Phase
Condition
Warts
Rosacea
Rash
Treatment
Placebo
Tildrakizumab 100 mg
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ability to understand the purpose and risks of the trial, willingness and ability tocomply with the protocol, and provide written informed consent in accordance withinstitutional and regulatory guidelines
Age ≥ 18 years of age at the time of signing consent
Diagnosis of moderate to severe psoriasis of the genital area at Screening andbaseline defined as modified sPGA-G score of ≥3.
Presence of non-genital plaque psoriasis (BSA ≥1%) at both Screening and Baseline.
Presence of psoriasis of the genital area that is inadequately controlled withtopical therapy or the subject is intolerant to topical therapy
Negative evaluation for TB within 4 weeks before initiating IMP, defined as anegative QuantiFERON test. Subjects with a positive QuantiFERON test or 2 successiveindeterminate
QuantiFERON tests are allowed if they have all of the following:
no history of active tuberculosis (TB) or symptoms of TB,
a posteroanterior chest radiograph (with associated report available at the site)performed within 3 months of Screening with no evidence of active TB ( or of anyother pulmonary infectious diseases),
if prior latent TB infection, must have history of adequate prophylaxis (per localstandard of care),
if presence of latent TB is established, then treatment according to local countryguidelines must have been followed for 4 weeks, prior to dosing in the study atVisit 2-Week 0.
A maximum of 2 QuantiFERON tests of no more than 3 weeks apart are allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used
Exclusion
Exclusion Criteria:
Predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis,predominantly pustular psoriasis, medication-induced or medication-exacerbatedpsoriasis, or new-onset guttate psoriasis.
Planned surgical intervention between Baseline and the Week 16 evaluation for apre-treatment condition.
Active infection or history of infections as follows:
any active infection (bacterial, fungal or viral) for which systemicanti-infectives were used within 28 days prior to first investigationalmedicinal product (IMP) dose, with the last dose having been received within 7days of Screening,
a serious infection, defined as requiring hospitalization or intravenous (IV)anti-infectives within 8 weeks prior to the first IMP dose, with the last dosehaving been received within 7 days of Screening,
recurrent or chronic infections, e.g., chronic pyelonephritis, chronicosteomyelitis, bronchiectasis, or other active infection that, in the opinionof the Investigator, might cause participation in this study to be detrimentalto the subject.
- Any concurrent medical condition or uncontrolled, clinically significant systemicdisease ( e.g., renal failure, heart failure, hypertension, liver disease, diabetes,or anemia) that, in the opinion of the Investigator, could jeopardize subject safetyor compliance with the protocol.
Study Design
Connect with a study center
MC Medconsult-Lovech
Lovech, 5500
BulgariaSite Not Available
MC Medconsult-Lovech
Lovech 729559, 5500
BulgariaSite Not Available
Medconsult Pleven
Pleven, 5800
BulgariaSite Not Available
Medconsult Pleven
Pleven 728203, 5800
BulgariaSite Not Available
Diagnostic Consulatative Center
Sofia, 1528
BulgariaSite Not Available
Medical Centre Regina Life Clinic
Sofia, 1463
BulgariaSite Not Available
UMHAT Tsaritsa Yoanna-ISUL
Sofia, 1527
BulgariaSite Not Available
Diagnostic Consulatative Center
Sofia 727011, 1528
BulgariaSite Not Available
Medical Centre Regina Life Clinic
Sofia 727011, 1463
BulgariaSite Not Available
UMHAT Tsaritsa Yoanna-ISUL
Sofia 727011, 1527
BulgariaSite Not Available
Aversi Clinic
Tbilisi, 160
GeorgiaActive - Recruiting
David Abuladze Clinic (DAC)
Tbilisi, 179
GeorgiaSite Not Available
JSC Curatio
Tbilisi, 144
GeorgiaActive - Recruiting
New Vision Univestiry Hospital
Tbilisi, 159
GeorgiaActive - Recruiting
Raymann
Tbilisi, 186
GeorgiaActive - Recruiting
Aversi Clinic
Tbilisi 611717, 160
GeorgiaSite Not Available
David Abuladze Clinic (DAC)
Tbilisi 611717, 179
GeorgiaSite Not Available
JSC Curatio
Tbilisi 611717, 144
GeorgiaSite Not Available
New Vision Univestiry Hospital
Tbilisi 611717, 159
GeorgiaSite Not Available
Raymann
Tbilisi 611717, 186
GeorgiaSite Not Available
University of Debrecen Dept of Dermatology
Debrecen, Hajdu-Bihar H-4032
HungarySite Not Available
University of Debrecen Dept of Dermatology
Debrecen 721472, Hajdú-Bihar 720293 H-4032
HungarySite Not Available
Allergo-Derm Bakos Kft
Baross U 20., 5000
HungarySite Not Available
Niepubliczny Zakladu Opieki Zdrowotnej MultiMedica s.c.
Wroclaw, Dolnoslaskie 51-503
PolandSite Not Available
Niepubliczny Zakladu Opieki Zdrowotnej MultiMedica s.c.
Wroclaw 3081368, Lower Silesian Voivodeship 3337492 51-503
PolandSite Not Available
Luxderm Specjalistyczny Gabinet Dermatologiczny
Lublin, Lubslskie 20-573
PolandSite Not Available
Luxderm Specjalistyczny Gabinet Dermatologiczny
Lublin 765876, Lubslskie 20-573
PolandSite Not Available
Centrum Medyczne \All-Med\ spolka komandytowa
Krakow, Malopolska 30-033
PolandSite Not Available
Centrum Medyczne \All-Med\ spolka komandytowa
Krakow 3094802, Malopolska 30-033
PolandSite Not Available
Uniwersytecki Szpital Kliniczny, Klinika Dermatologii
Rzeszw, Podkarpackie Voivodeship 858788 35-055
PolandSite Not Available
Miejski Szpital Zespolony
Gdynia, Pomorskie 81-415
PolandSite Not Available
"Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o"
Malbork, Warmian-Masurian Voivodeship 858791 82-200
PolandSite Not Available
Zdrowie Osteo-Medic s.c.
Bialystok-Podlaskie, 15-351
PolandSite Not Available
Care Access Gdansk
Gdansk, 80-546
PolandSite Not Available
Care Access Gdansk
Gdansk 3099434, 80-546
PolandSite Not Available
Care Access Holsamed Katowice
Katowice, 40-600
PolandSite Not Available
Care Access Holsamed Katowice
Katowice 3096472, 40-600
PolandSite Not Available
Lidia Rajzer-Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny
Krakow, 30-438
PolandActive - Recruiting
Lidia Rajzer-Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny
Krakow 3094802, 30-438
PolandSite Not Available
Clinical Best Solution Sp. z o.o Sp. k. w Lublinie
Lublin, 20-011
PolandActive - Recruiting
Clinical Best Solution Sp. z o.o Sp. k. w Lublinie
Lublin 765876, 20-011
PolandSite Not Available
Clinical Best Solutions SP. Z.O.O. SP.K.
Warsaw, 00-710
PolandSite Not Available
Clinical Best Solutions SP. Z.O.O. SP.K.
Warsaw 756135, 00-710
PolandSite Not Available
Klinika Ambroziak
Warszswa, 02-953
PolandSite Not Available
Medical Dermatology Specialists
Phoenix, Arizona 85006
United StatesSite Not Available
Medical Dermatology Specialists
Phoenix 5308655, Arizona 5551752 85006
United StatesSite Not Available
Smary Cures Clinical Research
Anaheim, California 92806
United StatesSite Not Available
California Dermatology & Clinical Research Institute
Encinitas, California 92024
United StatesSite Not Available
T. Joseph Raoof MD, Inc./Encino Research Center
Encino, California 91436
United StatesSite Not Available
First OC Dermatology Research, Inc
Fountain Valley, California 92708
United StatesSite Not Available
Center for Dermatology Clinical Research, Inc
Fremont, California 94538
United StatesSite Not Available
Dermatology Research Associates
Los Angeles, California 90045
United StatesSite Not Available
LA Universal Research Center Inc, Suite 1
Los Angeles, California 90057
United StatesActive - Recruiting
Amicis Research Center
Northridge, California 91324
United StatesSite Not Available
Therapeutics Clinical Research
San Diego, California 92123
United StatesSite Not Available
Dermatology Institute and Skin Care Center, Inc. DBA Clinical Science Institute
Santa Monica, California 90404
United StatesSite Not Available
Smary Cures Clinical Research
Anaheim 5323810, California 5332921 92806
United StatesSite Not Available
California Dermatology & Clinical Research Institute
Encinitas 5346646, California 5332921 92024
United StatesSite Not Available
T. Joseph Raoof MD, Inc./Encino Research Center
Encino 5346649, California 5332921 91436
United StatesSite Not Available
Center for Dermatology Clinical Research, Inc
Fremont 5350734, California 5332921 94538
United StatesSite Not Available
Dermatology Research Associates
Los Angeles 5368361, California 5332921 90045
United StatesSite Not Available
LA Universal Research Center Inc, Suite 1
Los Angeles 5368361, California 5332921 90057
United StatesSite Not Available
Amicis Research Center
Northridge 5377985, California 5332921 91324
United StatesSite Not Available
Therapeutics Clinical Research
San Diego 5391811, California 5332921 92123
United StatesSite Not Available
Dermatology Institute and Skin Care Center, Inc. DBA Clinical Science Institute
Santa Monica 5393212, California 5332921 90404
United StatesSite Not Available
Paradigm Clinical Research
Wheat Ridge, Colorado 80033
United StatesSite Not Available
Paradigm Clinical Research
Wheat Ridge 5443948, Colorado 5417618 80033
United StatesSite Not Available
Coral Gables Dermatology & Aesthetics
Coral Gables, Florida 33134
United StatesActive - Recruiting
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida 33134
United StatesSite Not Available
Superior Associates in Research, LLC
Hialeah, Florida 33012
United StatesSite Not Available
Homestead Associates in Research Inc
Homestead, Florida 33033
United StatesSite Not Available
Genomics Medical Research
Miami, Florida 33157
United StatesActive - Recruiting
Med-Care Research
Miami, Florida 33165
United StatesSite Not Available
Coral Gables Dermatology & Aesthetics
Coral Gables 4151871, Florida 4155751 33134
United StatesSite Not Available
Florida Academic Centers Research and Education, LLC
Coral Gables 4151871, Florida 4155751 33134
United StatesSite Not Available
Homestead Associates in Research Inc
Homestead 4159050, Florida 4155751 33033
United StatesSite Not Available
Genomics Medical Research
Miami 4164138, Florida 4155751 33157
United StatesSite Not Available
Med-Care Research
Miami 4164138, Florida 4155751 33165
United StatesSite Not Available
Dermatology Affiliates Research Institute, LLC
Atlanta, Georgia 30305
United StatesSite Not Available
Javara Inc. / Privia Medical Group Georgia, LLC
Fayetteville, Georgia 30214
United StatesSite Not Available
Mcintosh Clinic, PC
Thomasville, Georgia 31792
United StatesSite Not Available
Dermatology Affiliates Research Institute, LLC
Atlanta 4180439, Georgia 4197000 30305
United StatesSite Not Available
Mcintosh Clinic, PC
Thomasville 4226348, Georgia 4197000 31792
United StatesSite Not Available
The Indiana Clinical Trials Center
Plainfield, Indiana 46168
United StatesSite Not Available
The Indiana Clinical Trials Center
Plainfield 4263108, Indiana 4921868 46168
United StatesSite Not Available
Oakland Hills Dermatology PC
Auburn Hills, Michigan 48326
United StatesSite Not Available
The Derm Institute of West Michigan
Caledonia, Michigan 49316
United StatesSite Not Available
Hamzavi Dermatology
Fort Gratiot, Michigan 48059-3526
United StatesSite Not Available
Oakland Hills Dermatology PC
Auburn Hills 4984565, Michigan 5001836 48326
United StatesSite Not Available
The Derm Institute of West Michigan
Caledonia 4987661, Michigan 5001836 49316
United StatesSite Not Available
Central Missouri Dermatology Research, LLC
Columbia Falls, Montana 65201
United StatesSite Not Available
Skin Specialists, PC
Omaha, Nebraska 68144
United StatesSite Not Available
Skin Specialists, PC
Omaha 5074472, Nebraska 5073708 68144
United StatesSite Not Available
Forest Hills Dermatology
Kew Gardens, New York 11415
United StatesSite Not Available
Equity Medical
New York, New York 10023
United StatesSite Not Available
Forest Hills Dermatology
Kew Gardens 5123344, New York 5128638 11415
United StatesSite Not Available
Equity Medical
New York 5128581, New York 5128638 10023
United StatesSite Not Available
The Moses H. Cone Memorial Hospital Operating Corporation
Greensboro, North Carolina 27401
United StatesSite Not Available
Hickory Dermatology Research Center, LLC
Hickory, North Carolina 28602
United StatesSite Not Available
Javara Inc/ Tryon Medical Partners, PLLC
Matthews, North Carolina 28105
United StatesSite Not Available
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27104
United StatesSite Not Available
The Moses H. Cone Memorial Hospital Operating Corporation
Greensboro 4469146, North Carolina 4482348 27401
United StatesSite Not Available
Hickory Dermatology Research Center, LLC
Hickory 4470778, North Carolina 4482348 28602
United StatesSite Not Available
Javara Inc/ Tryon Medical Partners, PLLC
Matthews 4478334, North Carolina 4482348 28105
United StatesSite Not Available
Wake Forest University Health Sciences
Winston-Salem 4499612, North Carolina 4482348 27104
United StatesSite Not Available
Bexley Dermatology Research
Bexley, Ohio 43209
United StatesSite Not Available
The Indiana Clinical Trials Center Optima Research Boardman
Boardman, Ohio 44512
United StatesSite Not Available
Wright State Physicians
Fairborn, Ohio 45324
United StatesSite Not Available
The Indiana Clinical Trials Center Optima Research Boardman
Boardman 5147784, Ohio 5165418 44512
United StatesSite Not Available
Oregon Medical Research Center
Portland, Oregon 97201
United StatesSite Not Available
Oregon Medical Research Center
Portland 5746545, Oregon 5744337 97201
United StatesSite Not Available
Columbia Dermatology & Aesthetics
Columbia, South Carolina 29212
United StatesSite Not Available
Goodlettsville Dermatology Research
Goodlettsville, Tennessee 37072
United StatesSite Not Available
Advanced Research Experts
Nashville, Tennessee 37211
United StatesSite Not Available
Belle Meade Dermatology Research
Nashville, Tennessee 37205
United StatesActive - Recruiting
Goodlettsville Dermatology Research
Goodlettsville 4625282, Tennessee 4662168 37072
United StatesSite Not Available
Advanced Research Experts
Nashville 4644585, Tennessee 4662168 37211
United StatesSite Not Available
Arlington Research Center, inc.
Arlington, Texas 76011
United StatesSite Not Available
Center for Clinical Studies, LTD. LLP
Houston, Texas 77004
United StatesSite Not Available
Austin Institute for Clinical Research (AICR) - Pflugerville
Pflugerville, Texas 78660
United StatesSite Not Available
Progressive Clinical Research
San Antonio, Texas 78213
United StatesSite Not Available
Texas Dermatology and Laser Specialists
San Antonio, Texas 78218
United StatesActive - Recruiting
Center for Clinical Studies, LTD. LLP
Webster, Texas 77598
United StatesSite Not Available
Arlington Research Center, inc.
Arlington 4671240, Texas 4736286 76011
United StatesSite Not Available
Center for Clinical Studies, LTD. LLP
Houston 4699066, Texas 4736286 77004
United StatesSite Not Available
Progressive Clinical Research
San Antonio 4726206, Texas 4736286 78213
United StatesSite Not Available
Texas Dermatology and Laser Specialists
San Antonio 4726206, Texas 4736286 78218
United StatesSite Not Available
Center for Clinical Studies, LTD. LLP
Webster 4740423, Texas 4736286 77598
United StatesSite Not Available
James Song, MD (James Song)
Bellevue, Washington 98004
United StatesSite Not Available
James Song, MD (James Song)
Bellevue 5786882, Washington 5815135 98004
United StatesSite Not Available
Cheyenne Skin Clinic
Cheyenne, Wyoming 82009
United StatesSite Not Available

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