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ACTIVE NOT RECRUITING

NCT06333860

PHASE4

A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body)

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

Psoriasis is a long-term skin disease which causes red, itchy, scaly patches most commonly on the knees, elbows, scalp, and torso (chest, back, and abdomen). In participants with psoriasis, certain skin cells multiply much faster and the skin can develop rough patches that may be red or white with scales. There are many types of psoriasis, but plaque psoriasis is the most common. The exact cause of psoriasis is unknown, but researchers think it may be caused by the body's immune system not working properly. This study is designed to enroll 336 participants 18 years of age and older with have been diagnosed with moderate chronic plaque psoriasis for at least 6 months prior to Baseline (Day 1) and who have not previously been treated with a biologic treatment (natural substance that is made by using living cells in a laboratory). This is a Phase 4, randomized, open-label, assessor blinded, active comparator study with 2 Parts. Phase 4 studies test treatments that have already been approved to treat patients with a condition or disease. This study is open-label, which means that both participants and study doctors know which study treatment is given to participants Participants will be administered subcutaneous (SC) treatment of risankizumab every 12 weeks for up to 44 weeks or provided deucravacitinib oral tablets to be taken once daily. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Official title: A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor Blinded Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

393

Start Date

2024-05-10

Completion Date

2026-03

Last Updated

2026-02-24

Healthy Volunteers

Conditions

Moderate Plaque Psoriasis

Interventions

DRUG

Risankizumab

Solution for Subcutaneous (SC) injection

DRUG

Deucravacitinib

Oral tablet

Inclusion Criteria: * Participant with a diagnosis of chronic plaque psoriasis (PsO) with or without psoriatic arthritis, for at least 6 months prior to Baseline. * Stable moderate chronic plaque psoriasis at both Screening and Baseline as defined as: * Body Surface Area (BSA) ≥ 10% and ≤ 15%, * Psoriasis Area and Severity Index (PASI) ≥ 12, and * Static Physician Global Assessment (sPGA) = 3 (moderate) based on a 5-point scale (0 to 4). * Participant must be a candidate for systemic therapy as assessed by the investigator * Psoriasis inadequately controlled by topicals, phototherapy and/or systemic treatments (including, but not limited to, methotrexate, apremilast, cyclosporine A, corticosteroids, and/or cyclophosphamide) Exclusion Criteria: * Participants with any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO). * Participants with a history of current drug-induced PsO or a drug-induced exacerbation of preexisting PsO. * Participants with a history of active ongoing inflammatory skin diseases other than PsO (with or without PsA) that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema). * Participants with a history of severe renal insufficiency defined as creatinine clearance \< 30 mL/min and/or requiring hemodialysis or peritoneal dialysis. * Participantswith a history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months. * Participants with a history of an allergic reaction or significant sensitivity to constituents of the study drugs (and its excipients) and/or other products in the same class. * Participants who have had major surgery performed within 12 weeks prior to randomization or planned during the conduct of the study (e.g., hip replacement, aneurysm removal, stomach ligation). * Participants with evidence of: Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as: * HBV: Hepatitis B surface antigen (HBs Ag) positive (+) test or detected sensitivity on the HBV DNA PCR qualitative test for subjects who are hepatitis B core antibody (HBc Ab) positive (+) (and for hepatitis B surface antibody \[HBs Ab\] positive \[+\] participants where mandated by local requirements). * HCV: HCV RNA detectable in any participant with anti-HCV antibody (HCV Ab). * Human immunodeficiency virus (HIV), defined as confirmed positive anti-HIV Ab test and considered to have unstable disease (Unless meeting criteria for stable disease) Participants with HIV with no history of AIDS-defining conditions AND stable disease for at least 6 months prior to screening can be enrolled. Criteria for stable disease is achieved if all below criteria are met. Documentation of "stable disease" can be done at the Screening visit or by documentation of labs performed within 1 month of the Randomization visit, in addition to the subject's medical history. * On stable antiretroviral therapy; * Viral load (HIV RNA) below the lower limit of quantification by a validated and approved plasma HIV-1 RNA quantitative assay; * CD4+ T cell count ≥ 500 cells/μL. \- Participants with any of the following medical diseases or disorders: * Recent (within past 6 months) cerebrovascular accident or myocardial infarction; * History of an organ transplant which requires continued immunosuppression; * 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. * Prior history of suicide attempt at any time in the subject's lifetime prior to signing the informed consent and randomization, or major depression or suicidal ideation or attempt requiring hospitalization within the last 3 years prior to signing the informed consent. * Hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. \- Participants who received within 30 days prior to Baseline any: * Other systemic immunomodulating treatments (including, but not limited to: e.g., methotrexate, apremilast, cyclosporine A, corticosteroids, cyclophosphamide, tofacitinib \[Xeljanz®\]); * Other systemic PsO treatments (e.g., retinoids, fumarates, any other drug known to possibly benefit PsO); * Photochemotherapy (e.g., PUVA), phototherapy (e.g., UVB) or prolonged exposure or use of tanning booths or ultraviolet light sources. * Participants who received within 14 days prior to Baseline any topical treatment for PsO or any other skin condition (including, but not limited to: e.g., corticosteroids, vitamin D analogues, vitamin A analogues, pimecrolimus, retinoids, salicyl vaseline, salicylic acid, lactic acid, tacrolimus, tar, urea, or anthralin). * Participants who have been treated with any strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin, St. John's Wort) within 30 days or 5 half-lives of start of treatment with deucravacitinib. * Participants who received any live viral or bacterial vaccine within 4 weeks prior to the first dose of study drug, or expect the need for live vaccination during study participation including at least 147 days (21 weeks or as guided by the local risankizumab label \[if approved\], whichever is longer) after the last dose of risankizumab or at least 30 days after the last dose of deucravacitinib. * Participants who have been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study.

Locations (88)

Total Skin and Beauty Dermatology Center /ID# 263011

Birmingham, Alabama, United States

Advanced Research Associates - Glendale /ID# 263621

Glendale, Arizona, United States

Clear Dermatology & Aesthetics Center /ID# 263626

Scottsdale, Arizona, United States

Dermatology Trial Associates /ID# 264480

Bryant, Arkansas, United States

First OC Dermatology /ID# 263003

Fountain Valley, California, United States

Integrative Skin Science and Research /ID# 264504

Sacramento, California, United States

Physioseq, LLC /ID# 265035

Sacramento, California, United States

Medderm Associates Dermatology /ID# 263858

San Diego, California, United States

Southern California Dermatology /ID# 263021

Santa Ana, California, United States

Clearlyderm Dermatology - West Boca /ID# 264963

Boca Raton, Florida, United States

Driven Research /ID# 263002

Coral Gables, Florida, United States

Skin Care Research - Hollywood /ID# 263877

Hollywood, Florida, United States

International Dermatology Research /ID# 264911

Miami, Florida, United States

Lenus Research and Medical Group /ID# 263886

Miami, Florida, United States

Wellness Clinical Research - Miami Lakes /ID# 263887

Miami Lakes, Florida, United States

Skin Care Research - Tampa /ID# 263880

Tampa, Florida, United States

Advanced Clinical Research Institute /ID# 263878

Tampa, Florida, United States

University Dermatology and Vein Clinic, LLC /ID# 263028

Chicago, Illinois, United States

Arlington Dermatology /ID# 263001

Rolling Meadows, Illinois, United States

Dawes Fretzin, LLC /ID# 264578

Indianapolis, Indiana, United States

MetroBoston Clinical Partners /ID# 263860

Boston, Massachusetts, United States

University of Michigan Health System - Ann Arbor /ID# 265233

Ann Arbor, Michigan, United States

Clinical Research Institute of Michigan - Clinton Township Office /ID# 264968

Clinton Township, Michigan, United States

Dermatology and Skin Center of Lees Summit /ID# 263560

Lee's Summit, Missouri, United States

Physician Research Collaboration, LLC /ID# 263568

Lincoln, Nebraska, United States

Skin Cancer and Dermatology Institute - Reno /ID# 263697

Reno, Nevada, United States

StracSkin, PLLC /ID# 263024

Portsmouth, New Hampshire, United States

Oregon Dermatology & Research Center /ID# 263674

Portland, Oregon, United States

Clinical Partners /ID# 263862

Johnston, Rhode Island, United States

Health Concepts /ID# 263016

Rapid City, South Dakota, United States

Arlington Research Center, Inc /ID# 263908

Arlington, Texas, United States

Bellaire Dermatology Associates /ID# 263897

Bellaire, Texas, United States

U.S. Dermatology Partners - Cedar Park /ID# 263906

Cedar Park, Texas, United States

Dermatology Treatment and Research Center /ID# 267071

Dallas, Texas, United States

Texas Dermatology Research Center /ID# 264487

Plano, Texas, United States

Dermatology Clinical Research Center of San Antonio /ID# 263869

San Antonio, Texas, United States

Center for Clinical Studies - Clear Lake /ID# 263009

Webster, Texas, United States

Center for Clinical Studies - Clear Lake /ID# 263917

Webster, Texas, United States

Premier Clinical Research /ID# 263679

Spokane, Washington, United States

Paratus Clinical Research Woden /ID# 263120

Phillip, Australian Capital Territory, Australia

Premier Dermatology /ID# 263119

Kogarah, New South Wales, Australia

The Skin Hospital - Sydney /ID# 263634

Sydney, New South Wales, Australia

Veracity Clinical Research /ID# 263091

Woolloongabba, Queensland, Australia

Skin Health Institute /ID# 263116

Carlton, Victoria, Australia

Sinclair Dermatology - Melbourne /ID# 262997

East Melbourne, Victoria, Australia

Cliniques Universitaires UCL Saint-Luc /ID# 263106

Brussels, Brussels Capital, Belgium

UZ Gent /ID# 263107

Ghent, Oost-Vlaanderen, Belgium

CHU de Liege /ID# 263108

Liège, Belgium

Dermatology Research Institute - Blackfoot Trail /ID# 264476

Calgary, Alberta, Canada

Beacon Dermatology Inc /ID# 264266

Calgary, Alberta, Canada

Wiseman Dermatology Research /ID# 265317

Winnipeg, Manitoba, Canada

Toronto Dermatology Centre /ID# 264273

Toronto, Ontario, Canada

Private Practice - Dr. Kim Papp Clinical Research /ID# 264269

Waterloo, Ontario, Canada

Private Practice - Dr. Angelique Gagne-Henley /ID# 264267

Saint-Jérôme, Quebec, Canada

Universitaetsklinikum Freiburg /ID# 263069

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Hautarztpraxis Langenau /ID# 263070

Langenau, Baden-Wurttemberg, Germany

Beldio Research GmbH /ID# 263073

Memmingen, Bavaria, Germany

Dermatologie Mahlow /ID# 263072

Blankenfelde-Mahlow, Brandenburg, Germany

Fachklinik Bad Bentheim /ID# 263066

Bad Bentheim, Lower Saxony, Germany

Universitaetsklinikum Muenster /ID# 263061

Münster, North Rhine-Westphalia, Germany

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 263955

Berlin, Germany

University General Hospital Attikon /ID# 263421

Athens, Attica, Greece

General Hospital Andreas Syggros /ID# 263418

Athens, Attica, Greece

General Hospital Andreas Syggros /ID# 263708

Athens, Attica, Greece

Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263419

Thessaloniki, Greece

Papageorgiou General Hospital /ID# 263414

Thessaloniki, Greece

Debreceni Egyetem-Klinikai Kozpont /ID# 263484

Debrecen, Hajdú-Bihar, Hungary

Derm-surg /ID# 263799

Kaposvár, Somogy County, Hungary

Semmelweis Egyetem /ID# 263483

Budapest, Hungary

UNO Medical Trials /ID# 263478

Budapest, Hungary

Szegedi Tudomanyegyetem /ID# 263800

Szeged, Hungary

IRCCS Istituto Clinico Humanitas /ID# 263466

Rozzano, Lombardy, Italy

Duplicate_Azienda Ospedaliera Universitaria Federico II /ID# 264034

Naples, Napoli, Italy

IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 263986

Bologna, Italy

Azienda Ospedaliero Universitaria Pisana /ID# 263468

Pisa, Italy

Amsterdam UMC, locatie AMC /ID# 263550

Amsterdam, North Holland, Netherlands

Spaarne Gasthuis - Hoofddorp /ID# 263165

Hoofddorp, North Holland, Netherlands

Private Practice - Dr. Alma Cruz /ID# 263212

Carolina, Puerto Rico

Pan American Center for Oncology Trials /ID# 263206

Rio Piedras, Puerto Rico

Clinical Research Puerto Rico /ID# 263213

San Juan, Puerto Rico

GCM Medical Group, PSC /ID# 263198

San Juan, Puerto Rico

Mindful Medical Research /ID# 263201

San Juan, Puerto Rico

Hospital General Universitario de Alicante Doctor Balmis /ID# 262977

Alicante, Spain

Hospital Clinic de Barcelona /ID# 263040

Barcelona, Spain

Hospital Universitario de La Princesa /ID# 262980

Madrid, Spain

Victoria Hospital /ID# 262984

Kirkcaldy, Fife, United Kingdom

Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262981

London, Greater London, United Kingdom

Northern Care Alliance NHS Group /ID# 262983

Salford, United Kingdom

Clinical Research Directory

A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (88)