Status:
COMPLETED
A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy
Lead Sponsor:
AbbVie
Conditions:
Psoriasis
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM provided as study medication in participants with moderate to severe plaque psoriasi...
Detailed Description
The efficacy analysis was performed in the Intent to Treat (ITT) set which included all participants who were randomized. The safety analysis was performed in the safety set which included all partici...
Eligibility Criteria
Inclusion
- Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first administration of study drug. Duration since diagnosis may be reported by the participant
- Participant has stable moderate to severe plaque psoriasis (body surface area \[BSA\] \>10, Psoriasis Area and Severity Index \[PASI\] \>10, and Dermatology Quality of Life Index \[DLQI\] \>10) with or without psoriatic arthritis at Baseline
- Must be naïve to and candidate for systemic therapy, as assessed by the investigator
- Participant has an inadequate response, intolerance or contraindication to topical psoriasis treatment
Exclusion
- Participants with non-plaque forms of psoriasis
- Participant has previously received systemic therapy for psoriasis, whether biologic or non-biologic or photochemotherapy
- Active systemic infection during the last 2 weeks (exception: common cold) prior to screening.
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
- Participant has any condition or contraindication to Fumaderm that would preclude the patient's participation in the present study
Key Trial Info
Start Date :
August 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03255382
Start Date
August 22 2017
End Date
July 6 2018
Last Update
September 13 2019
Active Locations (23)
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1
Universitaetsklinik Heidelberg /ID# 161014
Heidelberg, Baden-Wurttemberg, Germany, 69120
2
Universitaetsklinikum Erlangen /ID# 161035
Erlangen, Bavaria, Germany, 91054
3
Universitatsklinikum Frankfurt /ID# 161036
Frankfurt am Main, Hesse, Germany, 60590
4
Universitatsklinikum Munster /ID# 165739
Munster, Lower Saxony, Germany, 48149