Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects

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 taken every two weeks at two different doses.

Detailed Description
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The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy when brodalumab is replaced with placebo in some participants compared with the participants who are still receiving the brodalumab.

Official Title
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A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: 210 mg brodalumab
* Drug: 140 mg brodalumab
* 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 must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling 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 stopped using certain psoriasis therapies as defined in the study protocol Subject has previously used any anti-IL-17 biologic therapy

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 placebo or continued treatment. Participants are retreated at return of disease. | Drug: 210 mg brodalumab<br>* 210 mg brodalumab administered subcutaneous (SC)<br>* Other names: Siliq;Drug: placebo<br>* Placebo administered subcutaneous (SC)<br>|
| Experimental: 140 mg brodalumab<br>Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease. | Drug: 140 mg brodalumab<br>* 140 mg brodalumab administered subcutaneous (SC)<br>* Other names: Siliq;Drug: placebo<br>* Placebo administered subcutaneous (SC)<br>|
| Placebo Comparator: placebo<br>Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab. | Drug: 210 mg brodalumab<br>* 210 mg brodalumab administered subcutaneous (SC)<br>* Other names: Siliq;Drug: placebo<br>* Placebo administered subcutaneous (SC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 | to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12. | 0-12 weeks | 
| Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear [0] or almost clear [1]) on the static physicians global assessment (sPGA) at week 12 | 0 - 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52 | to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear[0] or almost clear [1]) at week 52. | Week 0 - Week 52 | 

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