A Study to Test the Effect and Safety of Brodalumab Compared With Placebo and Ustekinumab and the Results of Changing Strength or Frequency of Brodalumab in People with Moderate to Severe Plaque Psoriasis: AMAGINE-2

• Conditions: Moderate to severe plaque psoriasis; MedDRA version: 17.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2012-000656-34-NL
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-18
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1800

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 1710
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

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 ustekinumab and/or 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 15 weeks after the last dose (if discontinuing before week 52) or for 8 weeks after the last dose (if discontinuing at or after week 52).

Study & Design

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