time Frame: Proportion of subjects maintaining a PGA 0/1 response at Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DLQI [ Time Frame: Change from Baseline in DLQI total score vs. placebo at Week 12 ] [ Designated as safety issue: No ]
  • NAPSI [ Time Frame: % change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis ] [ Designated as safety issue: No ]
  • PASI [ Time Frame: Subjects who achieve PASI 90 and 100 at Week 12 ] [ Designated as safety issue: No ]
  • Safety parameters [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 1465
Study Start Date: December 2007
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
Arm #1 is used for entire study. At week 12, arm is rerandomized.
Drug: Placebo
Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.
2: Active Comparator
Arm #2 is used for entire study. At week 12, arm is rerandomized.
Biological: ABT-874
200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.
3: Active Comparator
Arm #3 is not used for weeks 0-11. At week 12, arm is rerandomized.
Biological: ABT-874
100mg every 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is >= 18 years of age
  • Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
  • Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

  • Subject has previous exposure to systemic 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 injectible corticosteroids
  • Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570986

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35205
Huntsville, Alabama, United States, 35801
Birmingham, Alabama, United States, 35233
Mobile, Alabama, United States, 36608
United States, Arizona
Tucson, Arizona, United States, 85710
Scottsdale, Arizona, United States, 85251
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
San Diego, California, United States, 92117
Fresno, California, United States, 93720
Vallejo, California, United States, 94589
San Diego, California, United States, 92103
Los Angeles, California, United States, 90045
San Diego, California, United States, 92123
Santa Monica, California, United States, 90404
Bakersfield, California, United States, 93309
Oceanside, California, United States, 92056
San Francisco, California, United States, 94118-2616
Irvine, California, United States, 92697
Torrance, California, United States, 90503
United States, Colorado
Longmont, Colorado, United States, 80501
Denver, Colorado, United States, 80209
United States, Connecticut
New Haven, Connecticut, United States, 06511
United States, Florida
West Palm Beach, Florida, United States, 33407
Miami, Florida, United States, 33175
Miami, Florida, United States, 33144
South Miami, Florida, United States, 33143
Miami, Florida, United States, 33136-1003
Pinellas Park, Florida, United States, 33781
Jacksonville, Florida, United States, 32204
Miami, Florida, United States, 33173
United States, Georgia
Alpharetta, Georgia, United States, 30022
Snellville, Georgia, United States, 30078
Newnan, Georgia, United States, 30263
Atlanta, Georgia, United States, 30327
United States, Illinois
Maywood, Illinois, United States, 60153
West Dundee, Illinois, United States, 60118
Arlington Heights, Illinois, United States, 60005
Skokie, Illinois, United States, 60077
United States, Indiana
Indianapolis, Indiana, United States, 46256
Indianapolis, Indiana, United States, 46260
United States, Kansas
Overland Park, Kansas, United States, 66202
United States, Kentucky
Louisville, Kentucky, United States, 40202
Owensboro, Kentucky, United States, 42303
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Andover, Massachusetts, United States, 01810
United States, Michigan
Fort Gratiot, Michigan, United States, 48059
Detroit, Michigan, United States, 48202
Grand Blanc, Michigan, United States, 48439
United States, Minnesota
Fridley, Minnesota, United States, 55432
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St. Louis, Missouri, United States, 63117
St. Louis, Missouri, United States, 63110
United States, Nebraska
Omaha, Nebraska, United States, 68144
United States, New Jersey
East Windsor, New Jersey, United States, 08520
Berlin, New Jersey, United States, 08009
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Stonybrook, New York, United States, 11790
Rochester, New York, United States, 14623
New York, New York, United States, 10029
New York, New York, United States, 10032
Buffalo, New York, United States, 14221
New York, New York, United States, 10016
New York, New York, United States, 10025
United States, North Carolina
Hickory, North Carolina, United States, 28601
Winston Salem, North Carolina, United States, 27157
Wilmington, North Carolina, United States, 28401
Winston-Salem, North Carolina, United States, 27103
Raleigh, North Carolina, United States, 27612
United States, Ohio
Columbus, Ohio, United States, 43212
Dayton, Ohio, United States, 45408
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44106
United States, Oregon
Portland, Oregon, United States, 97239
Lake Oswego, Oregon, United States, 97035
Portland, Oregon, United States, 97210
Portland, Oregon, United States, 97223
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19103
Hershey, Pennsylvania, United States, 17033
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Johnston, Rhode Island, United States, 02919
Providence, Rhode Island, United States, 02903
United States, South Carolina
Greer, South Carolina, United States, 29651
United States, Tennessee
Nashville, Tennessee, United States, 37215
Goodlettsville, Tennessee, United States, 37072
Knoxville, Tennessee, United States, 37934
United States, Texas
Tyler, Texas, United States, 75703
Austin, Texas, United States, 78759
Dallas, Texas, United States, 75230
Webster, Texas, United States, 77598
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
Arlington, Texas, United States, 76011
Dallas, Texas, United States, 75246
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Norfolk, Virginia, United States, 23507
United States, Washington
Seattle, Washington, United States, 98101
Spokane, Washington, United States, 99204
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53209
Canada
Quebec, Canada, G1V 4X7
Canada, Alberta
Edmonton, Alberta, Canada, T5K 1X3
Calgary, Alberta, Canada, T3A 2N1
Canada, British Columbia
Surrey, British Columbia, Canada, V3R 6A7
Vancouver, British Columbia, Canada, V5Z 3Y1
Vancouver, British Columbia, Canada, V5Z 4E8
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3C 1R4
Canada, Newfoundland and Labrador
St John's, Newfoundland and Labrador, Canada, A1B 3E1
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H-1Z4
Canada, Ontario
Waterloo, Ontario, Canada, N2J-1C4
North Bay, Ontario, Canada, P1B 3Z7
Windsor, Ontario, Canada, N8W 1E6
Ottawa, Ontario, Canada, K2G 6E2
London, Ontario, Canada, N5X 2P1
Barrie, Ontario, Canada, L4M 6L2
London, Ontario, Canada, N6A 3H7
Windsor, Ontario, Canada, N8W 5L7
Hamilton, Ontario, Canada, L8N IV6
Markham, Ontario, Canada, L3P 1A8
Canada, Quebec
Montreal, Quebec, Canada, H2K 4L5
Montreal, Quebec, Canada, H3H 1V4
Montreal, Quebec, Canada, H3Z 2S6
Laval, Quebec, Canada, H7S 2C6
Sponsors and Collaborators
Abbott
Investigators
Study Director: Joaquin Valdes, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott ( Beverly Paperiello, Director, Immunology Development )
Study ID Numbers: M06-890
Study First Received: December 7, 2007
Last Updated: June 29, 2009
ClinicalTrials.gov Identifier: NCT00570986     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Plaque Psoriasis

Additional relevant MeSH terms:
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 27, 2009



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