PsoriasisPhase 2NCT00292396
Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
A Phase 2 study testing Anti IL-12 monoclonal antibody/ABT-874 in people with Psoriasis, run by AbbVie (prior sponsor, Abbott) at 24 sites in 2 countries.
Trial summary
The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Anti IL-12 monoclonal antibody/ABT-874
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Nov 2005to Apr 2008
- Phase
- Phase 2
- 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 was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
- Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
Who cannot join
- Subject had previously received systemic or biologic 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 injectable corticosteroids
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States16 sites
Site Reference ID/Investigator# 3347
Alpharetta, Georgia, 30022
Site Reference ID/Investigator# 990
Boston, Massachusetts, 02114
Site Reference ID/Investigator# 992
Cincinnati, Ohio, 45219
Site Reference ID/Investigator# 3350
Dallas, Texas, 75246-1613
Site Reference ID/Investigator# 796
Houston, Texas, 77030
Site Reference ID/Investigator# 993
Indianapolis, Indiana, 46256
Site Reference ID/Investigator# 3346
Johnston, Rhode Island, 02919
Site Reference ID/Investigator# 991
Lake Oswego, Oregon, 97035
Site Reference ID/Investigator# 994
Nashville, Tennessee, 37215
Site Reference ID/Investigator# 3366
Norfolk, Virginia, 23507
Site Reference ID/Investigator# 3367
Portland, Oregon, 97223
Site Reference ID/Investigator# 2081
Salt Lake City, Utah, 84132
Site Reference ID/Investigator# 3351
San Diego, California, 92123
Site Reference ID/Investigator# 989
Seattle, Washington, 98101
Site Reference ID/Investigator# 3348
Skokie, Illinois, 60077
Site Reference ID/Investigator# 3349
St Louis, Missouri, 63117
Canada8 sites
Site Reference ID/Investigator# 3361
Halifax, B3H 1Z4
Site Reference ID/Investigator# 985
Laval, H7S 2C6
Site Reference ID/Investigator# 987
London, N5X 2P1
Site Reference ID/Investigator# 3364
Montreal, H2K 4L5
Site Reference ID/Investigator# 794
North Bay, P1B 3Z7
Site Reference ID/Investigator# 988
Québec, G1V 4X7
Site Reference ID/Investigator# 795
Waterloo, N2J 1C4
Site Reference ID/Investigator# 3360
Windsor, N8W 1E6
About this study
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Subcutaneous Injections of ABT-874 vs. Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis.
- Conditions
- Psoriasis
- Being tested
- Anti IL-12 monoclonal antibody/ABT-874, placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti IL-12 monoclonal antibody/ABT-874Drug
Please see Arm Description for intervention description and details.
placeboDrug
12 doses
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks Receives: Drug: Anti IL-12 monoclonal antibody/ABT-874 |
| 2 | Active comparator | Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks Receives: Drug: Anti IL-12 monoclonal antibody/ABT-874 |
| 3 | Active comparator | Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks Receives: Drug: Anti IL-12 monoclonal antibody/ABT-874 |
| 4 | Active comparator | Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks Receives: Drug: Anti IL-12 monoclonal antibody/ABT-874 |
| 5 | Active comparator | Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks Receives: Drug: Anti IL-12 monoclonal antibody/ABT-874 |
| 6 | Placebo comparator | placebo, 12 doses Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with clinical response relative to Baseline PASI score
Measured: Week 12, Week 40 and Week 60
Secondary outcomes (4)
Quality of Life Surveys
Measured: Week 12, Week 48 and Week 60
Clinical response indicators
Measured: Week 12, Week 48 and Week 60
Safety parameters
Measured: Monthly through duration of study
PGA Assessment
Measured: Week 12, Week 40 and Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startNov 2005
- Primary completionApr 2008
- Study completionApr 2008
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Kaul, MD, Study chair, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292396
- Sponsor's protocol ID
- M05-736
- Status last verified
- Jan 2013
- First submitted
- 14 Feb 2006
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kimball AB, Gordon KB, Langley RG, Menter A, Chartash EK, Valdes J; ABT-874 Psoriasis Study Investigators. Safety and efficacy of ABT-874, a fully human interleukin 12/23 monoclonal antibody, in the treatment of moderate to severe chronic plaque psoriasis: results of a randomized, placebo-controlled, phase 2 trial. Arch Dermatol. 2008 Feb;144(2):200-7. doi: 10.1001/archdermatol.2007.63.
PubMed 18283176
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 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Subcutaneous Injections of ABT-874 vs. Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00292396
- Acronym / sponsor ID
- M05-736
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 16 Feb 2006 (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.
The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Anti IL-12 monoclonal antibody/ABT-874Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks |
| 2 | Active comparator | Drug: Anti IL-12 monoclonal antibody/ABT-874Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks |
| 3 | Active comparator | Drug: Anti IL-12 monoclonal antibody/ABT-874Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks |
| 4 | Active comparator | Drug: Anti IL-12 monoclonal antibody/ABT-874Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks |
| 5 | Active comparator | Drug: Anti IL-12 monoclonal antibody/ABT-874Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks |
| 6 | Placebo comparator | Drug: placeboplacebo, 12 doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
- Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
Key exclusion criteria (5 listed)
- Subject had previously received systemic or biologic 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 injectable corticosteroids
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
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 |
|---|---|---|
| Anti IL-12 monoclonal antibody/ABT-874Please see Arm Description for intervention description and details. | Drug | 1, 2, 3, 4, 5 |
| placebo12 doses | Drug | 6 |
Primary outcome
Proportion of subjects with clinical response relative to Baseline PASI score
Time frame: Week 12, Week 40 and Week 60
4 secondary outcomes
Quality of Life Surveys
Time frame: Week 12, Week 48 and Week 60
Clinical response indicators
Time frame: Week 12, Week 48 and Week 60
Safety parameters
Time frame: Monthly through duration of study
PGA Assessment
Time frame: Week 12, Week 40 and Week 60
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 18283176Kimball AB, Gordon KB, Langley RG, Menter A, Chartash EK, Valdes J; ABT-874 Psoriasis Study Investigators. Safety and efficacy of ABT-874, a fully human interleukin 12/23 monoclonal antibody, in the treatment of moderate to severe chronic plaque psoriasis: results of a randomized, placebo-controlled, phase 2 trial. Arch Dermatol. 2008 Feb;144(2):200-7. doi: 10.1001/archdermatol.2007.63.
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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 chair
AbbVie
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti IL-12 monoclonal antibody/ABT-874 in people with Psoriasis, run by AbbVie (prior sponsor, Abbott) at 24 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 2 inclusion and 5 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 24 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 with clinical response relative to Baseline PASI score (time frame: Week 12, Week 40 and Week 60). 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 NCT00292396, 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.