Efficacy of brodalumab in patients with psoriasis with failure of other anti-IL-17 treatments
- Conditions
- PsoriasisMedDRA version: 20.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-000097-30-DK
- Lead Sponsor
- Herlev and Gentofte Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
•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:
oPrimary failure: oSecondary failure: Initial response, but with subsequent loss of efficacy
•Patients must have given their informed consent to the protocol and the clinical procedures
•Be able to speak and understand Danish
•No systemic or biological treatment for psoriasis in the last 4 weeks.
•No concomitant methotrexate treatment
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method