P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses

Detailed Description
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.The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

Official Title
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A 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: AMAGINE-2

Conditions
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Moderate to Severe Plaque Psoriasis

Intervention / Treatment
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* Drug: 210 mg brodalumab
* Drug: 140 mg brodalumab
* Drug: ustekinumab
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has had stable moderate to severe plaque psoriasis for at least 6 months Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline Exclusion Criteria: Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations Subject has known history of Crohn's disease Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol Subject has not stopped using certain psoriasis therapies as defined in the study protocol Subject has previously used ustekinumab or any anti-IL-17 biologic therapy Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 210 mg brodalumab<br>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. | Drug: 210 mg brodalumab<br>* 210 mg brodalumab administered SC<br>|
| Experimental: 140 mg brodalumab<br>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. | Drug: 140 mg brodalumab<br>* 140 mg brodalumab administered SC<br>|
| Active Comparator: ustekinumab<br>Administered by subcutaneous (SC) injection per the labeled dosing regimen. | Drug: ustekinumab<br>* 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.<br>|
| Placebo Comparator: Placebo<br>Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab. | Drug: 210 mg brodalumab<br>* 210 mg brodalumab administered SC<br>Drug: placebo<br>* Placebo administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear). | 12 weeks | 
| Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 | to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12. | 12 weeks | 
| Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 | to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12. | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, brodalumab, AMG 827