Phase
Condition
Rosacea
Warts
Rash
Treatment
Risankizumab
Deucravacitinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Paratus Clinical Research Woden /ID# 263120
Phillip, Australian Capital Territory 2606
AustraliaSite Not Available
Premier Dermatology /ID# 263119
Kogarah, New South Wales 2217
AustraliaSite Not Available
The Skin Hospital - Sydney /ID# 263634
Sydney, New South Wales 2010
AustraliaSite Not Available
Veracity Clinical Research /ID# 263091
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Skin Health Institute /ID# 263116
Carlton, Victoria 3053
AustraliaSite Not Available
Sinclair Dermatology - Melbourne /ID# 262997
East Melbourne, Victoria 3002
AustraliaSite Not Available
Cliniques Universitaires UCL Saint-Luc /ID# 263106
Woluwe-Saint-Lambert, Bruxelles-Capitale 1200
BelgiumSite Not Available
CHU de Liège /ID# 263108
Liège, Liege 4000
BelgiumSite Not Available
UZ Gent /ID# 263107
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
Beacon Dermatology Inc /ID# 264266
Calgary, Alberta T3A 2N1
CanadaSite Not Available
Dermatology Research Institute - Blackfoot Trail /ID# 264476
Calgary, Alberta T2J 7E1
CanadaSite Not Available
Wiseman Dermatology Research /ID# 265317
Winnipeg, Manitoba R3M 3Z4
CanadaSite Not Available
Toronto Dermatology Centre /ID# 264273
Toronto, Ontario M3H 5Y8
CanadaSite Not Available
Private Practice - Dr. Kim Papp Clinical Research /ID# 264269
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
Private Practice - Dr. Angelique Gagne-Henley /ID# 264267
St-Jérôme, Quebec J7Z 7E2
CanadaSite Not Available
Universitaetsklinikum Freiburg /ID# 263069
Freiburg, Baden-Wuerttemberg 79106
GermanySite Not Available
Hautarztpraxis Langenau /ID# 263070
Langenau, Baden-Wuerttemberg 89129
GermanySite Not Available
Beldio Research GmbH /ID# 263073
Memmingen, Bayern 87700
GermanySite Not Available
Dermatologische Gemeinschaftspraxis Mahlow /ID# 263072
Blankenfelde-Mahlow, Brandenburg 15831
GermanySite Not Available
Fachklinik Bad Bentheim /ID# 263066
Bad Bentheim, Niedersachsen 48455
GermanySite Not Available
Universitaetsklinikum Muenster /ID# 263061
Muenster, Nordrhein-Westfalen 48149
GermanySite Not Available
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 263955
Berlin, 10117
GermanySite Not Available
Charité Universitätsmedizin Berlin - Campus Mitte /ID# 263955
Berlin, 10117
GermanyActive - Recruiting
General Hospital Andreas Syggros /ID# 263418
Athens, Attiki 16121
GreeceSite Not Available
General Hospital Andreas Syggros /ID# 263708
Athens, Attiki 16121
GreeceSite Not Available
University General Hospital Attikon /ID# 263421
Athens, Attiki 12462
GreeceSite Not Available
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263419
Thessaloniki, 54643
GreeceSite Not Available
Papageorgiou General Hospital /ID# 263414
Thessaloniki, 56429
GreeceSite Not Available
Debreceni Egyetem-Klinikai Kozpont /ID# 263484
Debrecen, Hajdu-Bihar 4032
HungarySite Not Available
Derm-surg /ID# 263799
Kaposvár, Somogy 7400
HungarySite Not Available
Semmelweis Egyetem /ID# 263483
Budapest, 1085
HungarySite Not Available
UNO Medical Trials /ID# 263478
Budapest, 1135
HungarySite Not Available
Szegedi Tudományegyetem /ID# 263800
Szeged, 6720
HungarySite Not Available
IRCCS Istituto Clinico Humanitas /ID# 263466
Rozzano, Lombardia 20089
ItalySite Not Available
AOU Federico II di Napoli /ID# 264034
Naples, Napoli 80131
ItalySite Not Available
Azienda Ospedaliera Universitaria Federico II /ID# 264034
Naples, Napoli 80131
ItalySite Not Available
IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 263986
Bologna, 40138
ItalySite Not Available
Azienda Ospedaliera Universitaria Federico II /ID# 264034
Napoli, 80131
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana /ID# 263468
Pisa, 56126
ItalySite Not Available
Amsterdam UMC, locatie AMC /ID# 263550
Amsterdam, Noord-Holland 1105 AZ
NetherlandsSite Not Available
Spaarne Gasthuis - Hoofddorp /ID# 263165
Hoofddorp, Noord-Holland 2134 TM
NetherlandsSite Not Available
Private Practice - Dr. Alma Cruz /ID# 263212
Carolina, 00985
Puerto RicoSite Not Available
Pan American Center for Oncology Trials /ID# 263206
Rio Piedras, 00935
Puerto RicoSite Not Available
Clinical Research Puerto Rico /ID# 263213
San Juan, 00909-1711
Puerto RicoSite Not Available
GCM Medical Group, PSC /ID# 263198
San Juan, 00917
Puerto RicoSite Not Available
Mindful Medical Research /ID# 263201
San Juan, 00918-3756
Puerto RicoSite Not Available
Hospital General Universitario de Alicante Doctor Balmis /ID# 262977
Alicante, 03010
SpainSite Not Available
Hospital Clínic de Barcelona /ID# 263040
Barcelona, 08036
SpainSite Not Available
Hospital Universitario de La Princesa /ID# 262980
Madrid, 28006
SpainSite Not Available
Victoria Hospital /ID# 262984
Kirkcaldy, Fife KY2 5AH
United KingdomSite Not Available
Barts Health NHS Trust /ID# 262981
London, Greater London E1 2ES
United KingdomSite Not Available
Northern Care Alliance NHS Group /ID# 262983
Salford, M6 8HD
United KingdomSite Not Available
Total Skin and Beauty Dermatology Center /ID# 263011
Birmingham, Alabama 35205
United StatesSite Not Available
Advanced Research Associates - Glendale /ID# 263621
Glendale, Arizona 85308
United StatesSite Not Available
Investigate MD /ID# 263626
Scottsdale, Arizona 85255
United StatesSite Not Available
Dermatology Trial Associates /ID# 264480
Bryant, Arkansas 72022
United StatesSite Not Available
First OC Dermatology /ID# 263003
Fountain Valley, California 92708
United StatesSite Not Available
Integrative Skin Science and Research /ID# 264504
Sacramento, California 95815
United StatesSite Not Available
Physioseq, LLC /ID# 265035
Sacramento, California 95825
United StatesSite Not Available
Medderm Associates Dermatology /ID# 263858
San Diego, California 92103
United StatesSite Not Available
Southern California Dermatology /ID# 263021
Santa Ana, California 92701
United StatesSite Not Available
Clearlyderm Dermatology - West Boca /ID# 264963
Boca Raton, Florida 33428
United StatesSite Not Available
Driven Research /ID# 263002
Coral Gables, Florida 33134
United StatesSite Not Available
Skin Care Research - Hollywood /ID# 263877
Hollywood, Florida 33021-6748
United StatesSite Not Available
International Dermatology Research /ID# 264911
Miami, Florida 33144
United StatesSite Not Available
Lenus Research and Medical Group /ID# 263886
Miami, Florida 33172
United StatesSite Not Available
Wellness Clinical Research - Miami Lakes /ID# 263887
Miami Lakes, Florida 33016
United StatesSite Not Available
Advanced Clinical Research Institute /ID# 263878
Tampa, Florida 33607
United StatesSite Not Available
Skin Care Research - Tampa /ID# 263880
Tampa, Florida 33607-6438
United StatesSite Not Available
University Dermatology and Vein Clinic, LLC /ID# 263028
Chicago, Illinois 60640-7972
United StatesSite Not Available
Arlington Dermatology /ID# 263001
Rolling Meadows, Illinois 60008
United StatesSite Not Available
Dawes Fretzin, LLC /ID# 264578
Indianapolis, Indiana 46256
United StatesSite Not Available
MetroBoston Clinical Partners /ID# 263860
Boston, Massachusetts 02135-3511
United StatesSite Not Available
University of Michigan Health System - Ann Arbor /ID# 265233
Ann Arbor, Michigan 48109
United StatesSite Not Available
Clinical Research Institute of Michigan - Chesterfield /ID# 264968
Clinton Township, Michigan 48038
United StatesSite Not Available
Dermatology and Skin Center of Lees Summit /ID# 263560
Lee's Summit, Missouri 64064-2301
United StatesSite Not Available
Physician Research Collaboration, LLC /ID# 263568
Lincoln, Nebraska 68516
United StatesSite Not Available
Skin Cancer and Dermatology Institute - Reno /ID# 263697
Reno, Nevada 89509
United StatesSite Not Available
ActivMed Practices & Research - Portsmouth /ID# 263024
Portsmouth, New Hampshire 03801
United StatesActive - Recruiting
Allcutis Research /ID# 263024
Portsmouth, New Hampshire 03801
United StatesSite Not Available
Oregon Dermatology & Research Center /ID# 263674
Portland, Oregon 97210
United StatesSite Not Available
Clinical Partners /ID# 263862
Johnston, Rhode Island 02919
United StatesSite Not Available
Health Concepts /ID# 263016
Rapid City, South Dakota 57702
United StatesSite Not Available
Arlington Research Center, Inc /ID# 263908
Arlington, Texas 76011
United StatesSite Not Available
Bellaire Dermatology Associates /ID# 263897
Bellaire, Texas 77401
United StatesSite Not Available
U.S. Dermatology Partners - Cedar Park /ID# 263906
Cedar Park, Texas 78613
United StatesSite Not Available
Dermatology Treatment and Research Center /ID# 267071
Dallas, Texas 75230
United StatesSite Not Available
Texas Dermatology Research Center /ID# 264487
Plano, Texas 75025
United StatesSite Not Available
Dermatology Clinical Research Center of San Antonio /ID# 263869
San Antonio, Texas 78229
United StatesSite Not Available
Center for Clinical Studies - Clear Lake /ID# 263009
Webster, Texas 77598
United StatesSite Not Available
Center for Clinical Studies - Clear Lake /ID# 263917
Webster, Texas 77598
United StatesSite Not Available
Premier Clinical Research /ID# 263679
Spokane, Washington 99202
United StatesSite Not Available
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