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Набира участници Фаза 2 NCT07315061

A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis

Фаза 2 – изследване на ефективността и дозировката
Заболявания: PsA (Psoriatic Arthritis)

Спонсор: InventisBio Co., Ltd

Налично на: БГ
Обобщение
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The target population is patients with active psoriatic arthritis. A total of 222 subjects are planned to be included.
Описание
The study is divided into three groups, each will include 74 subjects. The primary difference among the three groups lay in the dosage and whether they were placebo groups or not. In other aspects, such as population selection, randomization, blinding and outcome evaluation (safety and efficacy), are consistent among the three groups.
Кой може да участва
Inclusion Criteria: 1. Subjects voluntarily take part in the study after being fully informed, sign a written informed consent form (ICF), and agree to follow procedures specified in the study protocol; 2. Males and females, 18 to 70 years of age, inclusive at the time of signing of ICF; 3. Have had an psoriatic arthritis of ≥ 3 months in duration prior to signing of ICF; 4. Have had active arthritis, characterized by at least ≥3 tender joints (68 joint tenderness counts) and ≥3 swollen joints (66 joint swelling counts). Exclusion Criteria: 1. History of infection as defined in the protocol; 2. Any of the medical diseases or disorders listed in the protocol; 3. Significant, uncontrolled or unstable disease in any organ.
Интервенции
D-2570
DRUG
Placebo
DRUG
Места на провеждане 1
Китай (1)
West China School of Medicine
Chengdu , Sichuan
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
70 Years
Здрави доброволци
Не
Начална дата
16.01.2026
Крайна дата
06.08.2028
Регистрационен номер
NCT07315061
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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