A Study to Test the Effect and Safety of Brodalumab Compared With Placebo and the Results of Stopping and Restarting Brodalumab Treatment in People with Moderate to Severe Plaque Psoriasis: AMAGINE-1

• Conditions: Moderate to severe plaque psoriasis; MedDRA version: 18.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2012-000651-13-PL
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-18
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

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
F.1.3.1 Number of subjects for this age range 30

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.

- For women: pregnant or breast feeding, or planning to become pregnant
while enrolled in the study and for 8 weeks after the last dose of IP.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified