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Clinical Trials in the USA / NCT06611163
Active, not recruiting Phase 3

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

NCT06611163 · tracked via the Priya Life Science USA tracker
Sponsor
Sun Pharmaceutical Industries Limited
Phase
Phase 3
Started
2025-03-21
Last updated
2026-09-01

Condition(s) studied

Moderate to Severe Genital Psoriasis

Investigational drug(s) / intervention(s)

Tildrakizumab 100 mgPlacebo

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
Smary Cures Clinical Research Anaheim California
California Dermatology & Clinical Research Institute Encinitas California
T. Joseph Raoof MD, Inc./Encino Research Center Encino California
Center for Dermatology Clinical Research, Inc Fremont California
Dermatology Research Associates Los Angeles California
LA Universal Research Center Inc, Suite 1 Los Angeles California
Amicis Research Center Northridge California
Therapeutics Clinical Research San Diego California
Dermatology Institute and Skin Care Center, Inc. DBA Clinical Science Institute Santa Monica California
Paradigm Clinical Research Wheat Ridge Colorado
Coral Gables Dermatology & Aesthetics Coral Cables Florida
Florida Academic Centers Research and Education, LLC Coral Gables Florida
Homestead Associates in Research Inc Homestead Florida
Genomics Medical Research Miami Florida
Med-Care Research Miami Florida
Dermatology Affiliates Research Institute, LLC Atlanta Georgia
Mcintosh Clinic, PC Thomasville Georgia
The Indiana Clinical Trials Center Plainfield Indiana
Oakland Hills Dermatology PC Auburn Hills Michigan
The Derm Institute of West Michigan Caledonia Michigan
Skin Specialists, PC Omaha Nebraska
Forest Hills Dermatology Kew Gardens New York
Equity Medical New York New York
The Moses H. Cone Memorial Hospital Operating Corporation Greensboro North Carolina
Hickory Dermatology Research Center, LLC Hickory North Carolina
Javara Inc/ Tryon Medical Partners, PLLC Matthews North Carolina
The Indiana Clinical Trials Center Optima Research Boardman Boardman Ohio
Oregon Medical Research Center Portland Oregon
Goodlettsville Dermatology Research Goodlettsville Tennessee
Advanced Research Experts Nashville Tennessee
Arlington Research Center, inc. Arlington Texas
Center for Clinical Studies, LTD. LLP Houston Texas
Progressive Clinical Research San Antonio Texas
Texas Dermatology and Laser Specialists San Antonio Texas
Center for Clinical Studies, LTD. LLP Webster Texas
James Song, MD (James Song) Bellevue Washington
MC Medconsult-Lovech Lovech Bulgaria
Medconsult Pleven Pleven Bulgaria
JSC Curatio Tbilisi Georgia
New Vision Univestiry Hospital Tbilisi Georgia

+ 16 more sites — see the full list on the official registry below.

More Sun Pharmaceutical Industries Limited trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06611163 on ClinicalTrials.gov ↗ ← All trials in the USA