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-3
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Bausch Health Americas, Inc.
- Enrollment
- 1,881
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
Study Overview
Brief Summary
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.
Detailed Description
This study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
210 mg brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
Intervention: 210 mg brodalumab (Drug)
140 mg brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
Intervention: 140 mg brodalumab (Drug)
ustekinumab
Administered by subcutaneous (SC) injection per the labeled dosing regimen.
Intervention: ustekinumab (Drug)
Placebo
Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
Intervention: 210 mg brodalumab (Drug)
Placebo
Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
Time Frame: 12 weeks
The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed.
Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo
Time Frame: 12 weeks
Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 \[clear\] to 5 \[severe\]). Success was defined by a score of 0 or 1 (clear to almost clear).
Secondary Outcomes
No secondary outcomes reported