Plaque psoriasis psoriasis
Conditions
Interventions
Subjects who are eligible for this study, will be randomized to receive
risankizumab or secukinumab in a 1:1 ratio. The study is
designed to randomize approximately 310 subjects (155 subjects/arm).
Sponsors
AbbVie
Eligibility
Age
18 Years to 99 Years
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.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; noninferiority of risankizumab vs. secukinumab with non-inferiority margin of 12%. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 a 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. | — |
Countries
Netherlands
Outcome results
None listed