Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Kyntheum
Product Name: brodalumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: BRODALUMAB
CAS Number: 1174395-19-7
Other descriptive name: Kyntheu
Sponsors
Herlev and Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients must be > 18 • Have had moderate-to-severe plaque psoriasis (PASI>10) and a PASI=6 at screening. • Be eligible to receive biological treatment • Have been treated with anti-IL-17A (ixekizumab and/or secukinumab) with treatment failure, defined as either: o Primary failure: =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with clinically significant disorders • Patients with active TB/serious infections • Any psychiatric condition which in the Investigators opinion would preclude the patient from adhering to the protocol or completing the study per protocol. Patients with previous endogene depression. • Pregnancy • Nursing • Women of child-bearing potential must use effective contraception which includes IUD, oral, injected or implanted hormonal device, hormone patch, vaginal hormonal ring or sterilization. Occlusive cap or condom with spermicidal cream is not considered safe contraception. Post-menopausal women (>12 months of amenorrhea) are allowed not to use contraception. • Patients who have received any weakened vaccines 6 weeks prior to day 0 or who are planning to receive a weakened vaccine during the study • Allergy to brodalumab or any of the other ingredients in Kyntheum® • Active Crohn’s disease • Suicidal ideation and/or behavior
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study will evaluate brodalumab treatment in patients with moderate-to-severe psoriasis previously treated with anti-IL-17A with primary or secondary failure of treatment. 1. Percentage of patients achieving PASI75 or an absolute PASI =2 after 3 months. 2. Percentage of patients achieving PASI90 after 3 months. ;Secondary Objective: 1. Percentage of patients achieving PASI75 or an absolute PASI =2 after 6 and 12 months respectively. 2. Percentage of patients achieving PASI90 after 6 and 12 month respectively. 3. Percentage of patients achieving PASI100 after 3, 6, and 12 months respectively. 4. Changes in DLQI score after 3, 6, and 12 months treatment with brodalumab compared to DLQI score before treatment with brodlaumab. 5. Changes in inflammatory cytokines in blood after treatment and at each evaluation point compared to before treatment. 6. Changes in oxidative stress level after treatment and at each evaluation point compared to before treatment. ;Primary end point(s): 1. Percentage of patients achieving PASI75 or an absolute PASI =2 after 3 months. 2. Percentage of patients achieving PASI90 after 3 months. ;Timepoint(s) of evaluation of this end point: 1/7-20 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Please see section E2;Timepoint(s) of evaluation of this end point: 1/7-20 | — |
Countries
Denmark
Contacts
Public ContactDept of Dermatology and Allergy
Herlev and Gentofte Hospital
Outcome results
None listed