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Moderate to Severe Plaque PsoriasisPhase 3NCT00626002

Open Label Continuation Study in Moderate to Severe Psoriasis

A Phase 3 study testing ABT-874 in people with Moderate to Severe Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 152 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe psoriasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Moderate to Severe Plaque Psoriasis
What is being tested?
ABT-874
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,301 participants
Where
152 sitesin 14 countries
Study dates
Feb 2008to Oct 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Having participated in a preceding ABT-874 clinical trial for ABT-874
  • Subject has a clinical diagnosis of moderate to severe plaque psoriasis

Who cannot join

  • Subjects who prematurely discontinued in any preceding psoriasis study with ABT-874 other than protocol-required discontinuation

Trial locations and contacts

152 sites in 14 countries.

152 sites in 14 countries

United States98 sites

  • Site Reference ID/Investigator# 7455

    Albuquerque, New Mexico, 87106

  • Site Reference ID/Investigator# 7331

    Alpharetta, Georgia, 30022

  • Site Reference ID/Investigator# 8529

    Andover, Massachusetts, 01810

  • Site Reference ID/Investigator# 7684

    Arlington, Texas, 76011

  • Site Reference ID/Investigator# 8379

    Arlington Heights, Illinois, 60005

  • Site Reference ID/Investigator# 9743

    Atlanta, Georgia, 30327

  • Site Reference ID/Investigator# 10842

    Austin, Texas, 78759

  • Site Reference ID/Investigator# 7234

    Bakersfield, California, 93309

  • Site Reference ID/Investigator# 7757

    Berlin, New Jersey, 08009

  • Site Reference ID/Investigator# 7496

    Birmingham, Alabama, 35205

  • Site Reference ID/Investigator# 8438

    Birmingham, Alabama, 35233

  • Site Reference ID/Investigator# 8149

    Boston, Massachusetts, 02111

  • Site Reference ID/Investigator# 8078

    Buffalo, New York, 14221

  • Site Reference ID/Investigator# 6945

    Cincinnati, Ohio, 45219

  • Site Reference ID/Investigator# 23345

    Cincinnati, Ohio, 45220

  • Site Reference ID/Investigator# 7044

    Cleveland, Ohio, 44106

  • Site Reference ID/Investigator# 7899

    Columbus, Ohio, 43212

  • Site Reference ID/Investigator# 7498

    Dallas, Texas, 75230

  • Site Reference ID/Investigator# 6947

    Dallas, Texas, 75246-1613

  • Site Reference ID/Investigator# 8389

    Dayton, Ohio, 45408

  • Site Reference ID/Investigator# 7929

    Denver, Colorado, 80209

  • Site Reference ID/Investigator# 9823

    Detroit, Michigan, 48202

  • Site Reference ID/Investigator# 7653

    Doral, Florida, 33166-6665

  • Site Reference ID/Investigator# 7330

    East Windsor, New Jersey, 08520

  • Site Reference ID/Investigator# 7883

    Fort Gratiot, Michigan, 48059

  • Site Reference ID/Investigator# 8249

    Fresno, California, 93720

  • Site Reference ID/Investigator# 7656

    Fridley, Minnesota, 55432

  • Site Reference ID/Investigator# 7497

    Goodlettsville, Tennessee, 37072

  • Site Reference ID/Investigator# 7238

    Grand Blanc, Michigan, 48439

  • Site Reference ID/Investigator# 7785

    Greer, South Carolina, 29650

  • Site Reference ID/Investigator# 17193

    Henderson, Kentucky, 42420

  • Site Reference ID/Investigator# 8494

    Hershey, Pennsylvania, 17033

  • Site Reference ID/Investigator# 7434

    Hickory, North Carolina, 28602

  • Site Reference ID/Investigator# 6944

    Houston, Texas, 77030

  • Site Reference ID/Investigator# 7522

    Huntsville, Alabama, 35801

  • Site Reference ID/Investigator# 6933

    Indianapolis, Indiana, 46256

  • Site Reference ID/Investigator# 10422

    Indianapolis, Indiana, 46260

  • Site Reference ID/Investigator# 7332

    Irvine, California, 92697

  • Site Reference ID/Investigator# 8341

    Jacksonville, Florida, 32204

  • Site Reference ID/Investigator# 6934

    Johnston, Rhode Island, 02919

  • Site Reference ID/Investigator# 7388

    Knoxville, Tennessee, 37934

  • Site Reference ID/Investigator# 6936

    Lake Oswego, Oregon, 97035

  • Site Reference ID/Investigator# 7933

    Little Rock, Arkansas, 72204

  • Site Reference ID/Investigator# 7436

    Longmont, Colorado, 80501

  • Site Reference ID/Investigator# 7239

    Los Angeles, California, 90045

  • Site Reference ID/Investigator# 8528

    Louisville, Kentucky, 40202

  • Site Reference ID/Investigator# 8798

    Maywood, Illinois, 60153

  • Site Reference ID/Investigator# 7716

    Miami, Florida, 33136

  • Site Reference ID/Investigator# 7657

    Miami, Florida, 33144

  • Site Reference ID/Investigator# 7884

    Milwaukee, Wisconsin, 53209

  • Site Reference ID/Investigator# 6931

    Nashville, Tennessee, 37215

  • Site Reference ID/Investigator# 7882

    New Brunswick, New Jersey, 08903

  • Site Reference ID/Investigator# 7521

    New Haven, Connecticut, 06511

  • Site Reference ID/Investigator# 8392

    New York, New York, 10016

  • Site Reference ID/Investigator# 8006

    New York, New York, 10025

  • Site Reference ID/Investigator# 7230

    New York, New York, 10029-6501

  • Site Reference ID/Investigator# 10201

    New York, New York, 10032

  • Site Reference ID/Investigator# 7891

    Newnan, Georgia, 30263

  • Site Reference ID/Investigator# 6946

    Norfolk, Virginia, 23507

  • Site Reference ID/Investigator# 8390

    Oceanside, California, 92056

  • Site Reference ID/Investigator# 11181

    Oklahoma City, Oklahoma, 73104

  • Site Reference ID/Investigator# 7240

    Omaha, Nebraska, 68131

  • Site Reference ID/Investigator# 9567

    Omaha, Nebraska, 68144

  • Site Reference ID/Investigator# 7992

    Overland Park, Kansas, 66202

  • Site Reference ID/Investigator# 9962

    Owensboro, Kentucky, 42303

  • Site Reference ID/Investigator# 7930

    Philadelphia, Pennsylvania, 19103

  • Site Reference ID/Investigator# 16581

    Plainfield, Indiana, 46168

  • Site Reference ID/Investigator# 7703

    Portland, Oregon, 97210

  • Site Reference ID/Investigator# 6948

    Portland, Oregon, 97223

  • Site Reference ID/Investigator# 11424

    Portland, Oregon, 97239

  • Site Reference ID/Investigator# 6935

    Providence, Rhode Island, 02903

  • Site Reference ID/Investigator# 8037

    Rochester, New York, 14623

  • Site Reference ID/Investigator# 10207

    Salt Lake City, Utah, 84132

  • Site Reference ID/Investigator# 7758

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 8108

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 7503

    San Diego, California, 92103

  • Site Reference ID/Investigator# 7520

    San Diego, California, 92117

  • Site Reference ID/Investigator# 7010

    San Diego, California, 92123

  • Site Reference ID/Investigator# 10962

    San Francisco, California, 94118

  • Site Reference ID/Investigator# 7334

    Santa Monica, California, 90404

  • Site Reference ID/Investigator# 10703

    Schaumburg, Illinois, 60194

  • Site Reference ID/Investigator# 7774

    Scottsdale, Arizona, 85251

  • Site Reference ID/Investigator# 6932

    Seattle, Washington, 98101

  • Site Reference ID/Investigator# 6950

    Skokie, Illinois, 60077

  • Site Reference ID/Investigator# 7932

    Snellville, Georgia, 30078

  • Site Reference ID/Investigator# 10841

    South Miami, Florida, 33143

  • Site Reference ID/Investigator# 10306

    Spokane, Washington, 99204

  • Site Reference ID/Investigator# 6930

    St Louis, Missouri, 63110

  • Site Reference ID/Investigator# 6949

    St Louis, Missouri, 63117

  • Site Reference ID/Investigator# 7333

    Stoney Brook, New York, 11790

  • Site Reference ID/Investigator# 7435

    Tucson, Arizona, 85710

  • Site Reference ID/Investigator# 6937

    Tyler, Texas, 75703

  • Site Reference ID/Investigator# 7793

    Vallejo, California, 94589

  • Site Reference ID/Investigator# 7655

    Webster, Texas, 77598

  • Site Reference ID/Investigator# 7892

    West Dundee, Illinois, 60118

  • Site Reference ID/Investigator# 7893

    West Palm Beach, Florida, 33409-3509

  • Site Reference ID/Investigator# 8117

    Wilmington, North Carolina, 28401

  • Site Reference ID/Investigator# 9681

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada23 sites

  • Site Reference ID/Investigator# 7991

    Barrie, L4M 6L2

  • Site Reference ID/Investigator# 8047

    Calgary, T3G 0B4

  • Site Reference ID/Investigator# 7996

    Edmonton, T5K 1X3

  • Site Reference ID/Investigator# 6996

    Halifax, B3H 0A2

  • Site Reference ID/Investigator# 7236

    Hamilton, L8N 1V6

  • Site Reference ID/Investigator# 6995

    Laval, H7S 2C6

  • Site Reference ID/Investigator# 6998

    London, N5X 2P1

  • Site Reference ID/Investigator# 7043

    London, N6A 3H7

  • Site Reference ID/Investigator# 7329

    Markham, L3P 1A8

  • Site Reference ID/Investigator# 6999

    Montreal, H2K 4L5

  • Site Reference ID/Investigator# 7652

    Montreal, H3H 1V4

  • Site Reference ID/Investigator# 7006

    North Bay, P1B 3Z7

  • Site Reference ID/Investigator# 8102

    Ottawa, K2G 6E2

  • Site Reference ID/Investigator# 6993

    Québec, G1V 4X7

  • Site Reference ID/Investigator# 8112

    St. John's, A1A 5E8

  • Site Reference ID/Investigator# 7931

    Surrey, V3R 6A7

  • Site Reference ID/Investigator# 8118

    Vancouver, V5Z 3Y1

  • Site Reference ID/Investigator# 6997

    Vancouver, V5Z 4E8

  • Site Reference ID/Investigator# 6994

    Waterloo, N2J 1C4

  • Site Reference ID/Investigator# 8111

    Westmount, H3Z 2S6

  • Site Reference ID/Investigator# 7005

    Windsor, N8W 1E6

  • Site Reference ID/Investigator# 7979

    Windsor, N8W 5L7

  • Site Reference ID/Investigator# 8348

    Winnipeg, R3C 1R4

Other trials in Canada

Germany7 sites

  • Site Reference ID/Investigator# 16281

    Berlin, 10117

  • Site Reference ID/Investigator# 15664

    Frankfurt am Main, 60590

  • Site Reference ID/Investigator# 15663

    Hamburg, D-20354

  • Site Reference ID/Investigator# 16381

    Kiel, 24105

  • Site Reference ID/Investigator# 16143

    Munich, D-80337

  • Site Reference ID/Investigator# 16161

    Münster, 48149

  • Site Reference ID/Investigator# 17676

    Tübingen, 72076

Other trials in Germany

Finland4 sites

  • Site Reference ID/Investigator# 18661

    Helsinki, 00029 HUS

  • Site Reference ID/Investigator# 18701

    Kuopio, 70210

  • Site Reference ID/Investigator# 14962

    Lahti, 15850

  • Site Reference ID/Investigator# 19241

    Turku, 20521

Other trials in Finland

France3 sites

  • Site Reference ID/Investigator# 18502

    Nice, 06200

  • Site Reference ID/Investigator# 16781

    Paris, 75475

  • Site Reference ID/Investigator# 18506

    Toulouse, 31059

Other trials in France

Greece3 sites

  • Site Reference ID/Investigator# 16282

    Athens, 161 21

  • Site Reference ID/Investigator# 15921

    Athens, 16121

  • Site Reference ID/Investigator# 15922

    Thessaloniki, 54643

Other trials in Greece

Austria2 sites

  • Site Reference ID/Investigator# 16845

    Graz, 8036

  • Site Reference ID/Investigator# 18183

    Vienna, 1090

Other trials in Austria

Denmark2 sites

  • Site Reference ID/Investigator# 17781

    Aarhus, 8000

  • Site Reference ID/Investigator# 18041

    Copenhagen NV, 2400

Other trials in Denmark

Italy2 sites

  • Site Reference ID/Investigator# 15401

    Modena, 41100

  • Site Reference ID/Investigator# 14881

    Rome, 00133

Other trials in Italy

Spain2 sites

  • Site Reference ID/Investigator# 19322

    Barcelona, 08916

  • Site Reference ID/Investigator# 15341

    Madrid, 28006

Other trials in Spain

Switzerland2 sites

  • Site Reference ID/Investigator# 17721

    Geneva, 1211

  • Site Reference ID/Investigator# 16749

    Zurich, 8091

Other trials in Switzerland

United Kingdom2 sites

  • Site Reference ID/Investigator# 19045

    Aberdeen, AB25 2ZR

  • Site Reference ID/Investigator# 15422

    Manchester, M6 8HD

Other trials in United Kingdom

Belgium1 site

  • Site Reference ID/Investigator# 15761

    Brussels, 1200

Other trials in Belgium

Sweden1 site

  • Site Reference ID/Investigator# 16142

    Stockholm, 171 76

Other trials in Sweden

About this study

Official title: A Phase 3, Multi-center, Open-label Continuation Study in Moderate to Severe Plaque Psoriasis in Subjects Who Completed a Preceding Psoriasis Study With ABT-874

The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe psoriasis.

Being tested
ABT-874
Keywords
Open label

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-874Drug

    Also called briakinumab

    100mg ABT-874 administered SQ every 4 wks for approximately 204 weeks

Study groups in NCT00626002
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: ABT-874

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects achieving PGA "clear" (0) or "minimal" (1) scores by visit.

    Measured: Visit (12 weeks)

  2. Proportion of subjects achieving a > PASI 50 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.

    Measured: Visit (12 weeks)

  3. Proportion of subjects achieving a > PASI 75 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.

    Measured: Visit (12 weeks)

  4. AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study

    Measured: Visit (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
2,301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00626002
Sponsor's protocol ID
M10-016
Other IDs
2007-005955-40
Status last verified
Jan 2013
First submitted
22 Feb 2008
Last updated
30 Jan 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABT-874 in people with Moderate to Severe Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 152 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in United States, Canada, Germany, Finland, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects achieving PGA "clear" (0) or "minimal" (1) scores by visit. (time frame: Visit (12 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00626002.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2013.

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