Clinical trial NCT06611163: A 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Moderate to Severe Genital Psoriasis
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2024-09-24
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects with modified sPGA-G score of clear (0) or almost clear (1) with at-least a 2-point reduction from baseline
timeFrame: Week 16
Secondary outcomes:
measure: 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
timeFrame: Week 16
measure: Mean change from baseline in the affected Body Surface Area (BSA)
timeFrame: Week 16
measure: Change from baseline in genital psoriasis symptoms scale [GPSS] total score and individual items scores
timeFrame: Week 16
measure: Proportion of subjects with psoriasis area and severity index [PASI] 75 response
timeFrame: Week 16
measure: Proportion of subjects with PASI 90 response
timeFrame: Week 16
measure: Proportion of subjects with PASI 100 response, in subjects with BSA <10%
timeFrame: Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Anaheim
country: United States
facility: Smary Cures Clinical Research
state: California
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Encino
country: United States
facility: T. Joseph Raoof MD, Inc./Encino Research Center
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology Research, Inc
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Los Angeles
country: United States
facility: LA Universal Research Center Inc, Suite 1
state: California
city: Northridge
country: United States
facility: Amicis Research Center
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Santa Monica
country: United States
facility: Dermatology Institute and Skin Care Center, Inc. DBA Clinical Science Institute
state: California
city: Coral Gables
country: United States
facility: Coral Gables Dermatology & Aesthetics
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education, LLC
state: Florida
city: Hialeah
country: United States
facility: Superior Associates in Research, LLC
state: Florida
city: Homestead
country: United States
facility: Homestead Associates in Research Inc
state: Florida
city: Miami
country: United States
facility: Genomics Medical Research
state: Florida
city: Miami
country: United States
facility: Med-Care Research
state: Florida
city: Atlanta
country: United States
facility: Dermatology Affiliates Research Institute, LLC
state: Georgia
city: Fayetteville
country: United States
facility: Javara Inc. / Privia Medical Group Georgia, LLC
state: Georgia
city: Thomasville
country: United States
facility: Mcintosh Clinic, PC
state: Georgia
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology PC
state: Michigan
city: Caledonia
country: United States
facility: The Derm Institute of West Michigan
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Columbia Falls
country: United States
facility: Central Missouri Dermatology Research, LLC
state: Montana
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology
state: New York
city: New York
country: United States
facility: Equity Medical
state: New York
city: Greensboro
country: United States
facility: The Moses H. Cone Memorial Hospital Operating Corporation
state: North Carolina
city: Hickory
country: United States
facility: Hickory Dermatology Research Center, LLC
state: North Carolina
city: Matthews
country: United States
facility: Javara Inc/ Tryon Medical Partners, PLLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Boardman
country: United States
facility: The Indiana Clinical Trials Center Optima Research Boardman
state: Ohio
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Columbia
country: United States
facility: Columbia Dermatology & Aesthetics
state: South Carolina
city: Goodlettsville
country: United States
facility: Goodlettsville Dermatology Research
state: Tennessee
city: Nashville
country: United States
facility: Belle Meade Dermatology Research
state: Tennessee
city: Nashville
country: United States
facility: Advanced Research Experts
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, inc.
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies, LTD. LLP
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research (AICR) - Pflugerville
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies, LTD. LLP
state: Texas
city: Bellevue
country: United States
facility: James Song, MD (James Song)
state: Washington
city: Cheyenne
country: United States
facility: Cheyenne Skin Clinic
state: Wyoming
city: Lovech
country: Bulgaria
facility: MC Medconsult-Lovech
city: Pleven
country: Bulgaria
facility: Medconsult Pleven
city: Sofia
country: Bulgaria
facility: Medical Centre Regina Life Clinic
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Yoanna-ISUL
city: Sofia
country: Bulgaria
facility: Diagnostic Consulatative Center
city: Tbilisi
country: Georgia
facility: JSC Curatio
city: Tbilisi
country: Georgia
facility: New Vision Univestiry Hospital
city: Tbilisi
country: Georgia
facility: Aversi Clinic
city: Tbilisi
country: Georgia
facility: David Abuladze Clinic (DAC)
city: Tbilisi
country: Georgia
facility: Raymann
city: Debrecen
country: Hungary
facility: University of Debrecen Dept of Dermatology
state: Hajdu-Bihar
city: Baross U 20.
country: Hungary
facility: Allergo-Derm Bakos Kft
city: Wroclaw
country: Poland
facility: Niepubliczny Zakladu Opieki Zdrowotnej MultiMedica s.c.
state: Dolnoslaskie
city: Lublin
country: Poland
facility: Luxderm Specjalistyczny Gabinet Dermatologiczny
state: Lubslskie
city: Krakow
country: Poland
facility: Centrum Medyczne \All-Med\ spolka komandytowa
state: Malopolska
city: Gdynia
country: Poland
facility: Miejski Szpital Zespolony
state: Pomorskie
city: Rzeszw
country: Poland
facility: Uniwersytecki Szpital Kliniczny, Klinika Dermatologii
state: Subcarpathian Voivodeship
city: Malbork
country: Poland
facility: "Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o"
state: Warminsko-Mazurskie
city: Bialystok-Podlaskie
country: Poland
facility: Zdrowie Osteo-Medic s.c.
city: Gdansk
country: Poland
facility: Care Access Gdansk
city: Katowice
country: Poland
facility: Care Access Holsamed Katowice
city: Krakow
country: Poland
facility: Lidia Rajzer-Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny
city: Lublin
country: Poland
facility: Clinical Best Solution Sp. z o.o Sp. k. w Lublinie
city: Warsaw
country: Poland
facility: Clinical Best Solutions SP. Z.O.O. SP.K.
city: Warszswa
country: Poland
facility: Klinika Ambroziak
Study officials:
References: