A study to assess the efficacy and safety in patients who have been treated for at least 6 months with secukinumab or ixekizumab and have experienced a suboptimal response and then switched to risankizumab.
- Conditions
- Plaque Psoriasis / Psoriasis VulgarisMedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2019-000904-14-IT
- Lead Sponsor
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 250
* Adult subjects 18 years and older at screening;
* Diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0);
* Subject must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing a sub-optimal response at time of Screening and Baseline visits
* Sub-optimal response to Secukinumab and Ixekizumab inhibitors is defined as:
- Body Surface Area (BSA) 3% - <10% and
- Static Physician Global Assessment 2/3
* Subject must be eligible for continued biologic therapy as assessed by the investigator
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 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
* History of erythrodermic psoriasis, generalized or localized pustular
psoriasis, medication-induced or medication-exacerbated psoriasis, or
new onset guttate psoriasis, psoriatic arthritis;
* No active skin disease other than plaque psoriasis that could interfere
with the assessment of plaque psoriasis;
* History of chronic infections including HIV, viral hepatitis (hepatitis B,
hepatitis C), and/ or active tuberculosis. Subjects with a positive
QuantiFERON®-TB /PPD test result may participate in the study if
further work up (according to local
practice/guidelines) establishes conclusively that the subject has no
evidence of active tuberculosis. If presence of latent tuberculosis is
established, then treatment must have been initiated and maintained
according to local country guidelines;
* Active systemic infection during the last 2 weeks prior to Baseline Visit
(exception: common cold) as assessed by the investigator;
* History of any documented active or suspected malignancy or history
of any malignancy within the last 5 years except for successfully treated
non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the
cervix;
* History of major surgery performed within 12 weeks prior to
randomization or planned to be performed during the conduct of the trial
as assessed by the investigator;
* Previous exposure to risankizumab or any IL-23 inhibitors.
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