Идёт набор NCT07311200

A Study of D-2570 in Patients With Active Systemic Lupus Erythematosus (SLE)

Фаза II С лечением Active Systemic Lupus Erythematosus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: D-2570, D-2570 Placebo.
Кому может быть актуально: Состояния в реестре: Active Systemic Lupus Erythematosus. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of D-2570 in Patients With Active Systemic Lupus Erythematosus

Обзор

This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of D-2570 in the treatment of active systemic lupus erythematosus.

Подробное описание

Subjects who sign the informed consent form will enter the screening period, during which their eligibility will be assessed according to the inclusion and exclusion criteria. Eligible participants who meet the inclusion criteria and do not meet any exclusion criteria will be randomized. Participants will then be assigned to one of the following groups: Group A, Group B, Group C, or the placebo group. They will proceed to the treatment period, during which they will take the corresponding investigational product once daily for 48 consecutive weeks. After completing the treatment, subjects will undergo safety follow-up. Throughout the treatment period, both investigators and subjects will remain blinded. During the study, participants will be required to provide pharmacokinetic and pharmacodynamic blood samples at the time points specified in the trial protocol.

Вмешательства

Препарат D-2570
Participants will be assigned to one of the following groups: Group A, Group B, Group C, or the placebo control group.
Препарат D-2570 Placebo
D-2570 Placebo

Первичные конечные точки

Proportion of subjects achieving the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 32 [Срок оценки: Week 32]

Вторичные конечные точки (12)

Proportion of subjects achieving SRI-4 at Weeks 4, 12, 24, and 48 [Срок оценки: Weeks 4, 12, 24, and 48]
Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index-6 (SRI-6) at Weeks 4, 12, 24, 32, and 48 [Срок оценки: Weeks 4, 12, 24, 32, and 48]
Improvement rate in the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score from baseline at Weeks 4, 12, 24, 32, and 48 [Срок оценки: Weeks 4, 12, 24, 32, and 48]
Proportion of subjects with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score improvement of ≥50% from baseline at Weeks 4, 12, 24, 32, and 48, among those with a baseline CLASI activity score of ≥10 [Срок оценки: Weeks 4, 12, 24, 32, and 48]
Proportion of subjects with ≥6 active (tender or swollen) joints at baseline who achieve a reduction of ≥50% in active (tender or swollen) joint count from baseline at Weeks 4, 12, 24, 32, and 48 [Срок оценки: Weeks 4, 12, 24, 32, and 48]
Proportion of subjects achieving the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Weeks 4, 12, 24, 32, and 48 [Срок оценки: Weeks 4, 12, 24, 32, and 48]
Proportion of subjects achieving Lupus Low Disease Activity State (LLDAS) at Weeks 4, 12, 24, 32, and 48 [Срок оценки: Weeks 4, 12, 24, 32, and 48]
Proportion of subjects with a prednisone dose of ≤5.0 mg/day or a reduction of ≥25% from baseline dose during Weeks 44-48 [Срок оценки: Weeks 44-48]
Changes from baseline of anti-double-stranded DNA (dsDNA) antibody [Срок оценки: From enrollment to the end of treatment at 48 weeks]
blood drug concentration of D-2570 [Срок оценки: From enrollment to the end of treatment at 48 weeks]
Incidence of adverse events rate based on NCI CTCAE V5.0 [Срок оценки: From enrollment to 52 weeks]
Changes from baseline of complement (C3) levels [Срок оценки: From enrollment to the end of treatment at 48 weeks]

Критерии участия

Критерии включения

The patient voluntarily participates in this study after full informed consent.
The age is 18 years ≤ age ≤ 70 years, regardless of gender.
Diagnosed with Systemic Lupus Erythematosus (SLE) at least ≥ 24 weeks prior to screening.
SLEDAI-2K total score ≥ 8.
On stable treatment for systemic lupus erythematosus at least 4 weeks prior to randomization, and should remain at a stable dose throughout the trial period.