A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis

Status: Recruiting
Location: See all (74) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Phase 3 study to evaluate the efficacy and safety of subcutaneous tildrakizumab in subjects with moderate to severe genital psoriasis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional 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 and baseline 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 with topical therapy or the subject is intolerant to topical therapy

⁃ Negative evaluation for TB within 4 weeks before initiating IMP, defined as a negative QuantiFERON test. Subjects with a positive QuantiFERON test or 2 successive indeterminate

‣ 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 any other pulmonary infectious diseases),

• if prior latent TB infection, must have history of adequate prophylaxis (per local standard of care),

• if presence of latent TB is established, then treatment according to local country guidelines must have been followed for 4 weeks, prior to dosing in the study at Visit 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

Locations
United States
Arizona
Medical Dermatology Specialists
NOT_YET_RECRUITING
Phoenix
California
Smary Cures Clinical Research
RECRUITING
Anaheim
California Dermatology & Clinical Research Institute
RECRUITING
Encinitas
T. Joseph Raoof MD, Inc./Encino Research Center
RECRUITING
Encino
First OC Dermatology Research, Inc
WITHDRAWN
Fountain Valley
Center for Dermatology Clinical Research, Inc
RECRUITING
Fremont
Dermatology Research Associates
RECRUITING
Los Angeles
LA Universal Research Center Inc, Suite 1
RECRUITING
Los Angeles
Amicis Research Center
RECRUITING
Northridge
Therapeutics Clinical Research
RECRUITING
San Diego
Dermatology Institute and Skin Care Center, Inc. DBA Clinical Science Institute
RECRUITING
Santa Monica
Colorado
Paradigm Clinical Research
RECRUITING
Wheat Ridge
Florida
Coral Gables Dermatology & Aesthetics
RECRUITING
Coral Gables
Florida Academic Centers Research and Education, LLC
NOT_YET_RECRUITING
Coral Gables
Superior Associates in Research, LLC
WITHDRAWN
Hialeah
Homestead Associates in Research Inc
RECRUITING
Homestead
Genomics Medical Research
RECRUITING
Miami
Med-Care Research
RECRUITING
Miami
Georgia
Dermatology Affiliates Research Institute, LLC
RECRUITING
Atlanta
Javara Inc. / Privia Medical Group Georgia, LLC
RECRUITING
Fayetteville
Mcintosh Clinic, PC
RECRUITING
Thomasville
Indiana
The Indiana Clinical Trials Center
RECRUITING
Plainfield
Michigan
Oakland Hills Dermatology PC
RECRUITING
Auburn Hills
The Derm Institute of West Michigan
RECRUITING
Caledonia
Hamzavi Dermatology
RECRUITING
Fort Gratiot
Montana
Central Missouri Dermatology Research, LLC
WITHDRAWN
Columbia Falls
North Carolina
The Moses H. Cone Memorial Hospital Operating Corporation
RECRUITING
Greensboro
Hickory Dermatology Research Center, LLC
RECRUITING
Hickory
Javara Inc/ Tryon Medical Partners, PLLC
RECRUITING
Matthews
Wake Forest University Health Sciences
NOT_YET_RECRUITING
Winston-salem
Nebraska
Skin Specialists, PC
RECRUITING
Omaha
New York
Forest Hills Dermatology
RECRUITING
Kew Gardens
Equity Medical
RECRUITING
New York
Ohio
Bexley Dermatology Research
WITHDRAWN
Bexley
The Indiana Clinical Trials Center Optima Research Boardman
RECRUITING
Boardman
Wright State Physicians
RECRUITING
Fairborn
Oregon
Oregon Medical Research Center
RECRUITING
Portland
South Carolina
Columbia Dermatology & Aesthetics
RECRUITING
Columbia
Tennessee
Goodlettsville Dermatology Research
RECRUITING
Goodlettsville
Advanced Research Experts
NOT_YET_RECRUITING
Nashville
Belle Meade Dermatology Research
RECRUITING
Nashville
Texas
Arlington Research Center, inc.
RECRUITING
Arlington
Center for Clinical Studies, LTD. LLP
RECRUITING
Houston
Austin Institute for Clinical Research (AICR) - Pflugerville
RECRUITING
Pflugerville
Progressive Clinical Research
RECRUITING
San Antonio
Texas Dermatology and Laser Specialists
RECRUITING
San Antonio
Center for Clinical Studies, LTD. LLP
RECRUITING
Webster
Washington
James Song, MD (James Song)
RECRUITING
Bellevue
Wyoming
Cheyenne Skin Clinic
RECRUITING
Cheyenne
Other Locations
Bulgaria
MC Medconsult-Lovech
RECRUITING
Lovech
Medconsult Pleven
RECRUITING
Pleven
Diagnostic Consulatative Center
NOT_YET_RECRUITING
Sofia
Medical Centre Regina Life Clinic
NOT_YET_RECRUITING
Sofia
UMHAT Tsaritsa Yoanna-ISUL
NOT_YET_RECRUITING
Sofia
Georgia
Aversi Clinic
RECRUITING
Tbilisi
David Abuladze Clinic (DAC)
RECRUITING
Tbilisi
JSC Curatio
RECRUITING
Tbilisi
New Vision Univestiry Hospital
RECRUITING
Tbilisi
Raymann
RECRUITING
Tbilisi
Hungary
Allergo-Derm Bakos Kft
RECRUITING
Baross U 20.
University of Debrecen Dept of Dermatology
NOT_YET_RECRUITING
Debrecen
Poland
Zdrowie Osteo-Medic s.c.
RECRUITING
Bialystok-podlaskie
Care Access Gdansk
NOT_YET_RECRUITING
Gdansk
Miejski Szpital Zespolony
WITHDRAWN
Gdynia
Care Access Holsamed Katowice
RECRUITING
Katowice
Centrum Medyczne \All-Med\ spolka komandytowa
RECRUITING
Krakow
Lidia Rajzer-Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny
RECRUITING
Krakow
Clinical Best Solution Sp. z o.o Sp. k. w Lublinie
RECRUITING
Lublin
Luxderm Specjalistyczny Gabinet Dermatologiczny
RECRUITING
Lublin
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o
RECRUITING
Malbork
Uniwersytecki Szpital Kliniczny, Klinika Dermatologii
RECRUITING
Rzeszw
Clinical Best Solutions SP. Z.O.O. SP.K.
RECRUITING
Warsaw
Klinika Ambroziak
RECRUITING
Warszswa
Niepubliczny Zakladu Opieki Zdrowotnej MultiMedica s.c.
RECRUITING
Wroclaw
Contact Information
Primary
Head, Clinical development
Clinical.Trial@sunpharma.com
9122 66455645
Time Frame
Start Date: 2025-03-21
Estimated Completion Date: 2028-01
Participants
Target number of participants: 192
Treatments
Experimental: Tildrakizumab 100 mg
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Sun Pharmaceutical Industries Limited

This content was sourced from clinicaltrials.gov