Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
- Registration Number
- NCT03478787
- Lead Sponsor
- AbbVie
- 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 candidates for systemic therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 327
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Secukinumab secukinumab Participants randomized to secukinumab receive 2 injections of active secukinumab (300 mg total dosage) SC at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48. Risankizumab risankizumab Participants randomized to risankizumab receive 2 injections of active risankizumab (150 mg total dosage) subcutaneously (SC) at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
- Primary Outcome Measures
Name Time Method Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 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.
Percentage of Participants With a PASI 90 at Week 52 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52 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.
Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52 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.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52 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.
Trial Locations
- Locations (61)
Beacon Dermatology Inc /ID# 203054
🇨🇦Calgary, Alberta, Canada
Hopital Saint-Louis /ID# 203586
🇫🇷Paris, France
Progressive Medical Research /ID# 202183
🇺🇸Port Orange, Florida, United States
Central Dermatology, PC /ID# 202156
🇺🇸Saint Louis, Missouri, United States
Oregon Derm & Res. Ctr /ID# 201652
🇺🇸Portland, Oregon, United States
Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 203591
🇫🇷Nice, France
Hopital Larrey - CHU de Toulouse /ID# 203587
🇫🇷Toulouse, France
Dermatology Specialists Resear /ID# 202145
🇺🇸Louisville, Kentucky, United States
Policlinico A. Gemelli /ID# 203009
🇮🇹Roma, Lazio, Italy
Polyclinique Courlancy /ID# 203588
🇫🇷Reims, France
Hospital General Universitario Alicante /ID# 203764
🇪🇸Alicante, Spain
Whipps Cross Univ Hospital /ID# 204723
🇬🇧London, London, City Of, United Kingdom
Guy's and St Thomas' NHS Found /ID# 204721
🇬🇧London, London, City Of, United Kingdom
Dermatologique du Quebec /ID# 203050
🇨🇦Quebec, Canada
Hospital Universitario Clinico San Cecilio /ID# 203760
🇪🇸Granada, Spain
TU Uniklinik Munchen /ID# 203919
🇩🇪Munich, Germany
Dre Angelique Gagne-Henley M.D. inc. /ID# 203053
🇨🇦Saint-Jerome, Quebec, Canada
Hospital Universitario 12 de Octubre /ID# 203756
🇪🇸Madrid, Spain
Bravis Ziekenhuis /ID# 205232
🇳🇱Bergen op Zoom, Noord-Brabant, Netherlands
The University of Manchester /ID# 204720
🇬🇧Salford, United Kingdom
Hospital Universitario de la Princesa /ID# 203754
🇪🇸Madrid, Spain
Hospital de Manises /ID# 203757
🇪🇸Manises, Valencia, Spain
Center for Dermatology Clin Res /ID# 202116
🇺🇸Fremont, California, United States
UC Davis Health /ID# 202263
🇺🇸Sacramento, California, United States
Renstar Medical Research /ID# 202113
🇺🇸Ocala, Florida, United States
Dermatology and Skin Cancer Specialists, LLC /ID# 203938
🇺🇸Rockville, Maryland, United States
Eastern Canada Cutaneous Resea /ID# 203045
🇨🇦Halifax, Nova Scotia, Canada
Radboud Universitair Medisch Centrum /ID# 202560
🇳🇱Nijmegen, Gelderland, Netherlands
University of Utah /ID# 204035
🇺🇸Salt Lake City, Utah, United States
Integrated Clinical Research LLC /ID# 202152
🇺🇸West Palm Beach, Florida, United States
Minnesota Clinical Study Center /ID# 202369
🇺🇸New Brighton, Minnesota, United States
Alliance Dermatology and MOHs /ID# 204336
🇺🇸Phoenix, Arizona, United States
Bakersfield Derma & Skin Cance /ID# 202115
🇺🇸Bakersfield, California, United States
Dermatology Res. Assoc., CA /ID# 202170
🇺🇸Los Angeles, California, United States
Center for Clinical Studies - Houston (Binz) /ID# 202178
🇺🇸Houston, Texas, United States
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 204982
🇮🇹Milan, Lombardia, Italy
Dermed Centrum Medyczne Sp. z o.o /ID# 203171
🇵🇱Lodz, Lodzkie, Poland
Klinika Ambroziak Sp. z o.o. /ID# 203928
🇵🇱Warsaw, Mazowieckie, Poland
Dr. Irina Turchin PC Inc. /ID# 203052
🇨🇦Fredericton, New Brunswick, Canada
Advanced Research Associates - Glendale /ID# 204335
🇺🇸Glendale, Arizona, 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
Academisch Medical center Amsterdam /ID# 202556
🇳🇱Amsterdam, Noord-Holland, Netherlands
Klinika Dermatologii Pod Fortem /ID# 204180
🇵🇱Krakow, Malopolskie, Poland
Charles Nicolle CHU Rouen /ID# 203590
🇫🇷Rouen CEDEX, Seine-Maritime, France
Enverus Medical Research /ID# 203043
🇨🇦Surrey, British Columbia, Canada
Przychodnia Specjalistyczna High-Med /ID# 203183
🇵🇱Warsaw, Mazowieckie, Poland
KSW nr1 w Rzeszowie /ID# 203776
🇵🇱Rzeszow, Podkarpackie, Poland
Osteo-Medic S.C. /ID# 203742
🇵🇱Białystok, Podlaskie, Poland
Medderm Associates /ID# 202162
🇺🇸San Diego, California, United States
Tory P Sullivan, MD PA /ID# 202177
🇺🇸North Miami Beach, Florida, United States
Oregon Medical Res Center PC /ID# 201651
🇺🇸Portland, Oregon, United States
Clinical Partners, LLC /ID# 201736
🇺🇸Johnston, Rhode Island, United States
ORA, Inc. /ID# 204342
🇺🇸Andover, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 204340
🇺🇸Boston, Massachusetts, United States
Synexus Research Cincinnati /ID# 202161
🇺🇸Cincinnati, Ohio, United States
Progressive Clinical Research /ID# 202155
🇺🇸San Antonio, Texas, United States
Center for Clinical Studies - Webster TX /ID# 202154
🇺🇸Webster, Texas, United States
Froedtert Mem Lutheran Hosp /ID# 204896
🇺🇸Milwaukee, Wisconsin, United States
Dermatrials Research /ID# 203051
🇨🇦Hamilton, Ontario, Canada
Hospital Universitario Arnau Vilanova /ID# 203763
🇪🇸Valencia, Spain