Risankizumab Versus Secukinumab for Subjects With Moderate to Severe Plaque Psoriasis
Status: | Active, not recruiting |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/17/2019 |
Start Date: | May 1, 2018 |
End Date: | November 29, 2019 |
A Multicenter, Randomized, Open Label, Efficacy Assessor-Blinded Study of Risankizumab Compared to Secukinumab for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
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.
compared with secukinumab for the treatment of adult subjects with moderate to severe plaque
psoriasis who are candidates for systemic therapy.
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 /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
We found this trial at
29
sites
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