EUCTR2012-000651-13-DE
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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Amgen Inc.
- Enrollment
- 600
- Status
- Active, Not Recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
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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