Moderate to severe plaque psoriasis MedDRA version: 17.1 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 1710 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
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 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Placebo-family Objectives 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 Primary Ustekinumab-family Objectives Compared with ustekinumab: • To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W for subjects = 100 kg with 210 mg dosage for subjects > 100 kg) in clearing psoriasis in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving PASI 100 at week 12;Primary end point(s): Co-Primary: brodalumab arms vs placebo • PASI 75 at week 12 • sPGA success at week 12 Primary: brodalumab vs ustekinumab • PASI 100 at week 12 - 210 mg Q2W - 140 mg Q2W for subjects = 100 kg and 210 mg Q2W for subjects > 100 kg;Timepoint(s) of evaluation of this end point: Week 12;Secondary Objective: Placebo-family Objectives: - To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W) compared with placebo: PASI 100 at week 12; sPGA of 0 at week 12; patient-reported symptoms of psoriasis at week 12. Ustekinumab-family Objectives: Compared with Ustekinumab - To evaluate the efficacy of brodalumab (140 mg Q2W): PASI 100 at week 12 - To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W for subjects = 100 kg with 210 mg dosage for subjects > 100 kg): PASI 75 at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary: brodalumab arms vs placebo • PASI 100 at week 12 • sPGA of 0 at week 12 • Psoriasis Symptom Inventory responder definition at week 12 Key Secondary: brodalumab vs ustekinumab • PASI 100 at week 12 - 140 mg Q2W • PASI 75 at week 12 - 210 mg Q2W - 140 mg Q2W for subjects = 100 kg and 210 mg Q2W for subjects > 100 kg For other secondary endpoints, please refer to section 10.1.1 in the protocol.;Timepoint(s) of evaluation of this end point: week 12 | — |
Countries
Australia, Austria, Canada, Czech Republic, France, Germany, Hungary, Netherlands, Poland, Portugal, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed