A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis.
- Conditions
- Moderate to Severe Genital Psoriasis
- Interventions
- Drug: Placebo
- Registration Number
- NCT06611163
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Phase 3 study to evaluate the efficacy and safety of subcutaneous tildrakizumab in subjects with moderate to severe genital psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 192
- 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
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Predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
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Planned surgical intervention between Baseline and the Week 16 evaluation for a pre-treatment condition.
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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.
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tildrakizumab 100 mg Tildrakizumab 100 mg - Placebo Tildrakizumab 100 mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Proportion of subjects with modified sPGA-G score of clear (0) or almost clear (1) with at-least a 2-point reduction from baseline Week 16 sPGA-G scale is a 6-point numerical scale that ranges from 0 (clear) to 5 (very severe)
- Secondary Outcome Measures
Name Time Method 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 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.
Mean change from baseline in the affected Body Surface Area (BSA) Week 16 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.
Change from baseline in genital psoriasis symptoms scale [GPSS] total score and individual items scores Week 16 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.Proportion of subjects with psoriasis area and severity index [PASI] 75 response Week 16 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).
Proportion of subjects with PASI 90 response Week 16 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).
Proportion of subjects with PASI 100 response, in subjects with BSA <10% Week 16 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).
Trial Locations
- Locations (72)
Medical Dermatology Specialists
🇺🇸Phoenix, Arizona, United States
Smary Cures Clinical Research
🇺🇸Anaheim, California, United States
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
T. Joseph Raoof MD, Inc./Encino Research Center
🇺🇸Encino, California, United States
First OC Dermatology Research, Inc
🇺🇸Fountain Valley, California, United States
Center for Dermatology Clinical Research, Inc
🇺🇸Fremont, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
LA Universal Research Center Inc, Suite 1
🇺🇸Los Angeles, California, United States
Amicis Research Center
🇺🇸Northridge, California, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
Dermatology Institute and Skin Care Center, Inc. DBA Clinical Science Institute
🇺🇸Santa Monica, California, United States
Coral Gables Dermatology & Aesthetics
🇺🇸Coral Gables, Florida, United States
Central Missouri Dermatology Research, LLC
🇺🇸Columbia Falls, Montana, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States
Forest Hills Dermatology
🇺🇸Kew Gardens, New York, United States
Equity Medical
🇺🇸New York, New York, United States
The Moses H. Cone Memorial Hospital Operating Corporation
🇺🇸Greensboro, North Carolina, United States
Hickory Dermatology Research Center, LLC
🇺🇸Hickory, North Carolina, United States
Javara Inc/ Tryon Medical Partners, PLLC
🇺🇸Matthews, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Bexley Dermatology Research
🇺🇸Bexley, Ohio, United States
The Indiana Clinical Trials Center Optima Research Boardman
🇺🇸Boardman, Ohio, United States
Superior Associates in Research, LLC
🇺🇸Hialeah, Florida, United States
Florida Academic Centers Research and Education, LLC
🇺🇸Coral Gables, Florida, United States
Homestead Associates in Research Inc
🇺🇸Homestead, Florida, United States
Genomics Medical Research
🇺🇸Miami, Florida, United States
Med-Care Research
🇺🇸Miami, Florida, United States
Dermatology Affiliates Research Institute, LLC
🇺🇸Atlanta, Georgia, United States
Javara Inc. / Privia Medical Group Georgia, LLC
🇺🇸Fayetteville, Georgia, United States
Mcintosh Clinic, PC
🇺🇸Thomasville, Georgia, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Oakland Hills Dermatology PC
🇺🇸Auburn Hills, Michigan, United States
The Derm Institute of West Michigan
🇺🇸Caledonia, Michigan, United States
Hamzavi Dermatology
🇺🇸Fort Gratiot, Michigan, United States
Wright State Physicians
🇺🇸Fairborn, Ohio, United States
Oregon Medical Research Center
🇺🇸Portland, Oregon, United States
Columbia Dermatology & Aesthetics
🇺🇸Columbia, South Carolina, United States
Goodlettsville Dermatology Research
🇺🇸Goodlettsville, Tennessee, United States
Belle Meade Dermatology Research
🇺🇸Nashville, Tennessee, United States
Advanced Research Experts
🇺🇸Nashville, Tennessee, United States
Arlington Research Center, inc.
🇺🇸Arlington, Texas, United States
Center for Clinical Studies, LTD. LLP
🇺🇸Webster, Texas, United States
Austin Institute for Clinical Research (AICR) - Pflugerville
🇺🇸Pflugerville, Texas, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
James Song, MD (James Song)
🇺🇸Bellevue, Washington, United States
Cheyenne Skin Clinic
🇺🇸Cheyenne, Wyoming, United States
MC Medconsult-Lovech
🇧🇬Lovech, Bulgaria
Medconsult Pleven
🇧🇬Pleven, Bulgaria
Medical Centre Regina Life Clinic
🇧🇬Sofia, Bulgaria
UMHAT Tsaritsa Yoanna-ISUL
🇧🇬Sofia, Bulgaria
Diagnostic Consulatative Center
🇧🇬Sofia, Bulgaria
JSC Curatio
🇬🇪Tbilisi, Georgia
New Vision Univestiry Hospital
🇬🇪Tbilisi, Georgia
Aversi Clinic
🇬🇪Tbilisi, Georgia
David Abuladze Clinic (DAC)
🇬🇪Tbilisi, Georgia
Raymann
🇬🇪Tbilisi, Georgia
University of Debrecen Dept of Dermatology
🇭🇺Debrecen, Hajdu-Bihar, Hungary
Allergo-Derm Bakos Kft
🇭🇺Baross U 20., Hungary
Niepubliczny Zakladu Opieki Zdrowotnej MultiMedica s.c.
🇵🇱Wroclaw, Dolnoslaskie, Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny
🇵🇱Lublin, Lubslskie, Poland
Centrum Medyczne \All-Med\ spolka komandytowa
🇵🇱Krakow, Malopolska, Poland
Miejski Szpital Zespolony
🇵🇱Gdynia, Pomorskie, Poland
Uniwersytecki Szpital Kliniczny, Klinika Dermatologii
🇵🇱Rzeszw, Subcarpathian Voivodeship, Poland
"Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o"
🇵🇱Malbork, Warminsko-Mazurskie, Poland
Zdrowie Osteo-Medic s.c.
🇵🇱Bialystok-Podlaskie, Poland
Care Access Gdansk
🇵🇱Gdansk, Poland
Care Access Holsamed Katowice
🇵🇱Katowice, Poland
Lidia Rajzer-Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny
🇵🇱Krakow, Poland
Clinical Best Solution Sp. z o.o Sp. k. w Lublinie
🇵🇱Lublin, Poland
Clinical Best Solutions SP. Z.O.O. SP.K.
🇵🇱Warsaw, Poland
Klinika Ambroziak
🇵🇱Warszswa, Poland