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Plaque PsoriasisPhase 3NCT00570986

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

A Phase 3 study testing ABT-874 in people with Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 116 sites in 2 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 determine the safety and efficacy of 2 doses of ABT-874 versus placebo in the treatment of subjects with moderate to severe plaque psoriasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
ABT-874
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,465 participants
Where
116 sitesin 2 countries
Study dates
Nov 2007to Jun 2009
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

116 sites in 2 countries.

116 sites in 2 countries

United States93 sites

  • Site Reference ID/Investigator# 7030

    Albuquerque, New Mexico, 87106

  • Site Reference ID/Investigator# 6582

    Alpharetta, Georgia, 30022

  • Site Reference ID/Investigator# 6597

    Andover, Massachusetts, 01810

  • Site Reference ID/Investigator# 6825

    Arlington, Texas, 76011

  • Site Reference ID/Investigator# 7017

    Arlington Heights, Illinois, 60005

  • Site Reference ID/Investigator# 7450

    Atlanta, Georgia, 30327

  • Site Reference ID/Investigator# 6762

    Austin, Texas, 78759

  • Site Reference ID/Investigator# 6591

    Bakersfield, California, 93309

  • Site Reference ID/Investigator# 7299

    Berlin, New Jersey, 08009

  • Site Reference ID/Investigator# 6579

    Birmingham, Alabama, 35205

  • Site Reference ID/Investigator# 6697

    Birmingham, Alabama, 35233

  • Site Reference ID/Investigator# 6703

    Boston, Massachusetts, 02111

  • Site Reference ID/Investigator# 7878

    Buffalo, New York, 14221

  • Site Reference ID/Investigator# 6598

    Cincinnati, Ohio, 45219

  • Site Reference ID/Investigator# 8082

    Cleveland, Ohio, 44106

  • Site Reference ID/Investigator# 7165

    Columbus, Ohio, 43212

  • Site Reference ID/Investigator# 6822

    Dallas, Texas, 75230

  • Site Reference ID/Investigator# 7671

    Dallas, Texas, 75246-1613

  • Site Reference ID/Investigator# 7659

    Dayton, Ohio, 45408

  • Site Reference ID/Investigator# 7302

    Denver, Colorado, 80209

  • Site Reference ID/Investigator# 7644

    Detroit, Michigan, 48202

  • Site Reference ID/Investigator# 6924

    East Windsor, New Jersey, 08520

  • Site Reference ID/Investigator# 6826

    Fort Gratiot, Michigan, 48059

  • Site Reference ID/Investigator# 6710

    Fresno, California, 93720

  • Site Reference ID/Investigator# 6581

    Fridley, Minnesota, 55432

  • Site Reference ID/Investigator# 6586

    Goodlettsville, Tennessee, 37072

  • Site Reference ID/Investigator# 7989

    Grand Blanc, Michigan, 48439

  • Site Reference ID/Investigator# 6589

    Greer, South Carolina, 29651

  • Site Reference ID/Investigator# 7879

    Hershey, Pennsylvania, 17033

  • Site Reference ID/Investigator# 6926

    Hickory, North Carolina, 28601

  • Site Reference ID/Investigator# 6705

    Houston, Texas, 77030

  • Site Reference ID/Investigator# 7015

    Huntsville, Alabama, 35801

  • Site Reference ID/Investigator# 6706

    Indianapolis, Indiana, 46256

  • Site Reference ID/Investigator# 7646

    Indianapolis, Indiana, 46260

  • Site Reference ID/Investigator# 7885

    Irvine, California, 92697

  • Site Reference ID/Investigator# 6707

    Jacksonville, Florida, 32204

  • Site Reference ID/Investigator# 6580

    Johnston, Rhode Island, 02919

  • Site Reference ID/Investigator# 7668

    Knoxville, Tennessee, 37934

  • Site Reference ID/Investigator# 6727

    Lake Oswego, Oregon, 97035

  • Site Reference ID/Investigator# 6696

    Little Rock, Arkansas, 72205

  • Site Reference ID/Investigator# 6921

    Longmont, Colorado, 80501

  • Site Reference ID/Investigator# 6872

    Los Angeles, California, 90045

  • Site Reference ID/Investigator# 6873

    Louisville, Kentucky, 40202

  • Site Reference ID/Investigator# 7877

    Maywood, Illinois, 60153

  • Site Reference ID/Investigator# 7301

    Miami, Florida, 33136

  • Site Reference ID/Investigator# 7012

    Miami, Florida, 33144

  • Site Reference ID/Investigator# 6831

    Miami, Florida, 33173

  • Site Reference ID/Investigator# 7080

    Milwaukee, Wisconsin, 53209

  • Site Reference ID/Investigator# 6915

    Nashville, Tennessee, 37215

  • Site Reference ID/Investigator# 6577

    New Brunswick, New Jersey, 08903

  • Site Reference ID/Investigator# 6917

    New Haven, Connecticut, 06511

  • Site Reference ID/Investigator# 7876

    New York, New York, 10016

  • Site Reference ID/Investigator# 6599

    New York, New York, 10025

  • Site Reference ID/Investigator# 6895

    New York, New York, 10029-6501

  • Site Reference ID/Investigator# 7637

    New York, New York, 10032

  • Site Reference ID/Investigator# 6714

    Newnan, Georgia, 30263

  • Site Reference ID/Investigator# 6807

    Norfolk, Virginia, 23507

  • Site Reference ID/Investigator# 7669

    Oceanside, California, 92056

  • Site Reference ID/Investigator# 7451

    Omaha, Nebraska, 68144

  • Site Reference ID/Investigator# 7014

    Overland Park, Kansas, 66202

  • Site Reference ID/Investigator# 7523

    Owensboro, Kentucky, 42303

  • Site Reference ID/Investigator# 6712

    Philadelphia, Pennsylvania, 19103

  • Site Reference ID/Investigator# 6894

    Portland, Oregon, 97210

  • Site Reference ID/Investigator# 6578

    Portland, Oregon, 97223

  • Site Reference ID/Investigator# 7295

    Portland, Oregon, 97239

  • Site Reference ID/Investigator# 6576

    Providence, Rhode Island, 02903

  • Site Reference ID/Investigator# 7504

    Rochester, New York, 14623

  • Site Reference ID/Investigator# 8101

    Salt Lake City, Utah, 84132

  • Site Reference ID/Investigator# 6708

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 7081

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 6821

    San Diego, California, 92103

  • Site Reference ID/Investigator# 6832

    San Diego, California, 92117

  • Site Reference ID/Investigator# 7305

    San Diego, California, 92123

  • Site Reference ID/Investigator# 7990

    San Francisco, California, 94118

  • Site Reference ID/Investigator# 6711

    Santa Monica, California, 90404

  • Site Reference ID/Investigator# 6728

    Scottsdale, Arizona, 85251

  • Site Reference ID/Investigator# 6801

    Seattle, Washington, 98101

  • Site Reference ID/Investigator# 6704

    Skokie, Illinois, 60077

  • Site Reference ID/Investigator# 6717

    Snellville, Georgia, 30078

  • Site Reference ID/Investigator# 7016

    South Miami, Florida, 33143

  • Site Reference ID/Investigator# 7519

    Spokane, Washington, 99204

  • Site Reference ID/Investigator# 7890

    St Louis, Missouri, 63110

  • Site Reference ID/Investigator# 6709

    St Louis, Missouri, 63117

  • Site Reference ID/Investigator# 7018

    Stoney Brook, New York, 11790

  • Site Reference ID/Investigator# 8139

    Torrance, California, 90503

  • Site Reference ID/Investigator# 6584

    Tucson, Arizona, 85710

  • Site Reference ID/Investigator# 6912

    Tyler, Texas, 75703

  • Site Reference ID/Investigator# 7167

    Vallejo, California, 94589

  • Site Reference ID/Investigator# 7306

    Webster, Texas, 77598

  • Site Reference ID/Investigator# 7292

    West Dundee, Illinois, 60118

  • Site Reference ID/Investigator# 6590

    West Palm Beach, Florida, 33407

  • Site Reference ID/Investigator# 7293

    Wilmington, North Carolina, 28401

  • Site Reference ID/Investigator# 8251

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada23 sites

  • Site Reference ID/Investigator# 7314

    Barrie, L4M 6L2

  • Site Reference ID/Investigator# 7452

    Calgary, T3A 2N1

  • Site Reference ID/Investigator# 6702

    Edmonton, T5K 1X3

  • Site Reference ID/Investigator# 6716

    Halifax, B3H 0A2

  • Site Reference ID/Investigator# 7309

    Hamilton, L8N 1V6

  • Site Reference ID/Investigator# 6588

    Laval, H7S 2C6

  • Site Reference ID/Investigator# 6715

    London, N5X 2P1

  • Site Reference ID/Investigator# 7315

    London, N6A 3H7

  • Site Reference ID/Investigator# 7636

    Markham, L3P 1A8

  • Site Reference ID/Investigator# 6699

    Montreal, H2K 4L5

  • Site Reference ID/Investigator# 7316

    Montreal, H3H 1V4

  • Site Reference ID/Investigator# 7088

    North Bay, P1B 3Z7

  • Site Reference ID/Investigator# 7310

    Ottawa, K2G 6E2

  • Site Reference ID/Investigator# 7311

    Québec, G1V 4X7

  • Site Reference ID/Investigator# 7313

    St. John's, A1A 5E8

  • Site Reference ID/Investigator# 7317

    Surrey, V3R 6A7

  • Site Reference ID/Investigator# 7308

    Vancouver, V5Z 3Y1

  • Site Reference ID/Investigator# 6713

    Vancouver, V5Z 4E8

  • Site Reference ID/Investigator# 7067

    Waterloo, N2J 1C4

  • Site Reference ID/Investigator# 7312

    Westmount, H3Z 2S6

  • Site Reference ID/Investigator# 7087

    Windsor, N8W 1E6

  • Site Reference ID/Investigator# 6805

    Windsor, N8W 5L7

  • Site Reference ID/Investigator# 7638

    Winnipeg, R3C 1R4

Other trials in Canada

About this 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

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.

Being tested
Placebo, ABT-874
Keywords
Plaque Psoriasis

What participants receive

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

  • PlaceboDrug

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

  • ABT-874Biological

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

  • ABT-874Biological

    100mg every 12 weeks.

Study groups in NCT00570986
Study groupRoleWhat they receive
1Placebo comparatorArm #1 is used for entire study. At week 12, arm is rerandomized.
Receives: Drug: Placebo
2Active comparatorArm #2 is used for entire study. At week 12, arm is rerandomized.
Receives: Biological: ABT-874
3Active comparatorArm #3 is not used for weeks 0-11. At week 12, arm is rerandomized.
Receives: Biological: ABT-874

What is being measured

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

  1. PGA

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

  2. PASI

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

  3. PGA

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

Secondary outcomes (4)

  1. DLQI

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

  2. NAPSI

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

  3. PASI

    Measured: Subjects who achieve PASI 90 and 100 at Week 12

  4. Safety parameters

    Measured: Throughout study

Timeline

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

  1. First posted11 Dec 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJun 2009
  4. Study completionJun 2009

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,465 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00570986
Sponsor's protocol ID
M06-890
Status last verified
Jan 2013
First submitted
7 Dec 2007
Last updated
8 Feb 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABT-874 in people with Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 116 sites in 2 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 3 inclusion and 6 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 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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?

PGA (time frame: Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12). The study lists 3 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 NCT00570986.

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 8 Feb 2013.

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