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Clinical Trials/EUCTR2012-000651-13-PL
EUCTR2012-000651-13-PL
Active, Not Recruiting
N/A

A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe PlaquePsoriasis: AMAGINE-1 - AMAGINE-1

Amgen Inc.0 sites600 target enrollmentMay 18, 2012
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ConditionsModerate to severe plaque psoriasisMedDRA version: 18.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Overview

Phase
N/A
Intervention
Not specified
Conditions
Moderate to severe plaque psoriasis
Sponsor
Amgen Inc.
Enrollment
600
Status
Active, Not Recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 18, 2012
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Amgen Inc.

Eligibility Criteria

Inclusion Criteria

  • •\- Subject has provided informed consent.
  • •\- Subject is \= 18 and \= 75 years of age at time of screening.
  • •\- Subject has had stable moderate to severe plaque psoriasis for at least 6 months before first dose of IP (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).
  • •\- 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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 570
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •\- Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the investigator to be clinically significant and uncontrolled.
  • •\- Subject has any concurrent medical condition that, in the opinion of the
  • •investigator, could cause this study to be detrimental to the subject.
  • •\- Subject has used anti\-IL\-17 biologic therapy ever, or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.
  • •\- Subject currently is enrolled in another investigational device or drug
  • •study, or less than 30 days since ending another investigational device or
  • •drug study(s), or receiving other investigational agent(s).
  • •\- Other investigational procedures are excluded.
  • •\- Subject has known sensitivity to any of the products or components to be
  • •administered during dosing.

Outcomes

Primary Outcomes

Not specified

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