L40.0
Conditions
Interventions
Group 1: The recommended dose of Brodalumab (Kyntheum®) is 210 mg administered as a subcutaneous injection at week 0, 1 and 2, followed by 210 mg every 2 weeks (according to SmPC)
Sponsors
LEO Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Adult patients (= 18 years). 2) Patients must be a candidate for systemic therapy with Kyntheum® according to SmPC and local guidelines. 3) Decision to start treatment with Kyntheum® in a patient was taken before enrolment in the study. 4) Patients must have understood and voluntarily signed the ICF.
Exclusion criteria
Exclusion criteria: 1) Patients who are enrolled in any interventional clinical trial in parallel. 2) Patients who are already treated or have been previously treated with Kyntheum® before enrolment. 3) Patients, who did not sign the informed consent or incapacitated patients, who are not able to provide informed consent and/ or are under institutionalized care.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1) Short term effectiveness during induction phase (until week 12). 2) Long term effectiveness of continued Kyntheum® treatment as measured by the proportion of patients over time on a quarterly basis and at week 52. 3) Description of the frequency of adverse events. 4) Description of patient profiles with regard to demographics, disease severity, previous treatment regimens, satisfaction with previous treatment and reasons for choosing Kyntheum®. 5) Patient Reported Outcomes (PROs) at week 12 and week 52. | — |
Primary
| Measure | Time frame |
|---|---|
| 1) Proportion of patients achieving an absolute PASI value of <= 3 at week 12. 2) Proportion of patients who continued with Kyntheum® after 12 weeks of treatment achieving sPGA success (defined as clear = 0 and almost clear = 1) at week 52. | — |
Countries
Germany
Contacts
Public ContactMario Hubo
LEO Pharma GmbH
Outcome results
None listed