Status:
COMPLETED
Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
Lead Sponsor:
AbbVie
Conditions:
Psoriasis
Eligibility:
18+ years
Phase:
PHASE3
Brief 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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2020
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT03478787
Start Date
May 8 2018
End Date
July 8 2020
Last Update
July 13 2021
Active Locations (61)
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1
Advanced Research Associates - Glendale /ID# 204335
Glendale, Arizona, United States, 85308
2
Alliance Dermatology and MOHs /ID# 204336
Phoenix, Arizona, United States, 85032
3
Bakersfield Derma & Skin Cance /ID# 202115
Bakersfield, California, United States, 93309
4
Center for Dermatology Clin Res /ID# 202116
Fremont, California, United States, 94538