Plaque Psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug: • Serum aspartate transaminase (AST) 3,000/µL; • Absolute neutrophil count (ANC) > 1,500/µL; • Platelet count > 100,000/µL; • Hemoglobin > 8 g/dL. 2. Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the Baseline Visit; 3. Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis • Subject has = 10% BSA psoriasis involvement, sPGA score of = 3, and PASI = 12 at Screening and Baseline Visit; 4. Subject must be a candidate for systemic therapy as assessed by the investigator; 5. Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound. 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 233 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 77
Exclusion criteria
Exclusion criteria: 1. No history of: • Erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis; • Active skin disease other than psoriasis that could interfere with the assessment of psoriasis; • 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. The patient will not be eligible for randomization if latent tuberculosis is present and is untreated as per local guidelines. Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold) prior to Baseline Visit, as assessed by the investigator; 2. No 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; 3. No previous exposure to risankizumab; 4. No previous exposure to secukinumab; 5. Subject must not have been treated with any investigational drug within 30 days or 5 half lives of the drug (whichever is longer) prior to the first dose of study drug or currently be enrolled in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy. ;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: Week 52, Week 16;Primary end point(s): The 2 primary endpoints are: • Proportion of subjects achieving a PASI 90 response at Week 52; superiority of risankizumab vs. secukinumab. • Proportion of subjects achieving a PASI 90 response at Week 16; non-inferiority of risankizumab vs. secukinumab with non-inferiority margin of 12%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The multiplicity-controlled key secondary endpoints are: • Proportion of subjects achieving a PASI 100 response at Week 52; superiority of risankizumab vs. secukinumab; • Proportion of subjects achieving an sPGA 0 or 1 at Week 52; superiority of risankizumab vs. secukinumab; • Proportion of subjects achieving a PASI 75 response at Week 52; superiority of risankizumab vs. secukinumab. Other efficacy endpoints include change and percent change from baseline in PASI and body surface area (BSA) as well as multiple levels of PASI and sPGA responses at all visits.;Timepoint(s) of evaluation of this end point: Week 52 | — |
Countries
Australia, Canada, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed