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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Moderate to Severe Genital Psoriasis

In brief

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

Key facts

Study ID

NCT06611163

Run by

Sun Pharmaceutical Industries Limited

People needed

206

Starts

2025-03-21

Expected to finish

2027-02-01

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
• Planned surgical intervention between Baseline and the Week 16 evaluation for a pre-treatment condition.
• 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.
• 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.

Where it is running

• 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
• Smary Cures Clinical Research — Anaheim, California, United States

Full record on ClinicalTrials.gov

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