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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2014

Detailed 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.

Interventions

  • Drug: 210 mg brodalumab
    • 210 mg brodalumab administered subcutaneous (SC)
  • Drug: 140 mg brodalumab
    • 140 mg brodalumab administered subcutaneous (SC)
  • Drug: placebo
    • Placebo administered subcutaneous (SC)

Arms, Groups and Cohorts

  • Experimental: 210 mg brodalumab
    • 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.
  • Experimental: 140 mg brodalumab
    • 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.
  • Placebo Comparator: placebo
    • Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12
    • Time Frame: 0-12 weeks
    • 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.
  • Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
    • Time Frame: 0 – 12 Weeks
    • 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

Secondary Measures

  • Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52
    • Time Frame: Week 0 – 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bausch Health Americas, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • MD, Study Director, Amgen

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