Psoriasis Clinical Trial
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab
Summary
This study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms.
Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection at Week 0, Week 4, and then every 12 weeks for 52 Weeks (With the last dose being administered at Week 40). An additional visit will occur at Week 8 for a physical exam and questionnaire collection. A final follow-up phone call will occur at Week 60.
Eligibility Criteria
Inclusion Criteria:
Diagnosed with moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0).
Participant must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing suboptimal response at time of Screening and Baseline visits.
Participant must have a Body Surface Area (BSA) 3%- <10% and Static Physician Global Assessment (sPGA) 2/3
Participant must be eligible for continued biologic therapy as assessed by the investigator.
Exclusion Criteria:
History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis, psoriatic arthritis.
Participant with active skin disease other than plaque psoriasis that could interfere with the assessment of plaque psoriasis.
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.
History of major surgery within 12 weeks prior to Baseline or planned to be performed during the conduct of the trial as assessed by the investigator.
Participant with exposure to risankizumab or any IL-23 inhibitors.
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There are 57 Locations for this study
Phoenix Arizona, 85032, United States
Hot Springs Arkansas, 71913, United States
North Little Rock Arkansas, 72117, United States
Bakersfield California, 93309, United States
Sacramento California, 95816, United States
Cromwell Connecticut, 06416, United States
Miami Florida, 33173, United States
Sandy Springs Georgia, 30328, United States
Rolling Meadows Illinois, 60008, United States
Indianapolis Indiana, 46256, United States
Rockville Maryland, 20850, United States
Kirksville Missouri, 63501, United States
Saint Louis Missouri, 63117, United States
Cleveland Ohio, 44106, United States
Pittsburgh Pennsylvania, 15260, United States
Johnston Rhode Island, 02919, United States
Arlington Texas, 76011, United States
Bellaire Texas, 77401, United States
Dallas Texas, 75231, United States
Dallas Texas, 75246, United States
Kogarah New South Wales, 2217, Australia
Woolloongabba Queensland, 4102, Australia
Carlton Victoria, 3053, Australia
Fremantle Western Australia, 6160, Australia
Erlangen Bayern, 91054, Germany
Frankfurt am Main Hessen, 60590, Germany
Berlin , 10117, Germany
Bochum , 44791, Germany
Luebeck , 23538, Germany
Mahlow , 15831, Germany
Memmingen , 87700, Germany
Munich , 81675, Germany
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Afula , 18341, Israel
Petakh Tikva , 49414, Israel
Rozzano Milano, 20089, Italy
Bologna , 40138, Italy
Cagliari , 09124, Italy
Milan , 20122, Italy
Modena , 41124, Italy
Napoli , 80138, Italy
Badalona Barcelona, 08916, Spain
Alcorcon Madrid, 28922, Spain
Barcelona , 08003, Spain
Cadiz , 11009, Spain
Madrid , 28046, Spain
Valencia , 46026, Spain
Taichung , 40201, Taiwan
Taipei City , 100, Taiwan
Taipei City , 10449, Taiwan
Taoyuan City , 333, Taiwan
Kirkcaldy Fife, KY2 5, United Kingdom
Dudley , DY1 2, United Kingdom
Leeds , LS9 7, United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
Salford , M6 8H, United Kingdom
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