Clinical trial NCT03478787: Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Plaque Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-03-27
Enrollment: 327
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a PASI 90 at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52
timeFrame: Week 52
measure: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52
timeFrame: Week 52
measure: Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Advanced Research Associates - Glendale /ID# 204335
state: Arizona
city: Phoenix
country: United States
facility: Alliance Dermatology and MOHs /ID# 204336
state: Arizona
city: Bakersfield
country: United States
facility: Bakersfield Derma & Skin Cance /ID# 202115
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clin Res /ID# 202116
state: California
city: Los Angeles
country: United States
facility: Dermatology Res. Assoc., CA /ID# 202170
state: California
city: Sacramento
country: United States
facility: UC Davis Health /ID# 202263
state: California
city: San Diego
country: United States
facility: Medderm Associates /ID# 202162
state: California
city: Farmington
country: United States
facility: UConn Health Main /ID# 201745
state: Connecticut
city: North Miami Beach
country: United States
facility: Tory P Sullivan, MD PA /ID# 202177
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research /ID# 202113
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research /ID# 202183
state: Florida
city: West Palm Beach
country: United States
facility: Integrated Clinical Research LLC /ID# 202152
state: Florida
city: Louisville
country: United States
facility: Dermatology Specialists Resear /ID# 202145
state: Kentucky
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists, LLC /ID# 203938
state: Maryland
city: Andover
country: United States
facility: ORA, Inc. /ID# 204342
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 204340
state: Massachusetts
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center /ID# 202369
state: Minnesota
city: Saint Louis
country: United States
facility: Central Dermatology, PC /ID# 202156
state: Missouri
city: East Windsor
country: United States
facility: Psoriasis Treatment Ctr of Central NJ /ID# 202107
state: New Jersey
city: Cincinnati
country: United States
facility: Synexus Research Cincinnati /ID# 202161
state: Ohio
city: Portland
country: United States
facility: Oregon Derm & Res. Ctr /ID# 201652
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Res Center PC /ID# 201651
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners, LLC /ID# 201736
state: Rhode Island
city: Houston
country: United States
facility: Center for Clinical Studies - Houston (Binz) /ID# 202178
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research /ID# 202155
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies - Webster TX /ID# 202154
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah /ID# 204035
state: Utah
city: Milwaukee
country: United States
facility: Froedtert Mem Lutheran Hosp /ID# 204896
state: Wisconsin
city: Calgary
country: Canada
facility: Beacon Dermatology Inc /ID# 203054
state: Alberta
city: Surrey
country: Canada
facility: Enverus Medical Research /ID# 203043
state: British Columbia
city: Fredericton
country: Canada
facility: Dr. Irina Turchin PC Inc. /ID# 203052
state: New Brunswick
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Resea /ID# 203045
state: Nova Scotia
city: Hamilton
country: Canada
facility: Dermatrials Research /ID# 203051
state: Ontario
city: Saint-Jerome
country: Canada
facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 203053
state: Quebec
city: Quebec
country: Canada
facility: Dermatologique du Quebec /ID# 203050
city: Rouen CEDEX
country: France
facility: Charles Nicolle CHU Rouen /ID# 203590
state: Seine-Maritime
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 203591
city: Paris
country: France
facility: Hopital Saint-Louis /ID# 203586
city: Reims
country: France
facility: Polyclinique Courlancy /ID# 203588
city: Toulouse
country: France
facility: Hopital Larrey - CHU de Toulouse /ID# 203587
city: Munich
country: Germany
facility: TU Uniklinik Munchen /ID# 203919
city: Roma
country: Italy
facility: Policlinico A. Gemelli /ID# 203009
state: Lazio
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 204982
state: Lombardia
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum /ID# 202560
state: Gelderland
city: Bergen op Zoom
country: Netherlands
facility: Bravis Ziekenhuis /ID# 205232
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Academisch Medical center Amsterdam /ID# 202556
state: Noord-Holland
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne Sp. z o.o /ID# 203171
state: Lodzkie
city: Krakow
country: Poland
facility: Klinika Dermatologii Pod Fortem /ID# 204180
state: Malopolskie
city: Warsaw
country: Poland
facility: Przychodnia Specjalistyczna High-Med /ID# 203183
state: Mazowieckie
city: Warsaw
country: Poland
facility: Klinika Ambroziak Sp. z o.o. /ID# 203928
state: Mazowieckie
city: Rzeszow
country: Poland
facility: KSW nr1 w Rzeszowie /ID# 203776
state: Podkarpackie
city: Białystok
country: Poland
facility: Osteo-Medic S.C. /ID# 203742
state: Podlaskie
city: Manises
country: Spain
facility: Hospital de Manises /ID# 203757
state: Valencia
city: Alicante
country: Spain
facility: Hospital General Universitario Alicante /ID# 203764
city: Granada
country: Spain
facility: Hospital Universitario Clinico San Cecilio /ID# 203760
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa /ID# 203754
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 203756
city: Valencia
country: Spain
facility: Hospital Universitario Arnau Vilanova /ID# 203763
city: London
country: United Kingdom
facility: Whipps Cross Univ Hospital /ID# 204723
state: London, City Of
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Found /ID# 204721
state: London, City Of
city: Salford
country: United Kingdom
facility: The University of Manchester /ID# 204720
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Crowley JJ, Langley RG, Gordon KB, Pinter A, Ferris LK, Rubant S, Photowala H, Xue Z, Wu T, Zhan T, Beeck S, Shah M, Warren RB. Efficacy of Risankizumab versus Secukinumab in Patients with Moderate-to-Severe Psoriasis: Subgroup Analysis from the IMMerge Study. Dermatol Ther (Heidelb). 2022 Feb;12(2):561-575. doi: 10.1007/s13555-021-00679-6. Epub 2022 Jan 20.