Clinical trial NCT06333860: 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)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Moderate Plaque Psoriasis
Keywords: risankizumab
deucravacitinib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-03-27
Enrollment: 393
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Period A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90)
timeFrame: At Week 16
measure: 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
timeFrame: Baseline, Week 16
measure: 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).
timeFrame: At Week 52
Secondary outcomes:
measure: Period A: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100)
timeFrame: At Week 16
measure: Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baseline
timeFrame: Baseline. Week 16
measure: 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
timeFrame: At Week 52
measure: 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.
timeFrame: At Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center /ID# 263011
state: Alabama
city: Glendale
country: United States
facility: Advanced Research Associates - Glendale /ID# 263621
state: Arizona
city: Scottsdale
country: United States
facility: Investigate MD /ID# 263626
state: Arizona
city: Bryant
country: United States
facility: Dermatology Trial Associates /ID# 264480
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology /ID# 263003
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research /ID# 264504
state: California
city: Sacramento
country: United States
facility: Physioseq, LLC /ID# 265035
state: California
city: San Diego
country: United States
facility: Medderm Associates Dermatology /ID# 263858
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology /ID# 263021
state: California
city: Boca Raton
country: United States
facility: Clearlyderm Dermatology - West Boca /ID# 264963
state: Florida
city: Coral Gables
country: United States
facility: Driven Research /ID# 263002
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research - Hollywood /ID# 263877
state: Florida
city: Miami Lakes
country: United States
facility: Wellness Clinical Research - Miami Lakes /ID# 263887
state: Florida
city: Miami
country: United States
facility: International Dermatology Research /ID# 264911
state: Florida
city: Miami
country: United States
facility: Lenus Research and Medical Group /ID# 263886
state: Florida
city: Tampa
country: United States
facility: Skin Care Research - Tampa /ID# 263880
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute /ID# 263878
state: Florida
city: Chicago
country: United States
facility: University Dermatology and Vein Clinic, LLC /ID# 263028
state: Illinois
city: Rolling Meadows
country: United States
facility: Arlington Dermatology /ID# 263001
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin, LLC /ID# 264578
state: Indiana
city: Boston
country: United States
facility: MetroBoston Clinical Partners /ID# 263860
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System - Ann Arbor /ID# 265233
state: Michigan
city: Clinton Township
country: United States
facility: Clinical Research Institute of Michigan - Chesterfield /ID# 264968
state: Michigan
city: Lee's Summit
country: United States
facility: Dermatology and Skin Center of Lees Summit /ID# 263560
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC /ID# 263568
state: Nebraska
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute - Reno /ID# 263697
state: Nevada
city: Portsmouth
country: United States
facility: Allcutis Research /ID# 263024
state: New Hampshire
city: Portland
country: United States
facility: Oregon Dermatology & Research Center /ID# 263674
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners /ID# 263862
state: Rhode Island
city: Rapid City
country: United States
facility: Health Concepts /ID# 263016
state: South Dakota
city: Arlington
country: United States
facility: Arlington Research Center, Inc /ID# 263908
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates /ID# 263897
state: Texas
city: Cedar Park
country: United States
facility: U.S. Dermatology Partners - Cedar Park /ID# 263906
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center /ID# 267071
state: Texas
city: Plano
country: United States
facility: Texas Dermatology Research Center /ID# 264487
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio /ID# 263869
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies - Clear Lake /ID# 263009
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies - Clear Lake /ID# 263917
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research /ID# 263679
state: Washington
city: Phillip
country: Australia
facility: Paratus Clinical Research Woden /ID# 263120
state: Australian Capital Territory
city: Kogarah
country: Australia
facility: Premier Dermatology /ID# 263119
state: New South Wales
city: Sydney
country: Australia
facility: The Skin Hospital - Sydney /ID# 263634
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research /ID# 263091
state: Queensland
city: Carlton
country: Australia
facility: Skin Health Institute /ID# 263116
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology - Melbourne /ID# 262997
state: Victoria
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 263106
state: Bruxelles-Capitale
city: Liège
country: Belgium
facility: CHU de Liège /ID# 263108
state: Liege
city: Gent
country: Belgium
facility: UZ Gent /ID# 263107
state: Oost-Vlaanderen
city: Calgary
country: Canada
facility: Dermatology Research Institute - Blackfoot Trail /ID# 264476
state: Alberta
city: Calgary
country: Canada
facility: Beacon Dermatology Inc /ID# 264266
state: Alberta
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research /ID# 265317
state: Manitoba
city: Toronto
country: Canada
facility: Toronto Dermatology Centre /ID# 264273
state: Ontario
city: Waterloo
country: Canada
facility: Private Practice - Dr. Kim Papp Clinical Research /ID# 264269
state: Ontario
city: St-Jérôme
country: Canada
facility: Private Practice - Dr. Angelique Gagne-Henley /ID# 264267
state: Quebec
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg /ID# 263069
state: Baden-Wuerttemberg
city: Langenau
country: Germany
facility: Hautarztpraxis Langenau /ID# 263070
state: Baden-Wuerttemberg
city: Memmingen
country: Germany
facility: Beldio Research GmbH /ID# 263073
state: Bayern
city: Blankenfelde-Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 263072
state: Brandenburg
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim /ID# 263066
state: Niedersachsen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster /ID# 263061
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 263955
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 263421
state: Attiki
city: Athens
country: Greece
facility: General Hospital Andreas Syggros /ID# 263418
state: Attiki
city: Athens
country: Greece
facility: General Hospital Andreas Syggros /ID# 263708
state: Attiki
city: Thessaloniki
country: Greece
facility: Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263419
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital /ID# 263414
city: Debrecen
country: Hungary
facility: Debreceni Egyetem-Klinikai Kozpont /ID# 263484
state: Hajdu-Bihar
city: Kaposvár
country: Hungary
facility: Derm-surg /ID# 263799
state: Somogy
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 263483
city: Budapest
country: Hungary
facility: UNO Medical Trials /ID# 263478
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem /ID# 263800
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas /ID# 263466
state: Lombardia
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II /ID# 264034
state: Napoli
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 263986
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana /ID# 263468
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC /ID# 263550
state: Noord-Holland
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis - Hoofddorp /ID# 263165
state: Noord-Holland
city: Carolina
country: Puerto Rico
facility: Private Practice - Dr. Alma Cruz /ID# 263212
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials /ID# 263206
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico /ID# 263213
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC /ID# 263198
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research /ID# 263201
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante Doctor Balmis /ID# 262977
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona /ID# 263040
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa /ID# 262980
city: Kirkcaldy
country: United Kingdom
facility: Victoria Hospital /ID# 262984
state: Fife
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 262981
state: Greater London
city: Salford
country: United Kingdom
facility: Northern Care Alliance NHS Group /ID# 262983
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: