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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01708590
First received: September 10, 2012
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Moderate to Severe Plaque Psoriasis
Drug: 210 mg brodalumab
Drug: 140 mg brodalumab
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Static Physician Global Assessment (sPGA) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis

  • Improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis


Secondary Outcome Measures:
  • Static Physician Global Assessment (sPGA) score [ Time Frame: 12 weeks and 52 weeks ] [ Designated as safety issue: No ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis

  • Improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis

  • Patient reported outcomes. Symptom score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Subject-reported outcomes assessment

  • Subject incidence of adverse events [ Time Frame: 12 weeks and 5 years and 3 months ] [ Designated as safety issue: Yes ]
    Safety profile of brodalumab

  • Subject incidence of adverse events of interest [ Time Frame: 12 weeks and 5 years and 3 months ] [ Designated as safety issue: Yes ]
    Safety profile of brodalumab

  • Presence of anti-brodalumab antibodies [ Time Frame: 12 weeks and 5 years ] [ Designated as safety issue: Yes ]
    Safety profile of brodalumab


Enrollment: 661
Study Start Date: August 2012
Estimated Study Completion Date: September 2018
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 210 mg brodalumab
210 mg brodalumab administered subcutaneous (SC)
Drug: placebo
Placebo administered subcutaneous (SC)
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.
Drug: 140 mg brodalumab
140 mg brodalumab administered subcutaneous (SC)
Drug: placebo
Placebo administered subcutaneous (SC)
Placebo Comparator: placebo
Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.
Drug: 210 mg brodalumab
210 mg brodalumab administered subcutaneous (SC)
Drug: placebo
Placebo administered subcutaneous (SC)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708590

  Hide Study Locations
Locations
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85023
United States, California
Research Site
Bakersfield, California, United States, 93301
Research Site
Encino, California, United States, 91436
Research Site
Los Angeles, California, United States, 90045
Research Site
San Diego, California, United States, 92123
Research Site
San Francisco, California, United States, 94118
Research Site
San Ramon, California, United States, 94583
Research Site
Santa Monica, California, United States, 90404
United States, Georgia
Research Site
Alpharetta, Georgia, United States, 30022
United States, Illinois
Research Site
West Dundee, Illinois, United States, 60118
United States, Kentucky
Research Site
Richmond, Kentucky, United States, 40475
United States, Maryland
Research Site
Columbia, Maryland, United States, 21045
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02111
United States, Michigan
Research Site
Fort Gratiot, Michigan, United States, 48059
United States, Missouri
Research Site
St Louis, Missouri, United States, 63104
Research Site
St. Louis, Missouri, United States, 63117
Research Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68131
United States, New York
Research Site
Buffalo, New York, United States, 14221
Research Site
Forest Hills, New York, United States, 11375
Research Site
Rochester, New York, United States, 14618
Research Site
Stony Brook, New York, United States, 11790
United States, North Carolina
Research Site
Wilmington, North Carolina, United States, 28401
United States, Ohio
Research Site
Cleveland, Ohio, United States, 44106
United States, Oregon
Research Site
Portland, Oregon, United States, 97223
United States, South Dakota
Research Site
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Research Site
Goodlettsville, Tennessee, United States, 37072
Research Site
Nashville, Tennessee, United States, 37215
United States, Texas
Research Site
Arlington, Texas, United States, 76011
Research Site
Austin, Texas, United States, 78759
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Dallas, Texas, United States, 75231
Research Site
Houston, Texas, United States, 77030
Research Site
San Antonio, Texas, United States, 78229
Canada, British Columbia
Research Site
Surrey, British Columbia, Canada, V3R 6A7
Canada, New Brunswick
Research Site
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada, B3H 0A2
Canada, Ontario
Research Site
London, Ontario, Canada, N6A 3H7
Research Site
North Bay, Ontario, Canada, P1B 3Z7
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Sudbury, Ontario, Canada, P3C 1X8
Research Site
Waterloo, Ontario, Canada, N2J 1C4
Research Site
Windsor, Ontario, Canada, N8W 1E6
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H2K 4L5
Canada
Research Site
Quebec, Canada, G1V 4X7
France
Research Site
Nice, France, 06200
Research Site
Pessac Cedex, France, 33604
Research Site
Saint Priest en Jarez, France, 42270
Research Site
Toulouse Cedex 9, France, 31059
Germany
Research Site
Berlin, Germany, 13507
Research Site
Berlin, Germany, 10117
Research Site
Blankenfelde-Mahlow, Germany, 15831
Research Site
Bochum, Germany, 44803
Research Site
Bonn, Germany, 53105
Research Site
Buchholz, Germany, 21244
Research Site
Dülmen, Germany, 48249
Research Site
Frankfurt am Main, Germany, 60590
Research Site
Friedrichshafen, Germany, 88045
Research Site
Halle (Saale), Germany, 06120
Research Site
Hamburg, Germany, 20246
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Hamburg, Germany, 20354
Research Site
Kiel, Germany, 24105
Research Site
Münster, Germany, 48149
Research Site
Osnabrück, Germany, 49074
Poland
Research Site
Iwonicz Zdroj, Poland, 38-440
Research Site
Lodz, Poland, 90-265
Research Site
Lodz, Poland, 90-436
Research Site
Olsztyn, Poland, 10-228
Research Site
Poznan, Poland, 60-539
Research Site
Szczecin, Poland, 70-111
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ToruÅ", Poland, 87-100
Research Site
Warszawa, Poland, 01-192
Research Site
Wroclaw, Poland, 50-088
Research Site
Wroclaw, Poland, 51-318
Research Site
Wroclaw, Poland, 50-368
Switzerland
Research Site
Basel, Switzerland, 4031
Research Site
Bern, Switzerland, 3010
Research Site
Geneva 14, Switzerland, 1211
Research Site
Lausanne, Switzerland, 1011
Research Site
Zürich, Switzerland, 8091
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01708590     History of Changes
Other Study ID Numbers: 20120102, 2012-000651-13
Study First Received: September 10, 2012
Last Updated: May 26, 2014
Health Authority: United States: Food and Drug Administration
France: Ministry of Health
Canada: Health Canada
Germany: Ministry of Health
Poland: Ministry of Health
Switzerland: Swiss Medic

Keywords provided by Amgen:
psoriasis, brodalumab, AMG 827

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 20, 2014