Plaque PsoriasisPhase 3NCT00691964
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 Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 35 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
- 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
- 347 participants
- Where
- 35 sitesUnited States
- Study dates
- May 2008to Mar 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
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Site Reference ID/Investigator# 8447
Albuquerque, New Mexico, 87106
Site Reference ID/Investigator# 8463
Alpharetta, Georgia, 30022
Site Reference ID/Investigator# 8479
Arlington Heights, Illinois, 60005
Site Reference ID/Investigator# 8461
Austin, Texas, 78759
Site Reference ID/Investigator# 8464
Boston, Massachusetts, 02111
Site Reference ID/Investigator# 8468
Cincinnati, Ohio, 45219
Site Reference ID/Investigator# 8460
Cleveland, Ohio, 44106
Site Reference ID/Investigator# 10542
Dallas, Texas, 75246-1613
Site Reference ID/Investigator# 8476
Denver, Colorado, 80209
Site Reference ID/Investigator# 8473
East Windsor, New Jersey, 08520
Site Reference ID/Investigator# 8462
Fresno, California, 93720
Site Reference ID/Investigator# 8458
Goodlettsville, Tennessee, 37072
Site Reference ID/Investigator# 8456
Greer, South Carolina, 29651
Site Reference ID/Investigator# 9761
Hershey, Pennsylvania, 17033
Site Reference ID/Investigator# 8452
Houston, Texas, 77030
Site Reference ID/Investigator# 8467
Indianapolis, Indiana, 46256
Site Reference ID/Investigator# 8449
Johnston, Rhode Island, 02919
Site Reference ID/Investigator# 8480
Lake Oswego, Oregon, 97035
Site Reference ID/Investigator# 8454
Los Angeles, California, 90045
Site Reference ID/Investigator# 9641
Miami, Florida, 33136
Site Reference ID/Investigator# 8457
New Brunswick, New Jersey, 08903
Site Reference ID/Investigator# 8475
New York, New York, 10029-6501
Site Reference ID/Investigator# 8472
Norfolk, Virginia, 23507
Site Reference ID/Investigator# 9762
Oklahoma City, Oklahoma, 73104
Site Reference ID/Investigator# 8471
Philadelphia, Pennsylvania, 19103
Site Reference ID/Investigator# 8469
Portland, Oregon, 97210
Site Reference ID/Investigator# 9566
Portland, Oregon, 97223
Site Reference ID/Investigator# 8448
Providence, Rhode Island, 02903
Site Reference ID/Investigator# 8474
San Antonio, Texas, 78229
Site Reference ID/Investigator# 8527
Schaumburg, Illinois, 60194
Site Reference ID/Investigator# 9001
Skokie, Illinois, 60077
Site Reference ID/Investigator# 8459
St Louis, Missouri, 63117
Site Reference ID/Investigator# 8478
Tucson, Arizona, 85710
Site Reference ID/Investigator# 8482
Tyler, Texas, 75703
Site Reference ID/Investigator# 8466
West Dundee, Illinois, 60118
About this study
Official title: A Phase 3, Multi-Center, 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
- 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 posted6 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionMar 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 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
- 347 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
- NCT00691964
- Sponsor's protocol ID
- M10-114
- Status last verified
- Jan 2013
- First submitted
- 4 Jun 2008
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gottlieb AB, Leonardi C, Kerdel F, Mehlis S, Olds M, Williams DA. Efficacy and safety of briakinumab vs. etanercept and placebo in patients with moderate to severe chronic plaque psoriasis. Br J Dermatol. 2011 Sep;165(3):652-60. doi: 10.1111/j.1365-2133.2011.10418.x. Epub 2011 Aug 4.
PubMed 21574983
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Center, 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
- NCT00691964
- Acronym / sponsor ID
- M10-114
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Paragon Biomedical
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Jun 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 (2 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 21 Jan 2013.
- Derived from this study: PubMed 21574983Gottlieb AB, Leonardi C, Kerdel F, Mehlis S, Olds M, Williams DA. Efficacy and safety of briakinumab vs. etanercept and placebo in patients with moderate to severe chronic plaque psoriasis. Br J Dermatol. 2011 Sep;165(3):652-60. doi: 10.1111/j.1365-2133.2011.10418.x. Epub 2011 Aug 4.
Related trials for Plaque Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
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
35 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 Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 35 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 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 21 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 35 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 NCT00691964, 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 21 Jan 2013.