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

NCT06611163 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: TILD-24-01
• Study Type: interventional
• Target: 206
• Locations: 5 countries
• Sites: 56

Brief Summary

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

Conditions

Moderate to Severe Genital Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with a modified sPGA-G score of clear (0) or minimal (1) with at-least a 2- point reduction from baseline

  sPGA-G scale is a 6-point numerical scale that ranges from 0 (clear) to 5 (very severe)

  Week 16

Secondary Outcomes (6)

• 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

  Week 16

• Mean change from baseline in the affected Body Surface Area (BSA)

  Week 16

• Change from baseline in genital psoriasis symptoms scale [GPSS] total score and individual items scores

  Week 16

• Proportion of subjects with psoriasis area and severity index [PASI] 75 response

  Week 16

• Proportion of subjects with PASI 90 response

  Week 16

Study Arms (2)

Tildrakizumab 100 mg

EXPERIMENTAL

Drug: Tildrakizumab 100 mg

Placebo

PLACEBO COMPARATOR

Drug: Tildrakizumab 100 mg; Drug: Placebo

Interventions

Placebo DRUG

Placebo SC injection at Day 1 and Week 4

Placebo

Tildrakizumab 100 mg DRUG

Tildrakizumab 100 mg SC injection on Day 1, Week 4 and every 12 weeks thereafter

Placebo; Tildrakizumab 100 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (56)

Smary Cures Clinical Research

Anaheim, California, 92806, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

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

Encino, California, 91436, United States

Location

Center for Dermatology Clinical Research, Inc

Fremont, California, 94538, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

LA Universal Research Center Inc, Suite 1

Los Angeles, California, 90057, United States

Location

Amicis Research Center

Northridge, California, 91324, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

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

Santa Monica, California, 90404, United States

Location

Paradigm Clinical Research

Wheat Ridge, Colorado, 80033, United States

Location

Coral Gables Dermatology & Aesthetics

Coral Gables, Florida, 33134, United States

Location

Florida Academic Centers Research and Education, LLC

Coral Gables, Florida, 33134, United States

Location

Homestead Associates in Research Inc

Homestead, Florida, 33033, United States

Location

Genomics Medical Research

Miami, Florida, 33157, United States

Location

Med-Care Research

Miami, Florida, 33165, United States

Location

Dermatology Affiliates Research Institute, LLC

Atlanta, Georgia, 30305, United States

Location

Mcintosh Clinic, PC

Thomasville, Georgia, 31792, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Oakland Hills Dermatology PC

Auburn Hills, Michigan, 48326, United States

Location

The Derm Institute of West Michigan

Caledonia, Michigan, 49316, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Forest Hills Dermatology

Kew Gardens, New York, 11415, United States

Location

Equity Medical

New York, New York, 10023, United States

Location

The Moses H. Cone Memorial Hospital Operating Corporation

Greensboro, North Carolina, 27401, United States

Location

Hickory Dermatology Research Center, LLC

Hickory, North Carolina, 28602, United States

Location

Javara Inc/ Tryon Medical Partners, PLLC

Matthews, North Carolina, 28105, United States

Location

The Indiana Clinical Trials Center Optima Research Boardman

Boardman, Ohio, 44512, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97201, United States

Location

Goodlettsville Dermatology Research

Goodlettsville, Tennessee, 37072, United States

Location

Advanced Research Experts

Nashville, Tennessee, 37211, United States

Location

Arlington Research Center, inc.

Arlington, Texas, 76011, United States

Location

Center for Clinical Studies, LTD. LLP

Houston, Texas, 77004, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Center for Clinical Studies, LTD. LLP

Webster, Texas, 77598, United States

Location

James Song, MD (James Song)

Bellevue, Washington, 98004, United States

Location

MC Medconsult-Lovech

Lovech, 5500, Bulgaria

Location

Medconsult Pleven

Pleven, 5800, Bulgaria

Location

JSC Curatio

Tbilisi, 144, Georgia

Location

New Vision Univestiry Hospital

Tbilisi, 159, Georgia

Location

Aversi Clinic

Tbilisi, 160, Georgia

Location

David Abuladze Clinic (DAC)

Tbilisi, 179, Georgia

Location

Raymann

Tbilisi, 186, Georgia

Location

University of Debrecen Dept of Dermatology

Debrecen, Hajdú-Bihar, H-4032, Hungary

Location

Allergo-Derm Bakos Kft

Baross U 20., 5000, Hungary

Location

Niepubliczny Zakladu Opieki Zdrowotnej MultiMedica s.c.

Wroclaw, Lower Silesian Voivodeship, 51-503, Poland

Location

Luxderm Specjalistyczny Gabinet Dermatologiczny

Lublin, Lubslskie, 20-573, Poland

Location

Centrum Medyczne \All-Med\ spolka komandytowa

Krakow, Malopolska, 30-033, Poland

Location

Uniwersytecki Szpital Kliniczny, Klinika Dermatologii

Rzeszw, Podkarpackie Voivodeship, 35-055, Poland

Location

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

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

Location

Zdrowie Osteo-Medic s.c.

Bialystok-Podlaskie, 15-351, Poland

Location

Care Access Holsamed Katowice

Katowice, 40-600, Poland

Location

Lidia Rajzer-Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny

Krakow, 30-438, Poland

Location

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

Lublin, 20-011, Poland

Location

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

Warsaw, 00-710, Poland

Location

Klinika Ambroziak

Warszswa, 02-953, Poland

Location

MeSH Terms

Interventions

tildrakizumab

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 24, 2024
• Study Start: March 21, 2025
• Primary Completion: January 21, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

BU (2); HU (2); PL (11); GE (5); US (36)