Moderate and Severe Plaque PsoriasisPhase 2NCT00885196
A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis
A Phase 2 study testing AEB071 in people with Moderate and Severe Plaque Psoriasis, run by Novartis Pharmaceuticals at 40 sites in 9 countries.
Trial summary
This study is designed to provide efficacy and safety data of several doses of AEB071 so that the optimal dose and treatment duration can be chosen for testing in later studies in patients with plaque psoriasis (with a disease severity such that systemic treatment is justified). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate and Severe Plaque Psoriasis
- What is being tested?
- AEB071
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 40 sitesin 9 countries
- Study dates
- Apr 2009to Aug 2011
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate and Severe Plaque psoriasis diagnosed for at least 12 months (with or without psoriatic arthritis as comorbidity)that requires systemic therapy
- Severity of disease meeting all of the following three criteria:
- PASI score of 10 or greater
- Total Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater
- Investigator's Global Assessment (IGA) score of 3 or greater
Who cannot join
- Hematological abnormalities
- Heart rate < 50 or > 90 bpm when resting for 5 minutes
- Family history of long QT syndrome
- History of tachyarrhythmia
- History of conduction abnormality i.e., PR > 200 msec, 2nd or 3rd degree AV block, complete left or right branch bundle block, pre-excitation syndrome
- Uncontrolled or unstable angina pectoris; history of myocardial infarction within the previous 12 months
Show all 14Show fewer
- Known history of congestive heart failure
- History of percutaneous coronary intervention (PCI) or cardiac ablation
- History of stroke or transient ischemic attack (TIA)
- Implanted cardiac pacemaker or defibrillator
- History of malignancy of any organ system
- Current guttate, generalized erythrodermic, or pustular psoriasis
- Current drug associated psoriasis
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
40 sites in 9 countries.
40 sites in 9 countries
United States10 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Palmetto Clinical Trial Services
Greenville, South Carolina, 29607
Burke Pharmaceutical Research
Hot Springs, Arizona, 71913
Center for Clinical Studies
Houston, Texas, 77030
Suzanne Bruce & Associates, PA
Houston, Texas, 77056
Dermatology Specialists
Louisville, Kentucky, 40202
Virginia Clinical Research
Norfolk, Virginia, 23507
Kansas City Dermatology, PA
Overland Park, Kansas, 66215
Belleair Research Center, LLC
Pinellas Park, Florida, 33781
Central Dermatology
St Louis, Missouri, 63117
Germany8 sites
Novartis Investigative site
Berlin
Novartis Investigative site
Bonn
Novartis Investigative site
Erlangen
Novartis Investigative site
Frankfurt
Novartis Investigative site
Hamburg
Novartis Investigative site
Kiel
Novartis Investigative site
Leipzig
Novartis Investigative site
Regensburg
Italy5 sites
Novartis Investigative site
Milan
Novartis Investigative Site
Modena
Novartis Investigative Site
Rome
Novartis Investigative Site
Siena
Novartis Investigative Site
Verona
Australia4 sites
Novartis Investigative site
Benowa
Novartis Investigative site
Carlton
Novartis Investigative site
Kogarah
Novartis Investigative site
Parkville
Turkey (Türkiye)4 sites
Novartis Investigative Site
Ankara
Novartis Investigative Site
Gaziantep
Novartis Investigative Site
Izmir
Novartis Investigative Site
Manisa
Belgium3 sites
Novartis Investigative site
Brussels
Novartis Investigative site
Edegem
Novartis Investigative site
Liège
United Kingdom3 sites
Novartis Investigative site
Nuneaton
Novartis Investigative site
Salford
Novartis Investigative site
Southampton
Argentina2 sites
Novartis Investigative site
Buenos Aires
Novartis Investigative site
Mendoza
About this study
Official title: A Double Blind, Randomized, Placebo Controlled, Multicenter, Dose Finding Study of Oral AEB071 Assessing Psoriasis Area and Severity Index (PASI) Response and a Function of Dose and Treatment Duration (Primary Outcome) in Patients With Plaque Psoriasis
This study is designed to provide efficacy and safety data of several doses of AEB071 so that the optimal dose and treatment duration can be chosen for testing in later studies in patients with plaque psoriasis (with a disease severity such that systemic treatment is justified). The treatment free Follow-up Period is designed to provide additional safety data and information on disease recurrence after the last dose of the study drug.
- Conditions
- Moderate and Severe Plaque Psoriasis
- Being tested
- Placebo, AEB071
- Keywords
- Psoriasis, plaque psoriasis, inflammatory skin disease, scaly patches, AEB071
- Medical subject headings
- Lymphoma, Follicular, Psoriasis, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
AEB071Drug
| Study group | Role | What they receive |
|---|---|---|
| AEB071 200 mg BID | Experimental | Not described Receives: Drug: AEB071 |
| AEB071 400 mg OD | Experimental | Not described Receives: Drug: AEB071 |
| AEB071 300 mg BID | Experimental | Not described Receives: Drug: AEB071 |
| Placebo BID | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in plaque psoriasis as assessed by PASI response or PASI 75 (a patient that has an improvement from baseline PASI of at least 75%)
Measured: to 12 weeks treatment
Secondary outcomes (3)
ECG and laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs
Measured: up to 12 weeks treatment
change in PASI and Investigator's Global Assessment (IGA) of psoriasis in patients receiving AEB071 compared with placebo
Measured: up to 12 weeks treatment
disease recurrence (PASI, IGA) and the effect of treatment withdrawal (including AEs) in the treatment-free Follow-up Period
Measured: in the treatment-free Follow-up Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate and Severe Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885196
- Sponsor's protocol ID
- CAEB071C2201
- Other IDs
- EUDRACT number: 2007-007160-19
- Status last verified
- Apr 2016
- First submitted
- 20 Apr 2009
- Last updated
- 22 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo Controlled, Multicenter, Dose Finding Study of Oral AEB071 Assessing Psoriasis Area and Severity Index (PASI) Response and a Function of Dose and Treatment Duration (Primary Outcome) in Patients With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00885196
- Acronym / sponsor ID
- CAEB071C2201
- Conditions
- Moderate and Severe Plaque Psoriasis
- Keywords
- Psoriasis, plaque psoriasis, inflammatory skin disease, scaly patches, AEB071
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2011 (actual)
- First posted
- 21 Apr 2009 (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.
This study is designed to provide efficacy and safety data of several doses of AEB071 so that the optimal dose and treatment duration can be chosen for testing in later studies in patients with plaque psoriasis (with a disease severity such that systemic treatment is justified). The treatment free Follow-up Period is designed to provide additional safety data and information on disease recurrence after the last dose of the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AEB071 200 mg BID | Experimental | Drug: AEB071 |
| AEB071 400 mg OD | Experimental | Drug: AEB071 |
| AEB071 300 mg BID | Experimental | Drug: AEB071 |
| Placebo BID | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Moderate and Severe Plaque psoriasis diagnosed for at least 12 months (with or without psoriatic arthritis as comorbidity)that requires systemic therapy
- Severity of disease meeting all of the following three criteria:
Key exclusion criteria (14 listed)
- Hematological abnormalities
- Heart rate < 50 or > 90 bpm when resting for 5 minutes
- Family history of long QT syndrome
- History of tachyarrhythmia
- History of conduction abnormality i.e., PR > 200 msec, 2nd or 3rd degree AV block, complete left or right branch bundle block, pre-excitation syndrome
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 |
|---|---|---|
| Placebo | Drug | Placebo BID |
| AEB071 | Drug | AEB071 200 mg BID, AEB071 300 mg BID, AEB071 400 mg OD |
Primary outcome
Change from baseline in plaque psoriasis as assessed by PASI response or PASI 75 (a patient that has an improvement from baseline PASI of at least 75%)
Time frame: to 12 weeks treatment
3 secondary outcomes
ECG and laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs
Time frame: up to 12 weeks treatment
change in PASI and Investigator's Global Assessment (IGA) of psoriasis in patients receiving AEB071 compared with placebo
Time frame: up to 12 weeks treatment
disease recurrence (PASI, IGA) and the effect of treatment withdrawal (including AEs) in the treatment-free Follow-up Period
Time frame: in the treatment-free Follow-up Period
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 22 Dec 2020.
- Results for CAEB071C2201 from the Novartis Clinical Trials Results WebsiteLink provided by the sponsor.
Related trials for Moderate and Severe Plaque Psoriasis
RecruitingPhase 2
An Open-label Study of HS-20137 in Participants With Moderate-to-Severe Plaque Psoriasis
Moderate-to-severe Plaque Psoriasis
RecruitingPhase 3
Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis
Moderate-to-severe Chronic Plaque Psoriasis
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
Moderate to Severe Plaque Psoriasis
RecruitingPhase 1
A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis
Not yet recruitingPhase 2
A Phase 2 Study of HS-20118 to Evaluate the Efficacy and Safety in Participant With Moderate-to-Severe Plaque Psoriasis
Moderate to Severe 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
40 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AEB071 in people with Moderate and Severe Plaque Psoriasis, run by Novartis Pharmaceuticals at 40 sites in 9 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 5 inclusion and 14 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Germany, Italy, Australia, Turkey (Türkiye) and 4 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. 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?
Change from baseline in plaque psoriasis as assessed by PASI response or PASI 75 (a patient that has an improvement from baseline PASI of at least 75%) (time frame: to 12 weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2020.