Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-1)

Bausch Health

Status and phase: Terminated; Phase 3

Conditions: Psoriasis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01708590

2012-000651-13 (EudraCT Number)

20120102

Details and patient eligibility

About

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

Full description

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.

Enrollment: 661 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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661 participants in 3 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 placebo or continued treatment. Participants are retreated at return of disease.

Treatment:

Drug: 210 mg brodalumab

Drug: placebo

140 mg brodalumab

Experimental group

Description:

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.

Treatment:

Drug: placebo

Drug: 140 mg brodalumab

placebo

Placebo Comparator group

Description:

Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.

Treatment:

Drug: 210 mg brodalumab

Drug: placebo