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)

NCT06333860 | Completed Phase 4 FDA Drug

• 2 other identifiers: M24-5412023-509738-20-00
• Study Type: interventional
• Target: 393
• Locations: 12 countries
• Sites: 88

Brief 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.

Conditions

Moderate Plaque Psoriasis

Keywords

risankizumab; deucravacitinib

Outcome Measures

Primary Outcomes (4)

• Period A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90)

  The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. 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.

  At Week 16

• Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Almost Clear) with at least 2-grade improvement from Baseline

  The static Physicians Global Assessment (sPGA) is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; 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.

  Baseline, Week 16

• Period B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) in the Intent to Treat Population for non-responders in Period B (ITT_B_NR).

  The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. 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.

  At Week 52

• Number of Participants Experiencing Adverse Events (AEs)

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.

  Baseline up to 73 Weeks

Secondary Outcomes (4)

• Period A: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100)

  At Week 16

• Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baseline

  Baseline. Week 16

• Period B: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) among participants in the ITT_B_NR Population

  At Week 52

• Period B: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baselineamong participants in the ITT_B_NR Population.

  At Week 52

Study Arms (5)

Period A: Arm 1 Risankizumab Dose A

EXPERIMENTAL

Participants will be centrally randomized at the Baseline (Day 1) visit to receive Risankizumab as a single SC injection

Drug: Risankizumab

Period A: Arm 2 Deucravacitinib Dose A

EXPERIMENTAL

Participants will be centrally randomized at the Baseline (Day 1) visit to receive Deucravacitinib orally once per day until the day prior to Week 16

Drug: Deucravacitinib

Period B: Arm 2a Risankizumab Dose A (Continued)

EXPERIMENTAL

Participants initially randomized to risankizumab (Arm 1) will continue to receive risankizumab as a single SC injection at Weeks 16, 28, and 40

Drug: Risankizumab

Period B: Arm 2b Deucravacitinib Dose A

EXPERIMENTAL

Participants initially randomized to Deucravacitinib (Arm 2) will be re-randomized at the Week 16 visit to receive Deucravacitinib orally once per day up to Week 52

Drug: Deucravacitinib

Period B: Arm 2a Risankizumab Dose A

EXPERIMENTAL

Participants initially randomized to Deucravacitinib (Arm 2) will be re-randomized at the Week 16 visit to receive Risankizumab as a single SC injection at Weeks 16, 20, 32, and 44

Drug: Risankizumab

Interventions

Deucravacitinib DRUG

Oral tablet

Period A: Arm 2 Deucravacitinib Dose A; Period B: Arm 2b Deucravacitinib Dose A

Risankizumab DRUG

Solution for Subcutaneous (SC) injection

Period A: Arm 1 Risankizumab Dose A; Period B: Arm 2a Risankizumab Dose A; Period B: Arm 2a Risankizumab Dose A (Continued)

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (88)

Total Skin and Beauty Dermatology Center /ID# 263011

Birmingham, Alabama, 35205, United States

Location

Advanced Research Associates - Glendale /ID# 263621

Glendale, Arizona, 85308, United States

Location

Clear Dermatology & Aesthetics Center /ID# 263626

Scottsdale, Arizona, 85260, United States

Location

Dermatology Trial Associates /ID# 264480

Bryant, Arkansas, 72022, United States

Location

First OC Dermatology /ID# 263003

Fountain Valley, California, 92708, United States

Location

Integrative Skin Science and Research /ID# 264504

Sacramento, California, 95815, United States

Location

Physioseq, LLC /ID# 265035

Sacramento, California, 95825, United States

Location

Medderm Associates Dermatology /ID# 263858

San Diego, California, 92103, United States

Location

Southern California Dermatology /ID# 263021

Santa Ana, California, 92701, United States

Location

Clearlyderm Dermatology - West Boca /ID# 264963

Boca Raton, Florida, 33428, United States

Location

Driven Research /ID# 263002

Coral Gables, Florida, 33134, United States

Location

Skin Care Research - Hollywood /ID# 263877

Hollywood, Florida, 33021-6748, United States

Location

International Dermatology Research /ID# 264911

Miami, Florida, 33144, United States

Location

Lenus Research and Medical Group /ID# 263886

Miami, Florida, 33172, United States

Location

Wellness Clinical Research - Miami Lakes /ID# 263887

Miami Lakes, Florida, 33016, United States

Location

Skin Care Research - Tampa /ID# 263880

Tampa, Florida, 33607-6438, United States

Location

Advanced Clinical Research Institute /ID# 263878

Tampa, Florida, 33607, United States

Location

University Dermatology and Vein Clinic, LLC /ID# 263028

Chicago, Illinois, 60640-7972, United States

Location

Arlington Dermatology /ID# 263001

Rolling Meadows, Illinois, 60008, United States

Location

Dawes Fretzin, LLC /ID# 264578

Indianapolis, Indiana, 46256, United States

Location

MetroBoston Clinical Partners /ID# 263860

Boston, Massachusetts, 02135-3511, United States

Location

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

Ann Arbor, Michigan, 48109, United States

Location

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

Clinton Township, Michigan, 48038, United States

Location

Dermatology and Skin Center of Lees Summit /ID# 263560

Lee's Summit, Missouri, 64064-2301, United States

Location

Physician Research Collaboration, LLC /ID# 263568

Lincoln, Nebraska, 68516, United States

Location

Skin Cancer and Dermatology Institute - Reno /ID# 263697

Reno, Nevada, 89509, United States

Location

StracSkin, PLLC /ID# 263024

Portsmouth, New Hampshire, 03801, United States

Location

Oregon Dermatology & Research Center /ID# 263674

Portland, Oregon, 97210, United States

Location

Clinical Partners /ID# 263862

Johnston, Rhode Island, 02919, United States

Location

Health Concepts /ID# 263016

Rapid City, South Dakota, 57702, United States

Location

Arlington Research Center, Inc /ID# 263908

Arlington, Texas, 76011, United States

Location

Bellaire Dermatology Associates /ID# 263897

Bellaire, Texas, 77401, United States

Location

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

Cedar Park, Texas, 78613, United States

Location

Dermatology Treatment and Research Center /ID# 267071

Dallas, Texas, 75230, United States

Location

Texas Dermatology Research Center /ID# 264487

Plano, Texas, 75025, United States

Location

Dermatology Clinical Research Center of San Antonio /ID# 263869

San Antonio, Texas, 78229, United States

Location

Center for Clinical Studies - Clear Lake /ID# 263009

Webster, Texas, 77598, United States

Location

Center for Clinical Studies - Clear Lake /ID# 263917

Webster, Texas, 77598, United States

Location

Premier Clinical Research /ID# 263679

Spokane, Washington, 99202, United States

Location

Paratus Clinical Research Woden /ID# 263120

Phillip, Australian Capital Territory, 2606, Australia

Location

Premier Dermatology /ID# 263119

Kogarah, New South Wales, 2217, Australia

Location

The Skin Hospital - Sydney /ID# 263634

Sydney, New South Wales, 2010, Australia

Location

Veracity Clinical Research /ID# 263091

Woolloongabba, Queensland, 4102, Australia

Location

Skin Health Institute /ID# 263116

Carlton, Victoria, 3053, Australia

Location

Sinclair Dermatology - Melbourne /ID# 262997

East Melbourne, Victoria, 3002, Australia

Location

Cliniques Universitaires UCL Saint-Luc /ID# 263106

Brussels, Brussels Capital, 1200, Belgium

Location

UZ Gent /ID# 263107

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

CHU de Liege /ID# 263108

Liège, 4000, Belgium

Location

Dermatology Research Institute - Blackfoot Trail /ID# 264476

Calgary, Alberta, T2J 7E1, Canada

Location

Beacon Dermatology Inc /ID# 264266

Calgary, Alberta, T3A 2N1, Canada

Location

Wiseman Dermatology Research /ID# 265317

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Toronto Dermatology Centre /ID# 264273

Toronto, Ontario, M3H 5Y8, Canada

Location

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

Waterloo, Ontario, N2J 1C4, Canada

Location

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

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

Universitaetsklinikum Freiburg /ID# 263069

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Hautarztpraxis Langenau /ID# 263070

Langenau, Baden-Wurttemberg, 89129, Germany

Location

Beldio Research GmbH /ID# 263073

Memmingen, Bavaria, 87700, Germany

Location

Dermatologie Mahlow /ID# 263072

Blankenfelde-Mahlow, Brandenburg, 15831, Germany

Location

Fachklinik - Bad Bentheim /ID# 263066

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Universitaetsklinikum Muenster /ID# 263061

Münster, North Rhine-Westphalia, 48149, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 263955

Berlin, 10117, Germany

Location

University General Hospital Attikon /ID# 263421

Athens, Attica, 12462, Greece

Location

General Hospital Andreas Syggros /ID# 263418

Athens, Attica, 16121, Greece

Location

General Hospital Andreas Syggros /ID# 263708

Athens, Attica, 16121, Greece

Location

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

Thessaloniki, 54643, Greece

Location

Papageorgiou General Hospital /ID# 263414

Thessaloniki, 56429, Greece

Location

Debreceni Egyetem-Klinikai Kozpont /ID# 263484

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Derm-surg /ID# 263799

Kaposvár, Somogy County, 7400, Hungary

Location

Semmelweis Egyetem /ID# 263483

Budapest, 1085, Hungary

Location

UNO Medical Trials /ID# 263478

Budapest, 1135, Hungary

Location

Szegedi Tudomanyegyetem /ID# 263800

Szeged, 6720, Hungary

Location

IRCCS Istituto Clinico Humanitas /ID# 263466

Rozzano, Lombardy, 20089, Italy

Location

Duplicate_Azienda Ospedaliera Universitaria Federico II /ID# 264034

Naples, Napoli, 80131, Italy

Location

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

Bologna, 40138, Italy

Location

Azienda Ospedaliero Universitaria Pisana /ID# 263468

Pisa, 56126, Italy

Location

Amsterdam UMC, locatie AMC /ID# 263550

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Spaarne Gasthuis - Hoofddorp /ID# 263165

Hoofddorp, North Holland, 2134 TM, Netherlands

Location

Private Practice - Dr. Alma Cruz /ID# 263212

Carolina, 00985, Puerto Rico

Location

Pan American Center for Oncology Trials /ID# 263206

Rio Piedras, 00935, Puerto Rico

Location

Clinical Research Puerto Rico /ID# 263213

San Juan, 00909-1711, Puerto Rico

Location

GCM Medical Group, PSC /ID# 263198

San Juan, 00917, Puerto Rico

Location

Mindful Medical Research /ID# 263201

San Juan, 00918-3756, Puerto Rico

Location

Hospital General Universitario de Alicante Doctor Balmis /ID# 262977

Alicante, 03010, Spain

Location

Hospital Clinic de Barcelona /ID# 263040

Barcelona, 08036, Spain

Location

Hospital Universitario de La Princesa /ID# 262980

Madrid, 28006, Spain

Location

Victoria Hospital /ID# 262984

Kirkcaldy, Fife, KY2 5AH, United Kingdom

Location

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

London, Greater London, E1 2ES, United Kingdom

Location

Northern Care Alliance NHS Group /ID# 262983

Salford, M6 8HD, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Interventions

risankizumab; deucravacitinib

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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 21, 2024
• First Posted: March 27, 2024
• Study Start: May 10, 2024
• Primary Completion: March 19, 2026
• Study Completion: March 19, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

AU (6); BE (3); GR (5); IT (4); CA (6); ES (3); DE (7); US (39); NL (2); PR (5); GB (3); HU (5)