Moderate to Severe Plaque PsoriasisPhase 3NCT00710580
Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
A Phase 3 study testing ABT-874 and etanercept in people with Moderate to Severe Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 42 sites in United States.
Trial summary
Compare the efficacy of ABT-874 versus etanercept in 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
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- ABT-874 and etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 42 sitesUnited States
- Study dates
- Jul 2008to Apr 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
- Diagnosis of Psoriasis for 6 MO
- BSA 10%
- PASI 12 or above
- PGA 3 or above
Who cannot join
- Previous exposure to either etanercept or ABT-874
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Site Reference ID/Investigator# 15201
Alpharetta, Georgia, 30022
Site Reference ID/Investigator# 10762
Atlanta, Georgia, 30327
Site Reference ID/Investigator# 9985
Bakersfield, California, 93309
Site Reference ID/Investigator# 9786
Berlin, New Jersey, 08009
Site Reference ID/Investigator# 9984
Birmingham, Alabama, 35205
Site Reference ID/Investigator# 10605
Birmingham, Alabama, 35233
Site Reference ID/Investigator# 9981
Dallas, Texas, 75230
Site Reference ID/Investigator# 10504
Dayton, Ohio, 45408
Site Reference ID/Investigator# 9788
Fort Gratiot, Michigan, 48059
Site Reference ID/Investigator# 10541
Fridley, Minnesota, 55432
Site Reference ID/Investigator# 10604
Grand Blanc, Michigan, 48439
Site Reference ID/Investigator# 9902
Hickory, North Carolina, 28601
Site Reference ID/Investigator# 10661
Irvine, California, 92697
Site Reference ID/Investigator# 10503
Jacksonville, Florida, 32204
Site Reference ID/Investigator# 10643
Knoxville, Tennessee, 37934
Site Reference ID/Investigator# 10502
Little Rock, Arkansas, 72205
Site Reference ID/Investigator# 14701
Los Angeles, California, 90045
Site Reference ID/Investigator# 10265
Louisville, Kentucky, 40202
Site Reference ID/Investigator# 10666
Maywood, Illinois, 60153
Site Reference ID/Investigator# 10266
Miami, Florida, 33144
Site Reference ID/Investigator# 9901
Miami, Florida, 33173
Site Reference ID/Investigator# 10321
Milwaukee, Wisconsin, 53209
Site Reference ID/Investigator# 10263
New Haven, Connecticut, 06511
Site Reference ID/Investigator# 10241
New York, New York, 10016
Site Reference ID/Investigator# 10262
Newnan, Georgia, 30263
Site Reference ID/Investigator# 10606
Omaha, Nebraska, 68131
Site Reference ID/Investigator# 10644
Omaha, Nebraska, 68144
Site Reference ID/Investigator# 15750
Owensboro, Kentucky, 42303
Site Reference ID/Investigator# 9790
Owensboro, Kentucky, 42303
Site Reference ID/Investigator# 15142
Plainfield, Indiana, 46168
Site Reference ID/Investigator# 9787
Rochester, New York, 14623
Site Reference ID/Investigator# 10264
San Antonio, Texas, 78229
Site Reference ID/Investigator# 9785
San Diego, California, 92123
Site Reference ID/Investigator# 10662
Santa Monica, California, 90404
Site Reference ID/Investigator# 10001
Scottsdale, Arizona, 85251
Site Reference ID/Investigator# 10182
Seattle, Washington, 98101
Site Reference ID/Investigator# 9789
Snellville, Georgia, 30078
Site Reference ID/Investigator# 10641
St Louis, Missouri, 63110
Site Reference ID/Investigator# 10642
Vallejo, California, 94589
Site Reference ID/Investigator# 9982
Webster, Texas, 77598
Site Reference ID/Investigator# 10501
West Palm Beach, Florida, 33407
Site Reference ID/Investigator# 10581
Wilmington, North Carolina, 28401
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- ABT-874, etanercept, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-874Biological
SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8
etanerceptBiological
SQ injection 50 mg BIW
placeboDrug
SQ placebo injections for ABT-874 and etanercept
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Biological: ABT-874 |
| B | Active comparator | Not described Receives: Biological: etanercept |
| C | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12
Measured: 12 Weeks
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12
Measured: 12 Weeks
Secondary outcomes (1)
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Paragon Biomedical
- Responsible party
- Sponsor
- Investigators
- Martin Kaul, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710580
- Sponsor's protocol ID
- M10-315
- Status last verified
- Jan 2013
- First submitted
- 2 Jul 2008
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Strober BE, Crowley JJ, Yamauchi PS, Olds M, Williams DA. Efficacy and safety results from a phase III, randomized controlled trial comparing the safety and efficacy of briakinumab with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis. Br J Dermatol. 2011 Sep;165(3):661-8. doi: 10.1111/j.1365-2133.2011.10419.x. Epub 2011 Jul 28.
PubMed 21574984
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00710580
- Acronym / sponsor ID
- M10-315
- Conditions
- Moderate to Severe Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Paragon Biomedical
- Study start
- Jul 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 4 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: ABT-874 |
| B | Active comparator | Biological: etanercept |
| C | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Psoriasis for 6 MO
- BSA 10%
- PASI 12 or above
- PGA 3 or above
Key exclusion criteria (1 listed)
- Previous exposure to either etanercept or ABT-874
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-874SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8 | Biological | A |
| etanerceptSQ injection 50 mg BIW | Biological | B |
| placeboSQ placebo injections for ABT-874 and etanercept | Drug | C |
Primary outcome
Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12
Time frame: 12 Weeks
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12
Time frame: 12 Weeks
1 secondary outcome
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- Derived from this study: PubMed 21574984Strober BE, Crowley JJ, Yamauchi PS, Olds M, Williams DA. Efficacy and safety results from a phase III, randomized controlled trial comparing the safety and efficacy of briakinumab with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis. Br J Dermatol. 2011 Sep;165(3):661-8. doi: 10.1111/j.1365-2133.2011.10419.x. Epub 2011 Jul 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Kaul, MD study director
AbbVie
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ABT-874 and etanercept in people with Moderate to Severe Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 42 sites in United States.
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 4 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 18 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 42 sites in United States. 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?
Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (time frame: 12 Weeks). The study lists 2 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 NCT00710580, which also lists 1 linked publication.
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 18 Jan 2013; AzTrials last refreshed its copy on 7 Nov 2026.