Език: EN EN
← Назад към резултатите
Набира участници Фаза 2 NCT07474792

Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Plaque Psoriasis

Спонсор: Oruka Therapeutics, Inc.

Налично на: БГ
Обобщение
This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-002 in adult participants with moderate-to-severe plaque psoriasis.
Описание
This is a multicenter, randomized, double-blinded, placebo-controlled, dose range finding study designed to identify the optimal induction dosing regimen of ORKA-002 in approximately 160 adult participants with moderate-to-severe plaque psoriasis. The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-002 compared to placebo. The study will consist of 3 periods: * Screening Period * Induction Period * Post-treatment Follow-up Period
Кой може да участва
Inclusion Criteria: 1. Participants ≥ 18 and \< 80 years of age at the time of consent 2. Have a diagnosis of plaque psoriasis for \> 6 months 3. Have moderate-to-severe chronic plaque psoriasis defined as: 1. BSA ≥ 10%, and 2. PASI ≥ 12, and 3. IGA score of ≥ 3 on a 5-point scale 4. Candidate for systemic therapy or phototherapy 5. Women of childbearing potential must have a negative pregnancy test Exclusion Criteria: 1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis) 2. Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease 3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence 4. A known hypersensitivity to any components of the ORKA-002 drug product 5. Women who are breastfeeding or plan to breastfeed during the study
Интервенции
ORKA-002
DRUG
Placebo
OTHER
Места на провеждане 27
Канада (9)
SimcoDerm Medical and Surgical Dermatology Centre
Barrie , Ontario
Alberta DermaSurgery Centre
Edmonton , Alberta
Laser Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton , Alberta
DermEffects
London , Ontario
North Bay Dermatology Centre Inc.
North Bay , Ontario
SKiN Centre for Dermatology
Peterborough , Ontario
Dr. Chih-ho Hong Medical Inc
Surrey , British Columbia
Toronto Research Centre Inc.
Toronto , Ontario
Alliance Clinical Trials Inc.
Waterloo , Ontario
САЩ (18)
Bexley Dermatology Research
Bexley , Ohio
Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
Birmingham , Alabama
Driven Research LLC
Coral Gables , Florida
Central Connecticut Dermatology Research, PLLC
Cromwell , Connecticut
Modern Research Associates, PLLC
Dallas , Texas
Henry Ford Medical Center
Detroit , Michigan
First OC Dermatology Research, Inc.
Fountain Valley , California
Kuchnir Dermatology & Dermatologic Surgery
Milford , Massachusetts
Frontier Derm Partners CRO LLC
Mill Creek , Washington
Associated Skin Care Specialists, PA d/b/a Minnesota Clinical Study Center
New Brighton , Minnesota
Icahn School of Medicine at Mount Sinai, Department of Dermatology
New York , New York
Skin Specialists, PC dba Schlessinger MD
Omaha , Nebraska
TCR Medical Corporation
San Diego , California
Southern California Clinical Research
Santa Ana , California
Institute of Clinical Research and Consulting, Inc., d/b/a Clinical Science Institute
Santa Monica , California
Grekin Skin Institute
Warren , Michigan
Clear Choice Dermatology LLC
Warrenton , Oregon
WDC Cosmetic and Research, PLLC
Wilmington , North Carolina
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
79 Years
Здрави доброволци
Не
Начална дата
19.03.2026
Крайна дата
01.04.2029
Регистрационен номер
NCT07474792
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.