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Promising drug may ease painful genital psoriasis

NCT ID NCT06611163

Symptom relief Sponsor: Sun Pharmaceutical Industries Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study tests an injected drug called tildrakizumab for people with moderate to severe genital psoriasis. About 206 adults will receive either the drug or a placebo to see if it clears skin and reduces itching. The goal is to improve comfort and quality of life in this sensitive area.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

206 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Moderate to severe genital psoriasis

Contacts and locations

Locations

  • "Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o"

    Malbork, Warmian-Masurian Voivodeship, 82-200, Poland

  • Advanced Research Experts

    Nashville, Tennessee, 37211, United States

  • Allergo-Derm Bakos Kft

    Baross U 20., 5000, Hungary

  • Amicis Research Center

    Northridge, California, 91324, United States

  • Arlington Research Center, inc.

    Arlington, Texas, 76011, United States

  • Aversi Clinic

    Tbilisi, 160, Georgia

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024, United States

  • Care Access Holsamed Katowice

    Katowice, 40-600, Poland

  • Center for Clinical Studies, LTD. LLP

    Houston, Texas, 77004, United States

  • Center for Clinical Studies, LTD. LLP

    Webster, Texas, 77598, United States

  • Center for Dermatology Clinical Research, Inc

    Fremont, California, 94538, United States

  • Centrum Medyczne \All-Med\ spolka komandytowa

    Krakow, Malopolska, 30-033, Poland

  • Clinical Best Solution Sp. z o.o Sp. k. w Lublinie

    Lublin, 20-011, Poland

  • Clinical Best Solutions SP. Z.O.O. SP.K.

    Warsaw, 00-710, Poland

  • Coral Gables Dermatology & Aesthetics

    Coral Cables, Florida, 33134, United States

  • David Abuladze Clinic (DAC)

    Tbilisi, 179, Georgia

  • Dermatology Affiliates Research Institute, LLC

    Atlanta, Georgia, 30305, United States

  • Dermatology Institute and Skin Care Center, Inc. DBA Clinical Science Institute

    Santa Monica, California, 90404, United States

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Equity Medical

    New York, New York, 10023, United States

  • Florida Academic Centers Research and Education, LLC

    Coral Gables, Florida, 33134, United States

  • Forest Hills Dermatology

    Kew Gardens, New York, 11415, United States

  • Genomics Medical Research

    Miami, Florida, 33157, United States

  • Goodlettsville Dermatology Research

    Goodlettsville, Tennessee, 37072, United States

  • Hickory Dermatology Research Center, LLC

    Hickory, North Carolina, 28602, United States

  • Homestead Associates in Research Inc

    Homestead, Florida, 33033, United States

  • JSC Curatio

    Tbilisi, 144, Georgia

  • James Song, MD (James Song)

    Bellevue, Washington, 98004, United States

  • Javara Inc/ Tryon Medical Partners, PLLC

    Matthews, North Carolina, 28105, United States

  • Klinika Ambroziak

    Warszswa, 02-953, Poland

  • LA Universal Research Center Inc, Suite 1

    Los Angeles, California, 90057, United States

  • Lidia Rajzer-Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny

    Krakow, 30-438, Poland

  • Luxderm Specjalistyczny Gabinet Dermatologiczny

    Lublin, Lubslskie, 20-573, Poland

  • MC Medconsult-Lovech

    Lovech, 5500, Bulgaria

  • Mcintosh Clinic, PC

    Thomasville, Georgia, 31792, United States

  • Med-Care Research

    Miami, Florida, 33165, United States

  • Medconsult Pleven

    Pleven, 5800, Bulgaria

  • New Vision Univestiry Hospital

    Tbilisi, 159, Georgia

  • Niepubliczny Zakladu Opieki Zdrowotnej MultiMedica s.c.

    Wroclaw, Lower Silesian Voivodeship, 51-503, Poland

  • Oakland Hills Dermatology PC

    Auburn Hills, Michigan, 48326, United States

  • Oregon Medical Research Center

    Portland, Oregon, 97201, United States

  • Paradigm Clinical Research

    Wheat Ridge, Colorado, 80033, United States

  • Progressive Clinical Research

    San Antonio, Texas, 78213, United States

  • Raymann

    Tbilisi, 186, Georgia

  • Skin Specialists, PC

    Omaha, Nebraska, 68144, United States

  • Smary Cures Clinical Research

    Anaheim, California, 92806, United States

  • T. Joseph Raoof MD, Inc./Encino Research Center

    Encino, California, 91436, United States

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218, United States

  • The Derm Institute of West Michigan

    Caledonia, Michigan, 49316, United States

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168, United States

  • The Indiana Clinical Trials Center Optima Research Boardman

    Boardman, Ohio, 44512, United States

  • The Moses H. Cone Memorial Hospital Operating Corporation

    Greensboro, North Carolina, 27401, United States

  • Therapeutics Clinical Research

    San Diego, California, 92123, United States

  • University of Debrecen Dept of Dermatology

    Debrecen, Hajdú-Bihar, H-4032, Hungary

  • Uniwersytecki Szpital Kliniczny, Klinika Dermatologii

    Rzeszw, Podkarpackie Voivodeship, 35-055, Poland

  • Zdrowie Osteo-Medic s.c.

    Bialystok-Podlaskie, 15-351, Poland