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

NCT00570986 | Completed Phase 3 DMC

• 1 other identifier: M06-890
• Study Type: interventional
• Target: 1,465
• Locations: 2 countries
• Sites: 116

Brief Summary

The purpose of this study is to determine the safety and efficacy of 2 doses of ABT-874 versus placebo in the treatment of subjects with moderate to severe plaque psoriasis.

Conditions

Plaque Psoriasis

Keywords

Plaque Psoriasis

Outcome Measures

Primary Outcomes (3)

• PGA

  Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12

• PASI

  Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12

• PGA

  Proportion of subjects maintaining a PGA 0/1 response at Week 52

Secondary Outcomes (4)

• DLQI

  Change from Baseline in DLQI total score vs. placebo at Week 12

• NAPSI

  % change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis

• PASI

  Subjects who achieve PASI 90 and 100 at Week 12

• Safety parameters

  Throughout study

Study Arms (3)

1

PLACEBO COMPARATOR

Arm #1 is used for entire study. At week 12, arm is rerandomized.

Drug: Placebo

2

ACTIVE COMPARATOR

Arm #2 is used for entire study. At week 12, arm is rerandomized.

Biological: ABT-874

3

ACTIVE COMPARATOR

Arm #3 is not used for weeks 0-11. At week 12, arm is rerandomized.

Biological: ABT-874

Interventions

Placebo DRUG

Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.

1

ABT-874 BIOLOGICAL

200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.

2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (116)

Site Reference ID/Investigator# 6579

Birmingham, Alabama, 35205, United States

Location

Site Reference ID/Investigator# 6697

Birmingham, Alabama, 35233, United States

Location

Site Reference ID/Investigator# 7015

Huntsville, Alabama, 35801, United States

Location

Site Reference ID/Investigator# 6728

Scottsdale, Arizona, 85251, United States

Location

Site Reference ID/Investigator# 6584

Tucson, Arizona, 85710, United States

Location

Site Reference ID/Investigator# 6696

Little Rock, Arkansas, 72205, United States

Location

Site Reference ID/Investigator# 6591

Bakersfield, California, 93309, United States

Location

Site Reference ID/Investigator# 6710

Fresno, California, 93720, United States

Location

Site Reference ID/Investigator# 7885

Irvine, California, 92697, United States

Location

Site Reference ID/Investigator# 6872

Los Angeles, California, 90045, United States

Location

Site Reference ID/Investigator# 7669

Oceanside, California, 92056, United States

Location

Site Reference ID/Investigator# 6821

San Diego, California, 92103, United States

Location

Site Reference ID/Investigator# 6832

San Diego, California, 92117, United States

Location

Site Reference ID/Investigator# 7305

San Diego, California, 92123, United States

Location

Site Reference ID/Investigator# 7990

San Francisco, California, 94118, United States

Location

Site Reference ID/Investigator# 6711

Santa Monica, California, 90404, United States

Location

Site Reference ID/Investigator# 8139

Torrance, California, 90503, United States

Location

Site Reference ID/Investigator# 7167

Vallejo, California, 94589, United States

Location

Site Reference ID/Investigator# 7302

Denver, Colorado, 80209, United States

Location

Site Reference ID/Investigator# 6921

Longmont, Colorado, 80501, United States

Location

Site Reference ID/Investigator# 6917

New Haven, Connecticut, 06511, United States

Location

Site Reference ID/Investigator# 6707

Jacksonville, Florida, 32204, United States

Location

Site Reference ID/Investigator# 7301

Miami, Florida, 33136, United States

Location

Site Reference ID/Investigator# 7012

Miami, Florida, 33144, United States

Location

Site Reference ID/Investigator# 6831

Miami, Florida, 33173, United States

Location

Site Reference ID/Investigator# 7016

South Miami, Florida, 33143, United States

Location

Site Reference ID/Investigator# 6590

West Palm Beach, Florida, 33407, United States

Location

Site Reference ID/Investigator# 6582

Alpharetta, Georgia, 30022, United States

Location

Site Reference ID/Investigator# 7450

Atlanta, Georgia, 30327, United States

Location

Site Reference ID/Investigator# 6714

Newnan, Georgia, 30263, United States

Location

Site Reference ID/Investigator# 6717

Snellville, Georgia, 30078, United States

Location

Site Reference ID/Investigator# 7017

Arlington Heights, Illinois, 60005, United States

Location

Site Reference ID/Investigator# 7877

Maywood, Illinois, 60153, United States

Location

Site Reference ID/Investigator# 6704

Skokie, Illinois, 60077, United States

Location

Site Reference ID/Investigator# 7292

West Dundee, Illinois, 60118, United States

Location

Site Reference ID/Investigator# 6706

Indianapolis, Indiana, 46256, United States

Location

Site Reference ID/Investigator# 7646

Indianapolis, Indiana, 46260, United States

Location

Site Reference ID/Investigator# 7014

Overland Park, Kansas, 66202, United States

Location

Site Reference ID/Investigator# 6873

Louisville, Kentucky, 40202, United States

Location

Site Reference ID/Investigator# 7523

Owensboro, Kentucky, 42303, United States

Location

Site Reference ID/Investigator# 6597

Andover, Massachusetts, 01810, United States

Location

Site Reference ID/Investigator# 6703

Boston, Massachusetts, 02111, United States

Location

Site Reference ID/Investigator# 7644

Detroit, Michigan, 48202, United States

Location

Site Reference ID/Investigator# 6826

Fort Gratiot, Michigan, 48059, United States

Location

Site Reference ID/Investigator# 7989

Grand Blanc, Michigan, 48439, United States

Location

Site Reference ID/Investigator# 6581

Fridley, Minnesota, 55432, United States

Location

Site Reference ID/Investigator# 7890

St Louis, Missouri, 63110, United States

Location

Site Reference ID/Investigator# 6709

St Louis, Missouri, 63117, United States

Location

Site Reference ID/Investigator# 7451

Omaha, Nebraska, 68144, United States

Location

Site Reference ID/Investigator# 7299

Berlin, New Jersey, 08009, United States

Location

Site Reference ID/Investigator# 6924

East Windsor, New Jersey, 08520, United States

Location

Site Reference ID/Investigator# 6577

New Brunswick, New Jersey, 08903, United States

Location

Site Reference ID/Investigator# 7030

Albuquerque, New Mexico, 87106, United States

Location

Site Reference ID/Investigator# 7878

Buffalo, New York, 14221, United States

Location

Site Reference ID/Investigator# 7876

New York, New York, 10016, United States

Location

Site Reference ID/Investigator# 6599

New York, New York, 10025, United States

Location

Site Reference ID/Investigator# 6895

New York, New York, 10029-6501, United States

Location

Site Reference ID/Investigator# 7637

New York, New York, 10032, United States

Location

Site Reference ID/Investigator# 7504

Rochester, New York, 14623, United States

Location

Site Reference ID/Investigator# 7018

Stoney Brook, New York, 11790, United States

Location

Site Reference ID/Investigator# 6926

Hickory, North Carolina, 28601, United States

Location

Site Reference ID/Investigator# 7293

Wilmington, North Carolina, 28401, United States

Location

Site Reference ID/Investigator# 8251

Winston-Salem, North Carolina, 27157, United States

Location

Site Reference ID/Investigator# 6598

Cincinnati, Ohio, 45219, United States

Location

Site Reference ID/Investigator# 8082

Cleveland, Ohio, 44106, United States

Location

Site Reference ID/Investigator# 7165

Columbus, Ohio, 43212, United States

Location

Site Reference ID/Investigator# 7659

Dayton, Ohio, 45408, United States

Location

Site Reference ID/Investigator# 6727

Lake Oswego, Oregon, 97035, United States

Location

Site Reference ID/Investigator# 6894

Portland, Oregon, 97210, United States

Location

Site Reference ID/Investigator# 6578

Portland, Oregon, 97223, United States

Location

Site Reference ID/Investigator# 7295

Portland, Oregon, 97239, United States

Location

Site Reference ID/Investigator# 7879

Hershey, Pennsylvania, 17033, United States

Location

Site Reference ID/Investigator# 6712

Philadelphia, Pennsylvania, 19103, United States

Location

Site Reference ID/Investigator# 6580

Johnston, Rhode Island, 02919, United States

Location

Site Reference ID/Investigator# 6576

Providence, Rhode Island, 02903, United States

Location

Site Reference ID/Investigator# 6589

Greer, South Carolina, 29651, United States

Location

Site Reference ID/Investigator# 6586

Goodlettsville, Tennessee, 37072, United States

Location

Site Reference ID/Investigator# 7668

Knoxville, Tennessee, 37934, United States

Location

Site Reference ID/Investigator# 6915

Nashville, Tennessee, 37215, United States

Location

Site Reference ID/Investigator# 6825

Arlington, Texas, 76011, United States

Location

Site Reference ID/Investigator# 6762

Austin, Texas, 78759, United States

Location

Site Reference ID/Investigator# 6822

Dallas, Texas, 75230, United States

Location

Site Reference ID/Investigator# 7671

Dallas, Texas, 75246-1613, United States

Location

Site Reference ID/Investigator# 6705

Houston, Texas, 77030, United States

Location

Site Reference ID/Investigator# 6708

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 7081

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 6912

Tyler, Texas, 75703, United States

Location

Site Reference ID/Investigator# 7306

Webster, Texas, 77598, United States

Location

Site Reference ID/Investigator# 8101

Salt Lake City, Utah, 84132, United States

Location

Site Reference ID/Investigator# 6807

Norfolk, Virginia, 23507, United States

Location

Site Reference ID/Investigator# 6801

Seattle, Washington, 98101, United States

Location

Site Reference ID/Investigator# 7519

Spokane, Washington, 99204, United States

Location

Site Reference ID/Investigator# 7080

Milwaukee, Wisconsin, 53209, United States

Location

Site Reference ID/Investigator# 7314

Barrie, L4M 6L2, Canada

Location

Site Reference ID/Investigator# 7452

Calgary, T3A 2N1, Canada

Location

Site Reference ID/Investigator# 6702

Edmonton, T5K 1X3, Canada

Location

Site Reference ID/Investigator# 6716

Halifax, B3H 0A2, Canada

Location

Site Reference ID/Investigator# 7309

Hamilton, L8N 1V6, Canada

Location

Site Reference ID/Investigator# 6588

Laval, H7S 2C6, Canada

Location

Site Reference ID/Investigator# 6715

London, N5X 2P1, Canada

Location

Site Reference ID/Investigator# 7315

London, N6A 3H7, Canada

Location

Site Reference ID/Investigator# 7636

Markham, L3P 1A8, Canada

Location

Site Reference ID/Investigator# 6699

Montreal, H2K 4L5, Canada

Location

Site Reference ID/Investigator# 7316

Montreal, H3H 1V4, Canada

Location

Site Reference ID/Investigator# 7088

North Bay, P1B 3Z7, Canada

Location

Site Reference ID/Investigator# 7310

Ottawa, K2G 6E2, Canada

Location

Site Reference ID/Investigator# 7311

Québec, G1V 4X7, Canada

Location

Site Reference ID/Investigator# 7313

St. John's, A1A 5E8, Canada

Location

Site Reference ID/Investigator# 7317

Surrey, V3R 6A7, Canada

Location

Site Reference ID/Investigator# 7308

Vancouver, V5Z 3Y1, Canada

Location

Site Reference ID/Investigator# 6713

Vancouver, V5Z 4E8, Canada

Location

Site Reference ID/Investigator# 7067

Waterloo, N2J 1C4, Canada

Location

Site Reference ID/Investigator# 7312

Westmount, H3Z 2S6, Canada

Location

Site Reference ID/Investigator# 7087

Windsor, N8W 1E6, Canada

Location

Site Reference ID/Investigator# 6805

Windsor, N8W 5L7, Canada

Location

Site Reference ID/Investigator# 7638

Winnipeg, R3C 1R4, Canada

Location

MeSH Terms

Interventions

briakinumab

Study Officials

• Martin Kaul, MD

  AbbVie

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 11, 2007
• Study Start: November 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 8, 2013

Record last verified: 2013-01

Locations

US (93); CA (23)