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ACTIVE NOT RECRUITING

NCT06611163

PHASE3

A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis.

Sponsor: Sun Pharmaceutical Industries Limited

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

206

Start Date

2025-03-21

Completion Date

2027-02

Last Updated

2026-03-25

Healthy Volunteers

Conditions

Moderate to Severe Genital Psoriasis

Interventions

DRUG

Tildrakizumab 100 mg

Tildrakizumab 100 mg SC injection on Day 1, Week 4 and every 12 weeks thereafter

DRUG

Placebo

Placebo SC injection at Day 1 and Week 4

Inclusion Criteria: 1. 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 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: 1. Predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis. 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.

Locations (56)

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

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

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 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

Clinical Research Directory

A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis.

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (56)