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Sponsor
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 210mg Brodalumab | Experimental | Administered by subcutaneous injection until Week 12 |
|
| 140mg Brodalumab | Experimental | Administered subcutaneous injection until Week 12 |
|
| Ustekinumab | Active Comparator | Administered subcutaneous injection until Week 52 |
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| Placebo | Placebo Comparator | Administered subcutaneous injection until Week 12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 210mg Brodalumab | Biological | Brodalumab 210mg administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| PASI Improvement | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle T Pelle, M.D. | MedDerm Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedDerm Associates | San Diego | California | 92103 | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C571216 | brodalumab |
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 140mg Brodalumab | Biological | Brodalumab 140mg administered subcutaneously |
|
| Ustekinumab | Biological | Ustekinumab 45mg or 90mg adminstered subcutaneously |
|
| Placebo | Biological | Placebo administered subcutaneously |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |