Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478787
• Other study ID #: M16-766
• Secondary ID: 2017-004932-12
• Status: Completed
• Phase: Phase 3
• Start date: May 8, 2018
• Est. completion date: July 8, 2020

Study information

• Verified date: June 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• risankizumab
Subcutaneous (SC) injection
• secukinumab
Subcutaneous (SC) injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

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