Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Trial end date: 2020-07-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the Baseline Visit

• Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis

• Subject must be a candidate for systemic therapy as assessed by the investigator;

• Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound.

Exclusion Criteria:

• History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis; or 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/purified protein derivative (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)

• 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

• Previous exposure to risankizumab

• Previous exposure to secukinumab