Study of Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01708603
First received: September 12, 2012
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Moderate to Severe Plaque Psoriasis
Drug: 210 mg brodalumab
Drug: 140 mg brodalumab
Drug: ustekinumab
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 and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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

  • 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


Secondary Outcome Measures:
  • 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

  • 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

  • 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 ] [ Designated as safety issue: Yes ]
    Safety profile of brodalumab

  • Subject incidence of adverse events of interest [ Time Frame: 12 weeks and 5 years ] [ 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: 1831
Study Start Date: August 2012
Estimated Study Completion Date: September 2018
Primary Completion Date: September 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 schedule 1, 2, 3, or 4.
Drug: 210 mg brodalumab
210 mg brodalumab administered SC
Experimental: 140 mg brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
Drug: 140 mg brodalumab
140 mg brodalumab administered SC
Active Comparator: ustekinumab
Administered by subcutaneous (SC) injection per the labeled dosing regimen.
Drug: ustekinumab
45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
Placebo Comparator: Placebo
Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
Drug: 210 mg brodalumab
210 mg brodalumab administered SC
Drug: placebo
Placebo administered SC

Detailed Description:

NOTE: Detailed Description: data not entered.

  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 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
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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: NCT01708603

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Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01708603     History of Changes
Other Study ID Numbers: 20120103
Study First Received: September 12, 2012
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Association (TGA)
Austria: Austrian Federal Office for Safety in Health Care
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: National Agency for Medicines and Health Products Safety (ANSM)
Hungary: National Institute for Pharmacy
Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)
Poland: The Office for Registration of Medical Products, Medical Devices and Biocidal Products
Portugal: The National Institute of Pharmacy and Medicines (INFARMED)
Spain: Medicines and Health Products Agency (AEMPS)

Keywords provided by Amgen:
psoriasis, brodalumab, AMG 827

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

ClinicalTrials.gov processed this record on October 30, 2014