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Evaluating Tildrakizumab for Moderate to Severe Genital Psoriasis

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

Phase 3 Interventional Sun Pharmaceutical Industries Limited · NCT06611163

This study is testing if a new injection can help adults with moderate to severe genital psoriasis feel better when other treatments haven't worked.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment192 (estimated)
Ages18 Years and up
SexAll
SponsorSun Pharmaceutical Industries Limited Industry-sponsored
Drugs / interventionstildrakizumab
Locations73 sites (Phoenix, Arizona and 72 other locations)
Trial IDNCT06611163 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial aims to assess the efficacy and safety of subcutaneous tildrakizumab in patients suffering from moderate to severe genital psoriasis. Participants will receive either the active treatment or a placebo to determine the drug's effectiveness in managing their condition. The study will include adults aged 18 and older who have not responded adequately to topical therapies. The primary focus is on improving the symptoms and quality of life for those affected by this specific type of psoriasis.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with moderate to severe genital psoriasis that is inadequately controlled by topical treatments.

Not a fit: Patients with mild genital psoriasis or those who have not tried topical therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of moderate to severe genital psoriasis for patients who have not found relief with existing therapies.

How similar studies have performed: Other studies evaluating similar biologic treatments for psoriasis have shown promising results, indicating a potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Phoenix, Arizona and 72 other locations

+23 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Moderate to Severe Genital Psoriasis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.