A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With 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 study to evaluate the efficacy and safety of subcutaneous Tildrakizumab in subjects with moderate to severe genital psoriasis.

Study Overview

• Status: Active, not recruiting
• Conditions: Moderate to Severe Genital Psoriasis
• Intervention / Treatment: Drug: Tildrakizumab 100 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Lovech, Bulgaria, 5500
    • MC Medconsult-Lovech
  • Pleven, Bulgaria, 5800
    • Medconsult Pleven
• Georgia
  • Tbilisi, Georgia, 144
    • JSC Curatio
  • Tbilisi, Georgia, 159
    • New Vision Univestiry Hospital
  • Tbilisi, Georgia, 160
    • Aversi Clinic
  • Tbilisi, Georgia, 179
    • David Abuladze Clinic (DAC)
  • Tbilisi, Georgia, 186
    • Raymann
• Hungary
  • Baross U 20., Hungary, 5000
    • Allergo-Derm Bakos Kft
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, H-4032
      • University of Debrecen Dept of Dermatology
• Poland
  • Bialystok-Podlaskie, Poland, 15-351
    • Zdrowie Osteo-Medic s.c.
  • Katowice, Poland, 40-600
    • Care Access Holsamed Katowice
  • Krakow, Poland, 30-438
    • Lidia Rajzer-Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny
  • Lublin, Poland, 20-011
    • Clinical Best Solution Sp. z o.o Sp. k. w Lublinie
  • Warsaw, Poland, 00-710
    • Clinical Best Solutions SP. Z.O.O. SP.K.
  • Warszswa, Poland, 02-953
    • Klinika Ambroziak
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 51-503
      • Niepubliczny Zakladu Opieki Zdrowotnej MultiMedica s.c.
  • Lubslskie
    • Lublin, Lubslskie, Poland, 20-573
      • Luxderm Specjalistyczny Gabinet Dermatologiczny
  • Malopolska
    • Krakow, Malopolska, Poland, 30-033
      • Centrum Medyczne \All-Med\ spolka komandytowa
  • Podkarpackie Voivodeship
    • Rzeszw, Podkarpackie Voivodeship, Poland, 35-055
      • Uniwersytecki Szpital Kliniczny, Klinika Dermatologii
  • Warmian-Masurian Voivodeship
    • Malbork, Warmian-Masurian Voivodeship, Poland, 82-200
      • "Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o"
• United States
  • California
    • Anaheim, California, United States, 92806
      • Smary Cures Clinical Research
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Encino, California, United States, 91436
      • T. Joseph Raoof MD, Inc./Encino Research Center
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research, Inc
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Los Angeles, California, United States, 90057
      • LA Universal Research Center Inc, Suite 1
    • Northridge, California, United States, 91324
      • Amicis Research Center
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • Santa Monica, California, United States, 90404
      • Dermatology Institute and Skin Care Center, Inc. DBA Clinical Science Institute
  • Colorado
    • Wheat Ridge, Colorado, United States, 80033
      • Paradigm Clinical Research
  • Florida
    • Coral Cables, Florida, United States, 33134
      • Coral Gables Dermatology & Aesthetics
    • Coral Gables, Florida, United States, 33134
      • Florida Academic Centers Research and Education, LLC
    • Homestead, Florida, United States, 33033
      • Homestead Associates In Research Inc
    • Miami, Florida, United States, 33165
      • Med-Care Research
    • Miami, Florida, United States, 33157
      • Genomics Medical Research
  • Georgia
    • Atlanta, Georgia, United States, 30305
      • Dermatology Affiliates Research Institute, LLC
    • Thomasville, Georgia, United States, 31792
      • Mcintosh Clinic, PC
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Oakland Hills Dermatology PC
    • Caledonia, Michigan, United States, 49316
      • The Derm Institute of West Michigan
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • New York
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology
    • New York, New York, United States, 10023
      • Equity Medical
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • The Moses H. Cone Memorial Hospital Operating Corporation
    • Hickory, North Carolina, United States, 28602
      • Hickory Dermatology Research Center, LLC
    • Matthews, North Carolina, United States, 28105
      • Javara Inc/ Tryon Medical Partners, PLLC
  • Ohio
    • Boardman, Ohio, United States, 44512
      • The Indiana Clinical Trials Center Optima Research Boardman
  • Oregon
    • Portland, Oregon, United States, 97201
      • Oregon Medical Research Center
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Goodlettsville Dermatology Research
    • Nashville, Tennessee, United States, 37211
      • Advanced Research Experts
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, inc.
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, LTD. LLP
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies, LTD. LLP
  • Washington
    • Bellevue, Washington, United States, 98004
      • James Song, MD (James Song)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tildrakizumab 100 mg; Participants will receive Tildrakizumab 100 milligrams (mg) subcutaneous (SC) injection on Day 1, Week 4 and every 12 weeks thereafter until the end of treatment.	Drug: Tildrakizumab 100 mg; Tildrakizumab 100 mg SC injection on Day 1, Week 4 and every 12 weeks thereafter
Placebo Comparator: Placebo; Participants will receive placebo SC injection at Day 1 and Week 4. Participants initially randomized to placebo will be switched to receive Tildrakizumab 100 mg at Week 16, week 20 and every 12 weeks thereafter until the end of treatment.	Drug: Placebo; Placebo SC injection at Day 1 and Week 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with a modified sPGA-G score of clear (0) or minimal (1) with at-least a 2- point reduction from baseline	The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4) and incorporates an assessment of the severity of the three primary signs of the disease: erythema, elevation, and scaling. Higher scores indicate greater disease severity.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in the affected Body Surface Area (BSA)	The BSA will be measured using the palm method where the palm of the subject's hand (including the palmar aspect of the fingers) represents 1 % of the BSA. The affected areas are then calculated by their size compared to the subject's palm.	Week 16
Change from baseline in genital psoriasis symptoms scale [GPSS] total score and individual items scores	The GPSS contains eight items regarding genital psoriasis symptoms. The items separately address itch, pain, discomfort, stinging, burning, redness, scaling, and cracking on an 11-point scale where 0 represents ''no symptom'' and 10 represents ''worst symptom imaginable". Each of the eight items are scored separately; in addition, a total score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms) is reported.	Week 16
Proportion of subjects with psoriasis area and severity index [PASI] 75 response	The PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).	Week 16
Proportion of subjects with PASI 90 response	The PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).	Week 16
Proportion of subjects, with a baseline score of ≥ 4, who achieve at-least 4-point improvement in weekly average genital psoriasis itch numerical rating scale [GPI-NRS] within the GPSS for subjects	The GPI-NRS is a self-reported measure where participants will assess their psoriasis symptoms in the genital area and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch.	Week 16
Proportion of subjects with PASI 100 response, in subjects with BSA <10%	The PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).	Week 16

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries Limited

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2025
• Primary Completion (Actual): January 21, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; tildrakizumab
• Other Study ID Numbers: TILD-24-01; 2024-515672-12 (Other Identifier: EU CTR Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No