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Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects
AMAGINE-1
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
2 other identifiers
interventional
661
6 countries
78
Brief Summary
The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2012
Typical duration for phase_3
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 10, 2012
CompletedFirst Posted
Study publicly available on registry
October 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
January 3, 2020
CompletedJanuary 3, 2020
December 1, 2019
1.7 years
September 10, 2012
November 2, 2016
December 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52
Week 0 - Week 52
Study Arms (3)
210 mg brodalumab
EXPERIMENTALAdministered 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.
140 mg brodalumab
EXPERIMENTALAdministered 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
PLACEBO COMPARATORAdministered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.
Interventions
210 mg brodalumab administered subcutaneous (SC)
140 mg brodalumab administered subcutaneous (SC)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Research Site
Phoenix, Arizona, 85023, United States
Research Site
Bakersfield, California, 93301, United States
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Encino, California, 91436, United States
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Los Angeles, California, 90045, United States
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San Diego, California, 92123, United States
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San Francisco, California, 94118, United States
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San Ramon, California, 94583, United States
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Santa Monica, California, 90404, United States
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Alpharetta, Georgia, 30022, United States
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West Dundee, Illinois, 60118, United States
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Richmond, Kentucky, 40475, United States
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Columbia, Maryland, 21045, United States
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Boston, Massachusetts, 02111, United States
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Fort Gratiot, Michigan, 48059, United States
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St Louis, Missouri, 63104, United States
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St Louis, Missouri, 63117, United States
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St Louis, Missouri, 63141, United States
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Omaha, Nebraska, 68131, United States
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Buffalo, New York, 14221, United States
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Forest Hills, New York, 11375, United States
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Rochester, New York, 14618, United States
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Stony Brook, New York, 11790, United States
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Wilmington, North Carolina, 28401, United States
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Cleveland, Ohio, 44106, United States
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Portland, Oregon, 97223, United States
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Rapid City, South Dakota, 57702, United States
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Goodlettsville, Tennessee, 37072, United States
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Nashville, Tennessee, 37215, United States
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Arlington, Texas, 76011, United States
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Austin, Texas, 78759, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78229, United States
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Surrey, British Columbia, V3R 6A7, Canada
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Moncton, New Brunswick, E1C 8X3, Canada
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Halifax, Nova Scotia, B3H 0A2, Canada
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Greater Sudbury, Ontario, P3C 1X8, Canada
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London, Ontario, N6A 3H7, Canada
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North Bay, Ontario, P1B 3Z7, Canada
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Waterloo, Ontario, N2J 1C4, Canada
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Windsor, Ontario, N8W 1E6, Canada
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Montreal, Quebec, H2K 4L5, Canada
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Québec, Quebec, G1V 4X7, Canada
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Nice, 06200, France
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Pessac, 33604, France
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Saint-Priest-en-Jarez, 42270, France
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Toulouse, 31059, France
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Berlin, 10117, Germany
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Berlin, 13507, Germany
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Blankenfelde, 15831, Germany
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Bochum, 44803, Germany
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Bonn, 53105, Germany
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Buchholz, 21244, Germany
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Dülmen, 48249, Germany
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Frankfurt am Main, 60590, Germany
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Friedrichshafen, 88045, Germany
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Halle, 06120, Germany
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Hamburg, 20246, Germany
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Hamburg, 20354, Germany
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Kiel, 24105, Germany
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Münster, 48149, Germany
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Osnabrück, 49074, Germany
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Iwonicz-Zdrój, 38-440, Poland
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Lodz, 90-265, Poland
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Lodz, 90-436, Poland
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Olsztyn, 10-228, Poland
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Poznan, 60-539, Poland
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Szczecin, 70-111, Poland
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Torun, 87-100, Poland
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Warsaw, 01-192, Poland
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Wroclaw, 50-088, Poland
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Wroclaw, 50-368, Poland
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Wroclaw, 51-318, Poland
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Basel, 4031, Switzerland
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Bern, 3010, Switzerland
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Geneva, 1211, Switzerland
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Lausanne, 1011, Switzerland
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Zurich, 8091, Switzerland
Related Publications (1)
Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.
PMID: 32207067DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2012
First Posted
October 17, 2012
Study Start
August 1, 2012
Primary Completion
May 1, 2014
Study Completion
August 1, 2015
Last Updated
January 3, 2020
Results First Posted
January 3, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share