A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis.
NCT ID: NCT06611163
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
206 participants
INTERVENTIONAL
2025-03-21
2027-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011)
NCT01729754
A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010)
NCT01722331
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis
NCT02718898
Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasis
NCT03897088
A Study to Determine the Optimal Dose of Tildrakizumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495) (MK-3222-003)
NCT01225731
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tildrakizumab 100 mg
Tildrakizumab 100 mg
Tildrakizumab 100 mg SC injection on Day 1, Week 4 and every 12 weeks thereafter
Placebo
Tildrakizumab 100 mg
Tildrakizumab 100 mg SC injection on Day 1, Week 4 and every 12 weeks thereafter
Placebo
Placebo SC injection at Day 1 and Week 4
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tildrakizumab 100 mg
Tildrakizumab 100 mg SC injection on Day 1, Week 4 and every 12 weeks thereafter
Placebo
Placebo SC injection at Day 1 and Week 4
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age ≥ 18 years of age at the time of signing consent
3. Diagnosis of moderate to severe psoriasis of the genital area at Screening and baseline defined as modified sPGA-G score of ≥3.
4. Presence of non-genital plaque psoriasis (BSA ≥1%) at both Screening and Baseline.
5. Presence of psoriasis of the genital area that is inadequately controlled with topical therapy or the subject is intolerant to topical therapy
6. 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
Exclusion Criteria
2. Planned surgical intervention between Baseline and the Week 16 evaluation for a pre-treatment condition.
3. Active infection or history of infections as follows:
* any active infection (bacterial, fungal or viral) for which systemic anti-infectives were used within 28 days prior to first investigational medicinal product (IMP) dose, with the last dose having been received within 7 days 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 dose having been received within 7 days of Screening,
* recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause participation in this study to be detrimental to the subject.
4. Any concurrent medical condition or uncontrolled, clinically significant systemic disease ( e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could jeopardize subject safety or compliance with the protocol.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Dermatology Specialists
Phoenix, Arizona, United States
Smary Cures Clinical Research
Anaheim, California, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
T. Joseph Raoof MD, Inc./Encino Research Center
Encino, California, United States
Center for Dermatology Clinical Research, Inc
Fremont, California, United States
Dermatology Research Associates
Los Angeles, California, United States
LA Universal Research Center Inc, Suite 1
Los Angeles, California, United States
Amicis Research Center
Northridge, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Dermatology Institute and Skin Care Center, Inc. DBA Clinical Science Institute
Santa Monica, California, United States
Paradigm Clinical Research
Wheat Ridge, Colorado, United States
Coral Gables Dermatology & Aesthetics
Coral Gables, Florida, United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, United States
Homestead Associates in Research Inc
Homestead, Florida, United States
Genomics Medical Research
Miami, Florida, United States
Med-Care Research
Miami, Florida, United States
Dermatology Affiliates Research Institute, LLC
Atlanta, Georgia, United States
Mcintosh Clinic, PC
Thomasville, Georgia, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Oakland Hills Dermatology PC
Auburn Hills, Michigan, United States
The Derm Institute of West Michigan
Caledonia, Michigan, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Forest Hills Dermatology
Kew Gardens, New York, United States
Equity Medical
New York, New York, United States
The Moses H. Cone Memorial Hospital Operating Corporation
Greensboro, North Carolina, United States
Hickory Dermatology Research Center, LLC
Hickory, North Carolina, United States
Javara Inc/ Tryon Medical Partners, PLLC
Matthews, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
The Indiana Clinical Trials Center Optima Research Boardman
Boardman, Ohio, United States
Oregon Medical Research Center
Portland, Oregon, United States
Goodlettsville Dermatology Research
Goodlettsville, Tennessee, United States
Advanced Research Experts
Nashville, Tennessee, United States
Arlington Research Center, inc.
Arlington, Texas, United States
Center for Clinical Studies, LTD. LLP
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Center for Clinical Studies, LTD. LLP
Webster, Texas, United States
James Song, MD (James Song)
Bellevue, Washington, United States
MC Medconsult-Lovech
Lovech, , Bulgaria
Medconsult Pleven
Pleven, , Bulgaria
Medical Centre Regina Life Clinic
Sofia, , Bulgaria
UMHAT Tsaritsa Yoanna-ISUL
Sofia, , Bulgaria
Diagnostic Consulatative Center
Sofia, , Bulgaria
JSC Curatio
Tbilisi, , Georgia
New Vision Univestiry Hospital
Tbilisi, , Georgia
Aversi Clinic
Tbilisi, , Georgia
David Abuladze Clinic (DAC)
Tbilisi, , Georgia
Raymann
Tbilisi, , Georgia
University of Debrecen Dept of Dermatology
Debrecen, Hajdú-Bihar, Hungary
Allergo-Derm Bakos Kft
Baross U 20., , Hungary
Niepubliczny Zakladu Opieki Zdrowotnej MultiMedica s.c.
Wroclaw, Lower Silesian Voivodeship, Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny
Lublin, Lubslskie, Poland
Centrum Medyczne \All-Med\ spolka komandytowa
Krakow, Malopolska, Poland
Uniwersytecki Szpital Kliniczny, Klinika Dermatologii
Rzeszw, Podkarpackie Voivodeship, Poland
"Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o"
Malbork, Warmian-Masurian Voivodeship, Poland
Zdrowie Osteo-Medic s.c.
Bialystok-Podlaskie, , Poland
Care Access Gdansk
Gdansk, , Poland
Care Access Holsamed Katowice
Katowice, , Poland
Lidia Rajzer-Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny
Krakow, , Poland
Clinical Best Solution Sp. z o.o Sp. k. w Lublinie
Lublin, , Poland
Clinical Best Solutions SP. Z.O.O. SP.K.
Warsaw, , Poland
Klinika Ambroziak
Warszswa, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TILD-24-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.