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

Last updated: May 19, 2025
Sponsor: Sun Pharmaceutical Industries Limited
Overall Status: Active - Recruiting

Phase

3

Condition

Scalp Disorders

Warts

Rosacea

Treatment

Tildrakizumab 100 mg

Placebo

Clinical Study ID

NCT06611163
TILD-24-01
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ability to understand the purpose and risks of the trial, willingness and ability tocomply with the protocol, and provide written informed consent in accordance withinstitutional 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 andbaseline 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 withtopical therapy or the subject is intolerant to topical therapy

  6. Negative evaluation for TB within 4 weeks before initiating IMP, defined as anegative QuantiFERON test. Subjects with a positive QuantiFERON test or 2 successiveindeterminate

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 anyother pulmonary infectious diseases),

  • if prior latent TB infection, must have history of adequate prophylaxis (per localstandard of care),

  • if presence of latent TB is established, then treatment according to local countryguidelines must have been followed for 4 weeks, prior to dosing in the study atVisit 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

Exclusion Criteria:

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

  2. Planned surgical intervention between Baseline and the Week 16 evaluation for apre-treatment condition.

  3. Active infection or history of infections as follows:

  • any active infection (bacterial, fungal or viral) for which systemicanti-infectives were used within 28 days prior to first investigationalmedicinal product (IMP) dose, with the last dose having been received within 7days 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 dosehaving been received within 7 days of Screening,

  • recurrent or chronic infections, e.g., chronic pyelonephritis, chronicosteomyelitis, bronchiectasis, or other active infection that, in the opinionof the Investigator, might cause participation in this study to be detrimentalto the subject.

  1. Any concurrent medical condition or uncontrolled, clinically significant systemicdisease ( e.g., renal failure, heart failure, hypertension, liver disease, diabetes,or anemia) that, in the opinion of the Investigator, could jeopardize subject safetyor compliance with the protocol.

Study Design

Total Participants: 192
Treatment Group(s): 2
Primary Treatment: Tildrakizumab 100 mg
Phase: 3
Study Start date:
March 21, 2025
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • MC Medconsult-Lovech

    Lovech, 5500
    Bulgaria

    Site Not Available

  • Medconsult Pleven

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Diagnostic Consulatative Center

    Sofia, 1528
    Bulgaria

    Site Not Available

  • Medical Centre Regina Life Clinic

    Sofia, 1415
    Bulgaria

    Site Not Available

  • UMHAT Tsaritsa Yoanna-ISUL

    Sofia, 1527
    Bulgaria

    Site Not Available

  • Aversi Clinic

    Tbilisi, 160
    Georgia

    Site Not Available

  • David Abuladze Clinic (DAC)

    Tbilisi, 179
    Georgia

    Site Not Available

  • JSC Curatio

    Tbilisi, 144
    Georgia

    Site Not Available

  • New Vision Univestiry Hospital

    Tbilisi, 159
    Georgia

    Site Not Available

  • Raymann

    Tbilisi, 186
    Georgia

    Site Not Available

  • University of Debrecen Dept of Dermatology

    Debrecen, Hajdu-Bihar H-4032
    Hungary

    Site Not Available

  • Allergo-Derm Bakos Kft

    Baross U 20., 5000
    Hungary

    Site Not Available

  • Niepubliczny Zakladu Opieki Zdrowotnej MultiMedica s.c.

    Wroclaw, Dolnoslaskie 51-503
    Poland

    Site Not Available

  • Luxderm Specjalistyczny Gabinet Dermatologiczny

    Lublin, Lubslskie 20-573
    Poland

    Site Not Available

  • Centrum Medyczne \All-Med\ spolka komandytowa

    Krakow, Malopolska 30-033
    Poland

    Site Not Available

  • Miejski Szpital Zespolony

    Gdynia, Pomorskie 81-415
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny, Klinika Dermatologii

    Rzeszw, Subcarpathian Voivodeship 35-055
    Poland

    Site Not Available

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

    Malbork, Warminsko-Mazurskie 82-200
    Poland

    Site Not Available

  • Zdrowie Osteo-Medic s.c.

    Bialystok-Podlaskie, 15-351
    Poland

    Site Not Available

  • Care Access Gdansk

    Gdansk, 80-546
    Poland

    Site Not Available

  • Care Access Holsamed Katowice

    Katowice, 40-600
    Poland

    Site Not Available

  • Lidia Rajzer-Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny

    Krakow, 30-438
    Poland

    Site Not Available

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

    Lublin, 20-011
    Poland

    Site Not Available

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

    Warsaw, 00-710
    Poland

    Site Not Available

  • Klinika Ambroziak

    Warszswa, 02-953
    Poland

    Site Not Available

  • Medical Dermatology Specialists

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Smary Cures Clinical Research

    Anaheim, California 92806
    United States

    Site Not Available

  • California Dermatology & Clinical Research Institute

    Encinitas, California 92024
    United States

    Site Not Available

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

    Encino, California 91436
    United States

    Site Not Available

  • First OC Dermatology Research, Inc

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Center for Dermatology Clinical Research, Inc

    Fremont, California 94538
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • LA Universal Research Center Inc, Suite 1

    Los Angeles, California 90057
    United States

    Site Not Available

  • Amicis Research Center

    Northridge, California 91324
    United States

    Site Not Available

  • Therapeutics Clinical Research

    San Diego, California 92123
    United States

    Site Not Available

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

    Santa Monica, California 90404
    United States

    Site Not Available

  • Coral Gables Dermatology & Aesthetics

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Florida Academic Centers Research and Education, LLC

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Superior Associates in Research, LLC

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Homestead Associates in Research Inc

    Homestead, Florida 33033
    United States

    Site Not Available

  • Genomics Medical Research

    Miami, Florida 33157
    United States

    Site Not Available

  • Med-Care Research

    Miami, Florida 33165
    United States

    Site Not Available

  • Dermatology Affiliates Research Institute, LLC

    Atlanta, Georgia 30305
    United States

    Site Not Available

  • Javara Inc. / Privia Medical Group Georgia, LLC

    Fayetteville, Georgia 30214
    United States

    Site Not Available

  • Mcintosh Clinic, PC

    Thomasville, Georgia 31792
    United States

    Site Not Available

  • The Indiana Clinical Trials Center

    Plainfield, Indiana 46168
    United States

    Active - Recruiting

  • Oakland Hills Dermatology PC

    Auburn Hills, Michigan 48326
    United States

    Site Not Available

  • The Derm Institute of West Michigan

    Caledonia, Michigan 49316
    United States

    Site Not Available

  • Hamzavi Dermatology

    Fort Gratiot, Michigan 48059-3526
    United States

    Site Not Available

  • Central Missouri Dermatology Research, LLC

    Columbia Falls, Montana 65201
    United States

    Site Not Available

  • Skin Specialists, PC

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Forest Hills Dermatology

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Equity Medical

    New York, New York 10023
    United States

    Active - Recruiting

  • The Moses H. Cone Memorial Hospital Operating Corporation

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Hickory Dermatology Research Center, LLC

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • Javara Inc/ Tryon Medical Partners, PLLC

    Matthews, North Carolina 28105
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27104
    United States

    Site Not Available

  • Bexley Dermatology Research

    Bexley, Ohio 43209
    United States

    Site Not Available

  • The Indiana Clinical Trials Center Optima Research Boardman

    Boardman, Ohio 44512
    United States

    Active - Recruiting

  • Wright State Physicians

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97201
    United States

    Site Not Available

  • Columbia Dermatology & Aesthetics

    Columbia, South Carolina 29212
    United States

    Site Not Available

  • Goodlettsville Dermatology Research

    Goodlettsville, Tennessee 37072
    United States

    Site Not Available

  • Advanced Research Experts

    Nashville, Tennessee 37211
    United States

    Site Not Available

  • Belle Meade Dermatology Research

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Arlington Research Center, inc.

    Arlington, Texas 76011
    United States

    Site Not Available

  • Center for Clinical Studies, LTD. LLP

    Houston, Texas 77004
    United States

    Site Not Available

  • Austin Institute for Clinical Research (AICR) - Pflugerville

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Center for Clinical Studies, LTD. LLP

    Webster, Texas 77598
    United States

    Active - Recruiting

  • James Song, MD (James Song)

    Bellevue, Washington 98004
    United States

    Active - Recruiting

  • Cheyenne Skin Clinic

    Cheyenne, Wyoming 82009
    United States

    Site Not Available

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