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

Status: Active_not_recruiting
Location: See all (88) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Alabama
Total Skin and Beauty Dermatology Center /ID# 263011
Birmingham
Arkansas
Dermatology Trial Associates /ID# 264480
Bryant
Arizona
Advanced Research Associates - Glendale /ID# 263621
Glendale
Clear Dermatology & Aesthetics Center /ID# 263626
Scottsdale
California
First OC Dermatology /ID# 263003
Fountain Valley
Integrative Skin Science and Research /ID# 264504
Sacramento
Physioseq, LLC /ID# 265035
Sacramento
Medderm Associates Dermatology /ID# 263858
San Diego
Southern California Dermatology /ID# 263021
Santa Ana
Florida
Clearlyderm Dermatology - West Boca /ID# 264963
Boca Raton
Driven Research /ID# 263002
Coral Gables
Skin Care Research - Hollywood /ID# 263877
Hollywood
International Dermatology Research /ID# 264911
Miami
Lenus Research and Medical Group /ID# 263886
Miami
Wellness Clinical Research - Miami Lakes /ID# 263887
Miami Lakes
Advanced Clinical Research Institute /ID# 263878
Tampa
Skin Care Research - Tampa /ID# 263880
Tampa
Illinois
University Dermatology and Vein Clinic, LLC /ID# 263028
Chicago
Arlington Dermatology /ID# 263001
Rolling Meadows
Indiana
Dawes Fretzin, LLC /ID# 264578
Indianapolis
Massachusetts
MetroBoston Clinical Partners /ID# 263860
Boston
Michigan
University of Michigan Health System - Ann Arbor /ID# 265233
Ann Arbor
Clinical Research Institute of Michigan - Chesterfield /ID# 264968
Clinton Township
Missouri
Dermatology and Skin Center of Lees Summit /ID# 263560
Lee's Summit
Nebraska
Physician Research Collaboration, LLC /ID# 263568
Lincoln
New Hampshire
ActivMed Practice and Research, LLC /ID# 263024
Portsmouth
Nevada
Skin Cancer and Dermatology Institute - Reno /ID# 263697
Reno
Oregon
Oregon Dermatology & Research Center /ID# 263674
Portland
Rhode Island
Clinical Partners /ID# 263862
Johnston
South Dakota
Health Concepts /ID# 263016
Rapid City
Texas
Arlington Research Center, Inc /ID# 263908
Arlington
Bellaire Dermatology Associates /ID# 263897
Bellaire
U.S. Dermatology Partners - Cedar Park /ID# 263906
Cedar Park
Dermatology Treatment and Research Center /ID# 267071
Dallas
Texas Dermatology Research Center /ID# 264487
Plano
Dermatology Clinical Research Center of San Antonio /ID# 263869
San Antonio
Center for Clinical Studies - Clear Lake /ID# 263009
Webster
Center for Clinical Studies - Clear Lake /ID# 263917
Webster
Washington
Premier Clinical Research /ID# 263679
Spokane
Other Locations
Australia
Skin Health Institute /ID# 263116
Carlton
Sinclair Dermatology - Melbourne /ID# 262997
East Melbourne
Premier Dermatology /ID# 263119
Kogarah
Paratus Clinical Research Woden /ID# 263120
Phillip
The Skin Hospital - Sydney /ID# 263634
Sydney
Veracity Clinical Research /ID# 263091
Woolloongabba
Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 263106
Brussels
UZ Gent /ID# 263107
Ghent
CHU de Liège /ID# 263108
Liège
Canada
Beacon Dermatology Inc /ID# 264266
Calgary
Dermatology Research Institute - Blackfoot Trail /ID# 264476
Calgary
Private Practice - Dr. Angelique Gagne-Henley /ID# 264267
Saint-jérôme
Toronto Dermatology Centre /ID# 264273
Toronto
Private Practice - Dr. Kim Papp Clinical Research /ID# 264269
Waterloo
Wiseman Dermatology Research /ID# 265317
Winnipeg
Germany
Fachklinik Bad Bentheim /ID# 263066
Bad Bentheim
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 263955
Berlin
Dermatologische Gemeinschaftspraxis Mahlow /ID# 263072
Blankenfelde-mahlow
Universitaetsklinikum Freiburg /ID# 263069
Freiburg Im Breisgau
Hautarztpraxis Langenau /ID# 263070
Langenau
Beldio Research GmbH /ID# 263073
Memmingen
Universitaetsklinikum Muenster /ID# 263061
Münster
Greece
General Hospital Andreas Syggros /ID# 263418
Athens
General Hospital Andreas Syggros /ID# 263708
Athens
University General Hospital Attikon /ID# 263421
Athens
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263419
Thessaloniki
Papageorgiou General Hospital /ID# 263414
Thessaloniki
Hungary
Semmelweis Egyetem /ID# 263483
Budapest
UNO Medical Trials /ID# 263478
Budapest
Debreceni Egyetem-Klinikai Kozpont /ID# 263484
Debrecen
Derm-surg /ID# 263799
Kaposvár
Szegedi Tudományegyetem /ID# 263800
Szeged
Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 263986
Bologna
Duplicate_Azienda Ospedaliera Universitaria Federico II /ID# 264034
Naples
Azienda Ospedaliero Universitaria Pisana /ID# 263468
Pisa
IRCCS Istituto Clinico Humanitas /ID# 263466
Rozzano
Netherlands
Amsterdam UMC, locatie AMC /ID# 263550
Amsterdam
Spaarne Gasthuis - Hoofddorp /ID# 263165
Hoofddorp
Puerto Rico
Private Practice - Dr. Alma Cruz /ID# 263212
Carolina
Pan American Center for Oncology Trials /ID# 263206
Rio Piedras
Clinical Research Puerto Rico /ID# 263213
San Juan
GCM Medical Group, PSC /ID# 263198
San Juan
Mindful Medical Research /ID# 263201
San Juan
Spain
Hospital General Universitario de Alicante Doctor Balmis /ID# 262977
Alicante
Hospital Clinic de Barcelona /ID# 263040
Barcelona
Hospital Universitario de La Princesa /ID# 262980
Madrid
United Kingdom
Victoria Hospital /ID# 262984
Kirkcaldy
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262981
London
Northern Care Alliance NHS Group /ID# 262983
Salford
Time Frame
Start Date: 2024-05-10
Completion Date: 2026-03
Participants
Target number of participants: 393
Treatments
Experimental: Period A: Arm 1 Risankizumab Dose A
Participants will be centrally randomized at the Baseline (Day 1) visit to receive Risankizumab as a single SC injection
Experimental: Period A: Arm 2 Deucravacitinib Dose A
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
Experimental: Period B: Arm 2a Risankizumab Dose A (Continued)
Participants initially randomized to risankizumab (Arm 1) will continue to receive risankizumab as a single SC injection at Weeks 16, 28, and 40
Experimental: Period B: Arm 2b Deucravacitinib Dose A
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
Experimental: Period B: Arm 2a Risankizumab Dose A
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
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov