P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis (AMAGINE-2)

Bausch Health

Status and phase: Terminated; Phase 3

Conditions: Moderate to Severe Plaque Psoriasis

Treatments: Drug: ustekinumab; Drug: 210 mg brodalumab; Drug: 140 mg brodalumab; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01708603

20120103

Details and patient eligibility

About

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

Full description

.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.

Enrollment: 1,831 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,831 participants in 4 patient groups, including a placebo group

210 mg brodalumab

Experimental group

Description:

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

Treatment:

Drug: 210 mg brodalumab

140 mg brodalumab

Experimental group

Description:

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

Treatment:

Drug: 140 mg brodalumab

ustekinumab

Active Comparator group

Description:

Administered by subcutaneous (SC) injection per the labeled dosing regimen.

Treatment:

Drug: ustekinumab

Placebo

Placebo Comparator group

Description:

Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

Treatment:

Drug: 210 mg brodalumab

Drug: placebo