Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis

NCT03478787 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M16-7662017-004932-12
• Study Type: interventional
• Target: 327
• Locations: 9 countries
• Sites: 61

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.

Conditions

Psoriasis

Keywords

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52

  Week 52

• Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52

  Week 52

• Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52

  Week 52

Study Arms (2)

Risankizumab

EXPERIMENTAL

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).

Drug: risankizumab

Secukinumab

ACTIVE COMPARATOR

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.

Drug: secukinumab

Interventions

risankizumab DRUG

Subcutaneous (SC) injection

Also known as: ABBV-066, BI 655066, SKYRIZI

Risankizumab

secukinumab DRUG

Subcutaneous (SC) injection

Also known as: Cosentyx

Secukinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (61)

Advanced Research Associates - Glendale /ID# 204335

Glendale, Arizona, 85308, United States

Location

Alliance Dermatology and MOHs /ID# 204336

Phoenix, Arizona, 85032, United States

Location

Bakersfield Derma & Skin Cance /ID# 202115

Bakersfield, California, 93309, United States

Location

Center for Dermatology Clin Res /ID# 202116

Fremont, California, 94538, United States

Location

Dermatology Res. Assoc., CA /ID# 202170

Los Angeles, California, 90045, United States

Location

UC Davis Health /ID# 202263

Sacramento, California, 95816, United States

Location

Medderm Associates /ID# 202162

San Diego, California, 92103, United States

Location

UConn Health Main /ID# 201745

Farmington, Connecticut, 06032, United States

Location

Tory P Sullivan, MD PA /ID# 202177

North Miami Beach, Florida, 33162-4708, United States

Location

Renstar Medical Research /ID# 202113

Ocala, Florida, 34470, United States

Location

Progressive Medical Research /ID# 202183

Port Orange, Florida, 32127, United States

Location

Integrated Clinical Research LLC /ID# 202152

West Palm Beach, Florida, 33406-6063, United States

Location

Dermatology Specialists Resear /ID# 202145

Louisville, Kentucky, 40241, United States

Location

Dermatology and Skin Cancer Specialists, LLC /ID# 203938

Rockville, Maryland, 20850, United States

Location

ORA, Inc. /ID# 204342

Andover, Massachusetts, 01810, United States

Location

Beth Israel Deaconess Medical Center /ID# 204340

Boston, Massachusetts, 02215-5400, United States

Location

Minnesota Clinical Study Center /ID# 202369

New Brighton, Minnesota, 55112, United States

Location

Central Dermatology, PC /ID# 202156

St Louis, Missouri, 63117, United States

Location

Psoriasis Treatment Ctr of Central NJ /ID# 202107

East Windsor, New Jersey, 08520, United States

Location

Synexus Research Cincinnati /ID# 202161

Cincinnati, Ohio, 45236, United States

Location

Oregon Derm & Res. Ctr /ID# 201652

Portland, Oregon, 97210, United States

Location

Oregon Medical Res Center PC /ID# 201651

Portland, Oregon, 97223, United States

Location

Clinical Partners, LLC /ID# 201736

Johnston, Rhode Island, 02919, United States

Location

Center for Clinical Studies - Houston (Binz) /ID# 202178

Houston, Texas, 77004-8097, United States

Location

Progressive Clinical Research /ID# 202155

San Antonio, Texas, 78229, United States

Location

Center for Clinical Studies - Webster TX /ID# 202154

Webster, Texas, 77598, United States

Location

University of Utah /ID# 204035

Salt Lake City, Utah, 84112-5500, United States

Location

Froedtert Mem Lutheran Hosp /ID# 204896

Milwaukee, Wisconsin, 53226, United States

Location

Beacon Dermatology Inc /ID# 203054

Calgary, Alberta, T3E 0B2, Canada

Location

Enverus Medical Research /ID# 203043

Surrey, British Columbia, V3V 0C6, Canada

Location

Dr. Irina Turchin PC Inc. /ID# 203052

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Eastern Canada Cutaneous Resea /ID# 203045

Halifax, Nova Scotia, B3H 1Z2, Canada

Location

Dermatrials Research /ID# 203051

Hamilton, Ontario, L8N 1Y2, Canada

Location

Dre Angelique Gagne-Henley M.D. inc. /ID# 203053

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

Dermatologique du Quebec /ID# 203050

Québec, G1V 4X7, Canada

Location

Charles Nicolle CHU Rouen /ID# 203590

Rouen, Seine-Maritime, 76031, France

Location

Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 203591

Nice, 06202, France

Location

Hopital Saint-Louis /ID# 203586

Paris, 75010, France

Location

Polyclinique Courlancy /ID# 203588

Reims, 51100, France

Location

Hopital Larrey - CHU de Toulouse /ID# 203587

Toulouse, 31059, France

Location

TU Uniklinik Munchen /ID# 203919

Munich, 80802, Germany

Location

Policlinico A. Gemelli /ID# 203009

Rome, Lazio, 00168, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 204982

Milan, Lombardy, 20122, Italy

Location

Radboud Universitair Medisch Centrum /ID# 202560

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Bravis Ziekenhuis /ID# 205232

Bergen op Zoom, North Brabant, 4624 VT, Netherlands

Location

Academisch Medical center Amsterdam /ID# 202556

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Klinika Dermatologii Pod Fortem /ID# 204180

Krakow, Lesser Poland Voivodeship, 31-302, Poland

Location

Przychodnia Specjalistyczna High-Med /ID# 203183

Warsaw, Masovian Voivodeship, 01-817, Poland

Location

Klinika Ambroziak Sp. z o.o. /ID# 203928

Warsaw, Masovian Voivodeship, 02-758, Poland

Location

KSW nr1 w Rzeszowie /ID# 203776

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

Osteo-Medic S.C. /ID# 203742

Bialystok, Podlaskie Voivodeship, 15-351, Poland

Location

Dermed Centrum Medyczne Sp. z o.o /ID# 203171

Lodz, Łódź Voivodeship, 90-265, Poland

Location

Hospital de Manises /ID# 203757

Manises, Valencia, 46940, Spain

Location

Hospital General Universitario Alicante /ID# 203764

Alicante, 03010, Spain

Location

Hospital Universitario Clinico San Cecilio /ID# 203760

Granada, 18016, Spain

Location

Hospital Universitario de la Princesa /ID# 203754

Madrid, 28006, Spain

Location

Hospital Universitario 12 de Octubre /ID# 203756

Madrid, 28041, Spain

Location

Hospital Universitario Arnau Vilanova /ID# 203763

Valencia, 46015, Spain

Location

Whipps Cross Univ Hospital /ID# 204723

London, London, City of, E11 1NR, United Kingdom

Location

Guy's and St Thomas' NHS Found /ID# 204721

London, London, City of, SE1 9RT, United Kingdom

Location

The University of Manchester /ID# 204720

Salford, M6 8HD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35050485 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab; secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: March 27, 2018
• Study Start: May 8, 2018
• Primary Completion: July 8, 2020
• Study Completion: July 8, 2020
• Last Updated: July 13, 2021
• Results First Posted: July 13, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Locations

US (28); ES (6); CA (7); FR (5); GB (3); DE (1); PL (6); IT (2); NL (3)