AzTrials
AzTrials

Moderate Plaque PsoriasisPhase 4IMMpactfulNCT06333860

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)

A Phase 4 study testing Risankizumab and Deucravacitinib in people with Moderate Plaque Psoriasis, run by AbbVie at 88 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Moderate Plaque Psoriasis
What is being tested?
Risankizumab and Deucravacitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
393 participants
Where
88 sitesin 12 countries
Study dates
10 May 2024to 19 Mar 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

88 sites in 12 countries.

88 sites in 12 countries

United States39 sites

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

    Ann Arbor, Michigan, 48109

  • Arlington Research Center, Inc /ID# 263908

    Arlington, Texas, 76011

  • Bellaire Dermatology Associates /ID# 263897

    Bellaire, Texas, 77401

  • Total Skin and Beauty Dermatology Center /ID# 263011

    Birmingham, Alabama, 35205

  • Clearlyderm Dermatology - West Boca /ID# 264963

    Boca Raton, Florida, 33428

  • MetroBoston Clinical Partners /ID# 263860

    Boston, Massachusetts, 02135-3511

  • Dermatology Trial Associates /ID# 264480

    Bryant, Arkansas, 72022

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

    Cedar Park, Texas, 78613

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

    Chicago, Illinois, 60640-7972

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

    Clinton Township, Michigan, 48038

  • Driven Research /ID# 263002

    Coral Gables, Florida, 33134

  • Dermatology Treatment and Research Center /ID# 267071

    Dallas, Texas, 75230

  • First OC Dermatology /ID# 263003

    Fountain Valley, California, 92708

  • Advanced Research Associates - Glendale /ID# 263621

    Glendale, Arizona, 85308

  • Skin Care Research - Hollywood /ID# 263877

    Hollywood, Florida, 33021-6748

  • Dawes Fretzin, LLC /ID# 264578

    Indianapolis, Indiana, 46256

  • Clinical Partners /ID# 263862

    Johnston, Rhode Island, 02919

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

    Lee's Summit, Missouri, 64064-2301

  • Physician Research Collaboration, LLC /ID# 263568

    Lincoln, Nebraska, 68516

  • International Dermatology Research /ID# 264911

    Miami, Florida, 33144

  • Lenus Research and Medical Group /ID# 263886

    Miami, Florida, 33172

  • Wellness Clinical Research - Miami Lakes /ID# 263887

    Miami Lakes, Florida, 33016

  • Texas Dermatology Research Center /ID# 264487

    Plano, Texas, 75025

  • Oregon Dermatology & Research Center /ID# 263674

    Portland, Oregon, 97210

  • StracSkin, PLLC /ID# 263024

    Portsmouth, New Hampshire, 03801

  • Health Concepts /ID# 263016

    Rapid City, South Dakota, 57702

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

    Reno, Nevada, 89509

  • Arlington Dermatology /ID# 263001

    Rolling Meadows, Illinois, 60008

  • Integrative Skin Science and Research /ID# 264504

    Sacramento, California, 95815

  • Physioseq, LLC /ID# 265035

    Sacramento, California, 95825

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

    San Antonio, Texas, 78229

  • Medderm Associates Dermatology /ID# 263858

    San Diego, California, 92103

  • Southern California Dermatology /ID# 263021

    Santa Ana, California, 92701

  • Clear Dermatology & Aesthetics Center /ID# 263626

    Scottsdale, Arizona, 85260

  • Premier Clinical Research /ID# 263679

    Spokane, Washington, 99202

  • Skin Care Research - Tampa /ID# 263880

    Tampa, Florida, 33607-6438

  • Advanced Clinical Research Institute /ID# 263878

    Tampa, Florida, 33607

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

    Webster, Texas, 77598

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

    Webster, Texas, 77598

Other trials in United States

Germany7 sites

  • Fachklinik - Bad Bentheim /ID# 263066

    Bad Bentheim, Lower Saxony, 48455

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 263955

    Berlin, 10117

  • Dermatologie Mahlow /ID# 263072

    Blankenfelde-Mahlow, Brandenburg, 15831

  • Universitaetsklinikum Freiburg /ID# 263069

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Hautarztpraxis Langenau /ID# 263070

    Langenau, Baden-Wurttemberg, 89129

  • Beldio Research GmbH /ID# 263073

    Memmingen, Bavaria, 87700

  • Universitaetsklinikum Muenster /ID# 263061

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Australia6 sites

  • Skin Health Institute /ID# 263116

    Carlton, Victoria, 3053

  • Sinclair Dermatology - Melbourne /ID# 262997

    East Melbourne, Victoria, 3002

  • Premier Dermatology /ID# 263119

    Kogarah, New South Wales, 2217

  • Paratus Clinical Research Woden /ID# 263120

    Phillip, Australian Capital Territory, 2606

  • The Skin Hospital - Sydney /ID# 263634

    Sydney, New South Wales, 2010

  • Veracity Clinical Research /ID# 263091

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada6 sites

  • Dermatology Research Institute - Blackfoot Trail /ID# 264476

    Calgary, Alberta, T2J 7E1

  • Beacon Dermatology Inc /ID# 264266

    Calgary, Alberta, T3A 2N1

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

    Saint-Jérôme, Quebec, J7Z 7E2

  • Toronto Dermatology Centre /ID# 264273

    Toronto, Ontario, M3H 5Y8

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

    Waterloo, Ontario, N2J 1C4

  • Wiseman Dermatology Research /ID# 265317

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Greece5 sites

  • University General Hospital Attikon /ID# 263421

    Athens, Attica, 12462

  • General Hospital Andreas Syggros /ID# 263418

    Athens, Attica, 16121

  • General Hospital Andreas Syggros /ID# 263708

    Athens, Attica, 16121

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

    Thessaloniki, 54643

  • Papageorgiou General Hospital /ID# 263414

    Thessaloniki, 56429

Other trials in Greece

Hungary5 sites

  • Semmelweis Egyetem /ID# 263483

    Budapest, 1085

  • UNO Medical Trials /ID# 263478

    Budapest, 1135

  • Debreceni Egyetem-Klinikai Kozpont /ID# 263484

    Debrecen, Hajdú-Bihar, 4032

  • Derm-surg /ID# 263799

    Kaposvár, Somogy County, 7400

  • Szegedi Tudomanyegyetem /ID# 263800

    Szeged, 6720

Other trials in Hungary

Puerto Rico5 sites

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

    Carolina, 00985

  • Pan American Center for Oncology Trials /ID# 263206

    Rio Piedras, 00935

  • Clinical Research Puerto Rico /ID# 263213

    San Juan, 00909-1711

  • GCM Medical Group, PSC /ID# 263198

    San Juan, 00917

  • Mindful Medical Research /ID# 263201

    San Juan, 00918-3756

Other trials in Puerto Rico

Italy4 sites

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

    Bologna, 40138

  • Duplicate_Azienda Ospedaliera Universitaria Federico II /ID# 264034

    Naples, Napoli, 80131

  • Azienda Ospedaliero Universitaria Pisana /ID# 263468

    Pisa, 56126

  • IRCCS Istituto Clinico Humanitas /ID# 263466

    Rozzano, Lombardy, 20089

Other trials in Italy

Belgium3 sites

  • Cliniques Universitaires UCL Saint-Luc /ID# 263106

    Brussels, Brussels Capital, 1200

  • UZ Gent /ID# 263107

    Ghent, Oost-Vlaanderen, 9000

  • CHU de Liege /ID# 263108

    Liège, 4000

Other trials in Belgium

Spain3 sites

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

    Alicante, 03010

  • Hospital Clinic de Barcelona /ID# 263040

    Barcelona, 08036

  • Hospital Universitario de La Princesa /ID# 262980

    Madrid, 28006

Other trials in Spain

United Kingdom3 sites

  • Victoria Hospital /ID# 262984

    Kirkcaldy, Fife, KY2 5AH

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

    London, Greater London, E1 2ES

  • Northern Care Alliance NHS Group /ID# 262983

    Salford, M6 8HD

Other trials in United Kingdom

Netherlands2 sites

  • Amsterdam UMC, locatie AMC /ID# 263550

    Amsterdam, North Holland, 1105 AZ

  • Spaarne Gasthuis - Hoofddorp /ID# 263165

    Hoofddorp, North Holland, 2134 TM

Other trials in Netherlands

About this study

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

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

Read more

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.

Being tested
Risankizumab, Deucravacitinib
Keywords
risankizumab, deucravacitinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RisankizumabDrug

    Solution for Subcutaneous (SC) injection

  • DeucravacitinibDrug

    Oral tablet

Study groups in NCT06333860
Study groupRoleWhat they receive
Period A: Arm 1 Risankizumab Dose AExperimentalParticipants will be centrally randomized at the Baseline (Day 1) visit to receive Risankizumab as a single SC injection
Receives: Drug: Risankizumab
Period A: Arm 2 Deucravacitinib Dose AExperimentalParticipants will be centrally randomized at the Baseline (Day 1) visit to receive Deucravacitinib orally once per day until the day prior to Week 16
Receives: Drug: Deucravacitinib
Period B: Arm 2a Risankizumab Dose A (Continued)ExperimentalParticipants initially randomized to risankizumab (Arm 1) will continue to receive risankizumab as a single SC injection at Weeks 16, 28, and 40
Receives: Drug: Risankizumab
Period B: Arm 2b Deucravacitinib Dose AExperimentalParticipants 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
Receives: Drug: Deucravacitinib
Period B: Arm 2a Risankizumab Dose AExperimentalParticipants 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
Receives: Drug: Risankizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At Week 16

  2. 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.

    Measured: Baseline, Week 16

  3. 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.

    Measured: At Week 52

  4. 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.

    Measured: Baseline up to 73 Weeks

Secondary outcomes (4)

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

    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 100 is defined as at least a 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.

    Measured: At Week 16

  2. Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 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.

    Measured: Baseline. Week 16

  3. 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

    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 100 is defined as at least a 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.

    Measured: At Week 52

  4. 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.

    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.

    Measured: At Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2024
  2. Study start10 May 2024
  3. Primary completion19 Mar 2026
  4. Study completion19 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
393 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06333860
Sponsor's protocol ID
M24-541
Other IDs
2023-509738-20-00, 2023
Acronym
IMMpactful
Status last verified
Apr 2026
First submitted
21 Mar 2024
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Publications

  • Magnolo N, Soung J, Frew J, Costanzo A, Ruiz-Santiago H, Eyerich K, Llamas-Velasco M, Bukhalo M, Sivamani RK, Moore A, Wu T, Xie J, Patel M, Ashley D, Kaplan B, Stakias V, Espaillat R, Warren RB. Risankizumab versus Deucravacitinib in Adults With Moderate Plaque Psoriasis: 16-Week Results from the Phase 4 IMMpactful Trial. Dermatol Ther (Heidelb). 2026 Jul;16(7):3415-3429. doi: 10.1007/s13555-026-01779-x. Epub 2026 May 17.

    PubMed 42143644

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Risankizumab and Deucravacitinib in people with Moderate Plaque Psoriasis, run by AbbVie at 88 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Germany, Australia, Canada, Greece and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Period A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) (time frame: At Week 16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06333860, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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