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)

Last updated: January 10, 2025
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

4

Condition

Rosacea

Warts

Rash

Treatment

Risankizumab

Deucravacitinib

Clinical Study ID

NCT06333860
M24-541
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant with a diagnosis of chronic plaque psoriasis (PsO) with or withoutpsoriatic arthritis, for at least 6 months prior to Baseline.

  • Stable moderate chronic plaque psoriasis at both Screening and Baseline as definedas:

  • 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-pointscale (0 to 4).

  • Participant must be a candidate for systemic therapy as assessed by the investigator

  • Psoriasis inadequately controlled by topicals, phototherapy and/or systemictreatments (including, but not limited to, methotrexate, apremilast, cyclosporine A,corticosteroids, and/or cyclophosphamide)

Exclusion

Exclusion Criteria:

  • Participants with any form of PsO other than chronic plaque PsO (e.g., pustular PsO,palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttatePsO).

  • Participants with a history of current drug-induced PsO or a drug-inducedexacerbation of preexisting PsO.

  • Participants with a history of active ongoing inflammatory skin diseases other thanPsO (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 creatinineclearance < 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 toconstituents of the study drugs (and its excipients) and/or other products in thesame class.

  • Participants who have had major surgery performed within 12 weeks prior torandomization 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 sensitivityon 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 testand considered to have unstable disease (Unless meeting criteria for stable disease)Participants with HIV with no history of AIDS-defining conditions AND stable diseasefor at least 6 months prior to screening can be enrolled. Criteria for stabledisease 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 1month 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 andapproved 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 yearsexcept for successfully treated non-melanoma skin cancer (NMSC) or localizedcarcinoma in situ of the cervix.

  • Prior history of suicide attempt at any time in the subject's lifetime prior tosigning the informed consent and randomization, or major depression or suicidalideation or attempt requiring hospitalization within the last 3 years prior tosigning the informed consent.

  • Hereditary problems of galactose intolerance, total lactase deficiency, orglucose-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 topossibly benefit PsO);

  • Photochemotherapy (e.g., PUVA), phototherapy (e.g., UVB) or prolonged exposure oruse of tanning booths or ultraviolet light sources.

  • Participants who received within 14 days prior to Baseline any topicaltreatment 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 enzymeinducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin, St. John'sWort) within 30 days or 5 half-lives of start of treatment withdeucravacitinib.

  • Participants who received any live viral or bacterial vaccine within 4 weeksprior to the first dose of study drug, or expect the need for live vaccinationduring study participation including at least 147 days (21 weeks or as guidedby the local risankizumab label [if approved], whichever is longer) after thelast dose of risankizumab or at least 30 days after the last dose ofdeucravacitinib.

  • Participants who have been treated with any investigational drug within 30 daysor 5 half-lives of the drug (whichever is longer) prior to the first dose ofstudy drug or be currently enrolled in another interventional clinical study.

Study Design

Total Participants: 393
Treatment Group(s): 2
Primary Treatment: Risankizumab
Phase: 4
Study Start date:
May 10, 2024
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Paratus Clinical Research Woden /ID# 263120

    Phillip, Australian Capital Territory 2606
    Australia

    Site Not Available

  • Premier Dermatology /ID# 263119

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • The Skin Hospital - Sydney /ID# 263634

    Sydney, New South Wales 2010
    Australia

    Site Not Available

  • Veracity Clinical Research /ID# 263091

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Skin Health Institute /ID# 263116

    Carlton, Victoria 3053
    Australia

    Site Not Available

  • Sinclair Dermatology - Melbourne /ID# 262997

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Cliniques Universitaires UCL Saint-Luc /ID# 263106

    Woluwe-Saint-Lambert, Bruxelles-Capitale 1200
    Belgium

    Site Not Available

  • CHU de Liège /ID# 263108

    Liège, Liege 4000
    Belgium

    Site Not Available

  • UZ Gent /ID# 263107

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • Beacon Dermatology Inc /ID# 264266

    Calgary, Alberta T3A 2N1
    Canada

    Site Not Available

  • Dermatology Research Institute - Blackfoot Trail /ID# 264476

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Wiseman Dermatology Research /ID# 265317

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Toronto Dermatology Centre /ID# 264273

    Toronto, Ontario M3H 5Y8
    Canada

    Site Not Available

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

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

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

    St-Jérôme, Quebec J7Z 7E2
    Canada

    Site Not Available

  • Universitaetsklinikum Freiburg /ID# 263069

    Freiburg, Baden-Wuerttemberg 79106
    Germany

    Site Not Available

  • Hautarztpraxis Langenau /ID# 263070

    Langenau, Baden-Wuerttemberg 89129
    Germany

    Site Not Available

  • Beldio Research GmbH /ID# 263073

    Memmingen, Bayern 87700
    Germany

    Site Not Available

  • Dermatologische Gemeinschaftspraxis Mahlow /ID# 263072

    Blankenfelde-Mahlow, Brandenburg 15831
    Germany

    Site Not Available

  • Fachklinik Bad Bentheim /ID# 263066

    Bad Bentheim, Niedersachsen 48455
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster /ID# 263061

    Muenster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 263955

    Berlin, 10117
    Germany

    Site Not Available

  • Charité Universitätsmedizin Berlin - Campus Mitte /ID# 263955

    Berlin, 10117
    Germany

    Active - Recruiting

  • General Hospital Andreas Syggros /ID# 263418

    Athens, Attiki 16121
    Greece

    Site Not Available

  • General Hospital Andreas Syggros /ID# 263708

    Athens, Attiki 16121
    Greece

    Site Not Available

  • University General Hospital Attikon /ID# 263421

    Athens, Attiki 12462
    Greece

    Site Not Available

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

    Thessaloniki, 54643
    Greece

    Site Not Available

  • Papageorgiou General Hospital /ID# 263414

    Thessaloniki, 56429
    Greece

    Site Not Available

  • Debreceni Egyetem-Klinikai Kozpont /ID# 263484

    Debrecen, Hajdu-Bihar 4032
    Hungary

    Site Not Available

  • Derm-surg /ID# 263799

    Kaposvár, Somogy 7400
    Hungary

    Site Not Available

  • Semmelweis Egyetem /ID# 263483

    Budapest, 1085
    Hungary

    Site Not Available

  • UNO Medical Trials /ID# 263478

    Budapest, 1135
    Hungary

    Site Not Available

  • Szegedi Tudományegyetem /ID# 263800

    Szeged, 6720
    Hungary

    Site Not Available

  • IRCCS Istituto Clinico Humanitas /ID# 263466

    Rozzano, Lombardia 20089
    Italy

    Site Not Available

  • AOU Federico II di Napoli /ID# 264034

    Naples, Napoli 80131
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II /ID# 264034

    Naples, Napoli 80131
    Italy

    Site Not Available

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

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II /ID# 264034

    Napoli, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana /ID# 263468

    Pisa, 56126
    Italy

    Site Not Available

  • Amsterdam UMC, locatie AMC /ID# 263550

    Amsterdam, Noord-Holland 1105 AZ
    Netherlands

    Site Not Available

  • Spaarne Gasthuis - Hoofddorp /ID# 263165

    Hoofddorp, Noord-Holland 2134 TM
    Netherlands

    Site Not Available

  • Private Practice - Dr. Alma Cruz /ID# 263212

    Carolina, 00985
    Puerto Rico

    Site Not Available

  • Pan American Center for Oncology Trials /ID# 263206

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • Clinical Research Puerto Rico /ID# 263213

    San Juan, 00909-1711
    Puerto Rico

    Site Not Available

  • GCM Medical Group, PSC /ID# 263198

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • Mindful Medical Research /ID# 263201

    San Juan, 00918-3756
    Puerto Rico

    Site Not Available

  • Hospital General Universitario de Alicante Doctor Balmis /ID# 262977

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona /ID# 263040

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitario de La Princesa /ID# 262980

    Madrid, 28006
    Spain

    Site Not Available

  • Victoria Hospital /ID# 262984

    Kirkcaldy, Fife KY2 5AH
    United Kingdom

    Site Not Available

  • Barts Health NHS Trust /ID# 262981

    London, Greater London E1 2ES
    United Kingdom

    Site Not Available

  • Northern Care Alliance NHS Group /ID# 262983

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Total Skin and Beauty Dermatology Center /ID# 263011

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Advanced Research Associates - Glendale /ID# 263621

    Glendale, Arizona 85308
    United States

    Site Not Available

  • Investigate MD /ID# 263626

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Dermatology Trial Associates /ID# 264480

    Bryant, Arkansas 72022
    United States

    Site Not Available

  • First OC Dermatology /ID# 263003

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Integrative Skin Science and Research /ID# 264504

    Sacramento, California 95815
    United States

    Site Not Available

  • Physioseq, LLC /ID# 265035

    Sacramento, California 95825
    United States

    Site Not Available

  • Medderm Associates Dermatology /ID# 263858

    San Diego, California 92103
    United States

    Site Not Available

  • Southern California Dermatology /ID# 263021

    Santa Ana, California 92701
    United States

    Site Not Available

  • Clearlyderm Dermatology - West Boca /ID# 264963

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • Driven Research /ID# 263002

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Skin Care Research - Hollywood /ID# 263877

    Hollywood, Florida 33021-6748
    United States

    Site Not Available

  • International Dermatology Research /ID# 264911

    Miami, Florida 33144
    United States

    Site Not Available

  • Lenus Research and Medical Group /ID# 263886

    Miami, Florida 33172
    United States

    Site Not Available

  • Wellness Clinical Research - Miami Lakes /ID# 263887

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Advanced Clinical Research Institute /ID# 263878

    Tampa, Florida 33607
    United States

    Site Not Available

  • Skin Care Research - Tampa /ID# 263880

    Tampa, Florida 33607-6438
    United States

    Site Not Available

  • University Dermatology and Vein Clinic, LLC /ID# 263028

    Chicago, Illinois 60640-7972
    United States

    Site Not Available

  • Arlington Dermatology /ID# 263001

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Dawes Fretzin, LLC /ID# 264578

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • MetroBoston Clinical Partners /ID# 263860

    Boston, Massachusetts 02135-3511
    United States

    Site Not Available

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

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Clinical Research Institute of Michigan - Chesterfield /ID# 264968

    Clinton Township, Michigan 48038
    United States

    Site Not Available

  • Dermatology and Skin Center of Lees Summit /ID# 263560

    Lee's Summit, Missouri 64064-2301
    United States

    Site Not Available

  • Physician Research Collaboration, LLC /ID# 263568

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Skin Cancer and Dermatology Institute - Reno /ID# 263697

    Reno, Nevada 89509
    United States

    Site Not Available

  • ActivMed Practices & Research - Portsmouth /ID# 263024

    Portsmouth, New Hampshire 03801
    United States

    Active - Recruiting

  • Allcutis Research /ID# 263024

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Oregon Dermatology & Research Center /ID# 263674

    Portland, Oregon 97210
    United States

    Site Not Available

  • Clinical Partners /ID# 263862

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • Health Concepts /ID# 263016

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Arlington Research Center, Inc /ID# 263908

    Arlington, Texas 76011
    United States

    Site Not Available

  • Bellaire Dermatology Associates /ID# 263897

    Bellaire, Texas 77401
    United States

    Site Not Available

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

    Cedar Park, Texas 78613
    United States

    Site Not Available

  • Dermatology Treatment and Research Center /ID# 267071

    Dallas, Texas 75230
    United States

    Site Not Available

  • Texas Dermatology Research Center /ID# 264487

    Plano, Texas 75025
    United States

    Site Not Available

  • Dermatology Clinical Research Center of San Antonio /ID# 263869

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Center for Clinical Studies - Clear Lake /ID# 263009

    Webster, Texas 77598
    United States

    Site Not Available

  • Center for Clinical Studies - Clear Lake /ID# 263917

    Webster, Texas 77598
    United States

    Site Not Available

  • Premier Clinical Research /ID# 263679

    Spokane, Washington 99202
    United States

    Site Not Available

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