ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-03-21

Study Completion:2027-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06611163

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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.	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.

Inclusion Criteria

Exclusion 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
* 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.

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.

Contacts and Locations

Study Locations (Sites)

Medical Dermatology Specialists

Phoenix, Arizona, 85006

United States

Smary Cures Clinical Research

Anaheim, California, 92806

United States

California Dermatology & Clinical Research Institute

Encinitas, California, 92024

United States

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

Encino, California, 91436

United States

Center for Dermatology Clinical Research, Inc

Fremont, California, 94538

United States

Dermatology Research Associates

Los Angeles, California, 90045

United States

LA Universal Research Center Inc, Suite 1

Los Angeles, California, 90057

United States

Amicis Research Center

Northridge, California, 91324

United States

Therapeutics Clinical Research

San Diego, California, 92123

United States

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

Santa Monica, California, 90404

United States

Paradigm Clinical Research

Wheat Ridge, Colorado, 80033

United States

Coral Gables Dermatology & Aesthetics

Coral Gables, Florida, 33134

United States

Florida Academic Centers Research and Education, LLC

Coral Gables, Florida, 33134

United States

Homestead Associates in Research Inc

Homestead, Florida, 33033

United States

Genomics Medical Research

Miami, Florida, 33157

United States

Med-Care Research

Miami, Florida, 33165

United States

Dermatology Affiliates Research Institute, LLC

Atlanta, Georgia, 30305

United States

Mcintosh Clinic, PC

Thomasville, Georgia, 31792

United States

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168

United States

Oakland Hills Dermatology PC

Auburn Hills, Michigan, 48326

United States

The Derm Institute of West Michigan

Caledonia, Michigan, 49316

United States

Skin Specialists, PC

Omaha, Nebraska, 68144

United States

Forest Hills Dermatology

Kew Gardens, New York, 11415

United States

Equity Medical

New York, New York, 10023

United States

The Moses H. Cone Memorial Hospital Operating Corporation

Greensboro, North Carolina, 27401

United States

Hickory Dermatology Research Center, LLC

Hickory, North Carolina, 28602

United States

Javara Inc/ Tryon Medical Partners, PLLC

Matthews, North Carolina, 28105

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27104

United States

The Indiana Clinical Trials Center Optima Research Boardman

Boardman, Ohio, 44512

United States

Oregon Medical Research Center

Portland, Oregon, 97201

United States

Goodlettsville Dermatology Research

Goodlettsville, Tennessee, 37072

United States

Advanced Research Experts

Nashville, Tennessee, 37211

United States

Arlington Research Center, inc.

Arlington, Texas, 76011

United States

Center for Clinical Studies, LTD. LLP

Houston, Texas, 77004

United States

Progressive Clinical Research

San Antonio, Texas, 78213

United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218

United States

Center for Clinical Studies, LTD. LLP

Webster, Texas, 77598

United States

James Song, MD (James Song)

Bellevue, Washington, 98004

United States

Collaborators and Investigators

Sponsor: Sun Pharmaceutical Industries Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-21

Study Completion Date2027-02

Study Record Updates

Study Start Date2025-03-21

Study Completion Date2027-02

Terms related to this study

Additional Relevant MeSH Terms

Moderate to Severe Genital Psoriasis