Moderate to severe plaque psoriasis MedDRA version: 18.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compared with placebo: - To evaluate the efficacy of brodalumab (210 mg every 2 weeks [Q2W]; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index (PASI; PASI 75) at week 12. - To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving success (clear [0] or almost clear [1]) on the static physician’s global assessment (sPGA) at week 12;Secondary Objective: Compared with placebo: - To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W) in clearing psoriasis, as measured by the proportion of subjects achieving PASI 100 at week 12 - To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W) in clearing psoriasis, as measured by the proportion of subjects achieving sPGA of 0 at week 12 - To evaluate maintenance of effect with continued brodalumab treatment (210 mg Q2W; and 140 mg Q2W), as measured by the proportion of subjects achieving sPGA success at week 52 - To evaluate the effect of brodalumab (210 mg Q2W; and 140 mg Q2W) on patient-reported symptoms of psoriasis, as measured by the proportion of subjects who meet the responder definition for the Psoriasis Symptom Inventory (total score = 8, with no item scores > 1) at week 12;Primary end point(s): Co-Primary: - PASI 75 at week 12 - sPGA success at week 12 ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary: - PASI 100 at week 12 - sPGA 0 at week 12 - sPGA success at week 52 (in rerandomized subjects) - Psoriasis Symptom Inventory responder definition at week 12 For other secondary endpoints, please refer to section 10.1.1 in the protocol.;Timepoint(s) of evaluation of this end point: - Week 12 for PASI 100; sPGA 0 and Psoriasis Symptom Inventory responder definition. - Week 52 for sPGA success (in rerandomized subjects) | — |
Countries
Canada, France, Germany, Poland, Switzerland, United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed