PsoriasisPhase 3AMAGINE-3NCT02786732
Study to Evaluate Broadlumab vs Placebo and Ustekinumab
A Phase 3 study testing 210mg Brodalumab, 140mg Brodalumab and Ustekinumab in people with Psoriasis, run by MedDerm Associates at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of Induction and Maintenance Regimens of Brodalumab compared with Placebo and Ustekinumab in subjects with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- 210mg Brodalumab, 140mg Brodalumab and Ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Oct 2017
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has had stable moderate to severe plaque psoriasis for at least 6 months before first dose of IP.
- Subject has involved body surface area >_10%, PASI>_, and sPGA>_3 at screening and at baseline.
- For women, a negative serum pregnancy test during screening a negative urine pregnancy test at baseline.
- Subject has no known history of active tuberculosis.
- Subject has a negative test for tuberculosis during screening.
Who cannot join
- Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit that would interfere with evaluations of the effect of IP on psoriasis.
- Subject has a planned surgical intervention between baseline and the week 52 evaluation.
- Subject an active infection or history of infections.
- Subject has any systemic disease considered by the investigator to be clinically significant and uncontrolled.
- Subject has known history of Crohn's disease.
- Subject has known history of hepatitis B, hepatitis C, or human immunodeficiency virus.
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- Subject had myocardial infarction or unstable angina pectoris within the past 12 months prior to the first dose of IP.
- Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
- Subject has history of malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma.
- Subject has received live vaccine(s) within 28 days of the first dose of IP.
- Subject has used ustekinumab and/or antio-IL-17 biologic therapy ever or other experimental or commercially available biologi immune modulator(s) within 12weeks prior to the first IP dose
- Subject currently is enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s).
- For women not willing to use highly effective methods of birth control during treatment and for 15 weeks after the last dose.
- For women; pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 15 weeks after the last dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
The purpose of the study is to evaluate the efficacy and safety of Induction and Maintenance Regimens of Brodalumab compared with Placebo and Ustekinumab in subjects with moderate to severe plaque psoriasis.
Read the detailed description
The study is up to 5 years. If you qualify, you will be randomized into 1 of 4 groups. Two groups will get brodalumab(1 group will get 210milligrams of brodalumab at each dose and the other group will get 140 milligrams of brodalumab at each dose), one group will get ustekinumab, and one group will get placebo.
- Conditions
- Psoriasis
- Being tested
- 210mg Brodalumab, 140mg Brodalumab, Ustekinumab, Placebo
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
210mg BrodalumabBiological
Brodalumab 210mg administered subcutaneously
140mg BrodalumabBiological
Brodalumab 140mg administered subcutaneously
UstekinumabBiological
Ustekinumab 45mg or 90mg adminstered subcutaneously
PlaceboBiological
Placebo administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| 210mg Brodalumab | Experimental | Administered by subcutaneous injection until Week 12 Receives: Biological: 210mg Brodalumab |
| 140mg Brodalumab | Experimental | Administered subcutaneous injection until Week 12 Receives: Biological: 210mg Brodalumab |
| Ustekinumab | Active comparator | Administered subcutaneous injection until Week 52 Receives: Biological: 140mg Brodalumab |
| Placebo | Placebo comparator | Administered subcutaneous injection until Week 12 Receives: Biological: 210mg Brodalumab; Biological: Ustekinumab; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI Improvement
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 posted1 Jun 2016 (estimated)
- Study startAug 2012
- Primary completionJun 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedDerm Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Michelle Pelle, M.D., MedDerm Associates
- Investigators
- Michelle T Pelle, M.D., Principal investigator, MedDerm Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786732
- Sponsor's protocol ID
- 20120104
- Acronym
- AMAGINE-3
- Status last verified
- May 2016
- First submitted
- 23 Jun 2014
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02786732
- Acronym / sponsor ID
- AMAGINE-3 / 20120104
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor
- Enrolment
- 15 participants (actual)
- Lead sponsor
- MedDerm AssociatesIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 1 Jun 2016 (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 evaluate the efficacy and safety of Induction and Maintenance Regimens of Brodalumab compared with Placebo and Ustekinumab in subjects with moderate to severe plaque psoriasis.
Detailed description
The study is up to 5 years. If you qualify, you will be randomized into 1 of 4 groups. Two groups will get brodalumab(1 group will get 210milligrams of brodalumab at each dose and the other group will get 140 milligrams of brodalumab at each dose), one group will get ustekinumab, and one group will get placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 210mg Brodalumab | Experimental | Biological: 210mg BrodalumabAdministered by subcutaneous injection until Week 12 |
| 140mg Brodalumab | Experimental | Biological: 210mg BrodalumabAdministered subcutaneous injection until Week 12 |
| Ustekinumab | Active comparator | Biological: 140mg BrodalumabAdministered subcutaneous injection until Week 52 |
| Placebo | Placebo comparator | Biological: 210mg Brodalumab, Biological: Ustekinumab, Biological: PlaceboAdministered subcutaneous injection until Week 12 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has had stable moderate to severe plaque psoriasis for at least 6 months before first dose of IP.
- Subject has involved body surface area >_10%, PASI>_, and sPGA>_3 at screening and at baseline.
- For women, a negative serum pregnancy test during screening a negative urine pregnancy test at baseline.
- Subject has no known history of active tuberculosis.
- Subject has a negative test for tuberculosis during screening.
Key exclusion criteria (14 listed)
- Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit that would interfere with evaluations of the effect of IP on psoriasis.
- Subject has a planned surgical intervention between baseline and the week 52 evaluation.
- Subject an active infection or history of infections.
- Subject has any systemic disease considered by the investigator to be clinically significant and uncontrolled.
- Subject has known history of Crohn's disease.
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 |
|---|---|---|
| 210mg BrodalumabBrodalumab 210mg administered subcutaneously | Biological | 140mg Brodalumab, 210mg Brodalumab, Placebo |
| 140mg BrodalumabBrodalumab 140mg administered subcutaneously | Biological | Ustekinumab |
| UstekinumabUstekinumab 45mg or 90mg adminstered subcutaneously | Biological | Placebo |
| PlaceboPlacebo administered subcutaneously | Biological | Placebo |
Primary outcome
PASI Improvement
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Michelle T Pelle, M.D. principal investigator
MedDerm Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 210mg Brodalumab, 140mg Brodalumab and Ustekinumab in people with Psoriasis, run by MedDerm Associates at 1 site 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 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: stopped early, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Sponsor). Results are not available in the source record.
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?
PASI Improvement (time frame: 12 weeks). 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 1 Jun 2016.