Psoriasis Clinical Trial
Official title:
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
Verified date | June 2021 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 327 |
Est. completion date | July 8, 2020 |
Est. primary completion date | July 8, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Beacon Dermatology Inc /ID# 203054 | Calgary | Alberta |
Canada | Dr. Irina Turchin PC Inc. /ID# 203052 | Fredericton | New Brunswick |
Canada | Eastern Canada Cutaneous Resea /ID# 203045 | Halifax | Nova Scotia |
Canada | Dermatrials Research /ID# 203051 | Hamilton | Ontario |
Canada | Dermatologique du Quebec /ID# 203050 | Quebec | |
Canada | Dre Angelique Gagne-Henley M.D. inc. /ID# 203053 | Saint-Jerome | Quebec |
Canada | Enverus Medical Research /ID# 203043 | Surrey | British Columbia |
France | Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 203591 | Nice | |
France | Hopital Saint-Louis /ID# 203586 | Paris | |
France | Polyclinique Courlancy /ID# 203588 | Reims | |
France | Charles Nicolle CHU Rouen /ID# 203590 | Rouen CEDEX | Seine-Maritime |
France | Hopital Larrey - CHU de Toulouse /ID# 203587 | Toulouse | |
Germany | TU Uniklinik Munchen /ID# 203919 | Munich | |
Italy | Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 204982 | Milan | Lombardia |
Italy | Policlinico A. Gemelli /ID# 203009 | Roma | Lazio |
Netherlands | Academisch Medical center Amsterdam /ID# 202556 | Amsterdam | Noord-Holland |
Netherlands | Bravis Ziekenhuis /ID# 205232 | Bergen op Zoom | Noord-Brabant |
Netherlands | Radboud Universitair Medisch Centrum /ID# 202560 | Nijmegen | Gelderland |
Poland | Osteo-Medic S.C. /ID# 203742 | Bialystok | Podlaskie |
Poland | Klinika Dermatologii Pod Fortem /ID# 204180 | Krakow | Malopolskie |
Poland | Dermed Centrum Medyczne Sp. z o.o /ID# 203171 | Lodz | Lodzkie |
Poland | KSW nr1 w Rzeszowie /ID# 203776 | Rzeszow | Podkarpackie |
Poland | Klinika Ambroziak Sp. z o.o. /ID# 203928 | Warsaw | Mazowieckie |
Poland | Przychodnia Specjalistyczna High-Med /ID# 203183 | Warsaw | Mazowieckie |
Spain | Hospital General Universitario Alicante /ID# 203764 | Alicante | |
Spain | Hospital Universitario Clinico San Cecilio /ID# 203760 | Granada | |
Spain | Hospital Universitario 12 de Octubre /ID# 203756 | Madrid | |
Spain | Hospital Universitario de la Princesa /ID# 203754 | Madrid | |
Spain | Hospital de Manises /ID# 203757 | Manises | Valencia |
Spain | Hospital Universitario Arnau Vilanova /ID# 203763 | Valencia | |
United Kingdom | Guy's and St Thomas' NHS Found /ID# 204721 | London | London, City Of |
United Kingdom | Whipps Cross Univ Hospital /ID# 204723 | London | London, City Of |
United Kingdom | The University of Manchester /ID# 204720 | Salford | |
United States | ORA, Inc. /ID# 204342 | Andover | Massachusetts |
United States | Bakersfield Derma & Skin Cance /ID# 202115 | Bakersfield | California |
United States | Beth Israel Deaconess Medical Center /ID# 204340 | Boston | Massachusetts |
United States | Synexus Research Cincinnati /ID# 202161 | Cincinnati | Ohio |
United States | Psoriasis Treatment Ctr of Central NJ /ID# 202107 | East Windsor | New Jersey |
United States | UConn Health Main /ID# 201745 | Farmington | Connecticut |
United States | Center for Dermatology Clin Res /ID# 202116 | Fremont | California |
United States | Advanced Research Associates - Glendale /ID# 204335 | Glendale | Arizona |
United States | Center for Clinical Studies - Houston (Binz) /ID# 202178 | Houston | Texas |
United States | Clinical Partners, LLC /ID# 201736 | Johnston | Rhode Island |
United States | Dermatology Res. Assoc., CA /ID# 202170 | Los Angeles | California |
United States | Dermatology Specialists Resear /ID# 202145 | Louisville | Kentucky |
United States | Froedtert Mem Lutheran Hosp /ID# 204896 | Milwaukee | Wisconsin |
United States | Minnesota Clinical Study Center /ID# 202369 | New Brighton | Minnesota |
United States | Tory P Sullivan, MD PA /ID# 202177 | North Miami Beach | Florida |
United States | Renstar Medical Research /ID# 202113 | Ocala | Florida |
United States | Alliance Dermatology and MOHs /ID# 204336 | Phoenix | Arizona |
United States | Progressive Medical Research /ID# 202183 | Port Orange | Florida |
United States | Oregon Derm & Res. Ctr /ID# 201652 | Portland | Oregon |
United States | Oregon Medical Res Center PC /ID# 201651 | Portland | Oregon |
United States | Dermatology and Skin Cancer Specialists, LLC /ID# 203938 | Rockville | Maryland |
United States | UC Davis Health /ID# 202263 | Sacramento | California |
United States | Central Dermatology, PC /ID# 202156 | Saint Louis | Missouri |
United States | University of Utah /ID# 204035 | Salt Lake City | Utah |
United States | Progressive Clinical Research /ID# 202155 | San Antonio | Texas |
United States | Medderm Associates /ID# 202162 | San Diego | California |
United States | Center for Clinical Studies - Webster TX /ID# 202154 | Webster | Texas |
United States | Integrated Clinical Research LLC /ID# 202152 | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
United States, Canada, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data. | Week 16 | |
Primary | Percentage of Participants With a PASI 90 at Week 52 | The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | Week 52 | |
Secondary | Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | Week 52 | |
Secondary | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all 3; Almost clear (1) = mean > 0, < 1.5; Mild (2) = mean = 1.5, < 2.5; Moderate (3) = mean = 2.5, < 3.5; and Severe (4) = mean = 3.5. | Week 52 | |
Secondary | Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52 | The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. | Week 52 |
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