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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Active Systemic Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A: D-2570 and placebo

Group Type EXPERIMENTAL

D-2570

Intervention Type DRUG

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

D-2570 Placebo

Intervention Type DRUG

D-2570 Placebo

Group B: D-2570 and placebo

Group Type EXPERIMENTAL

D-2570

Intervention Type DRUG

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

D-2570 Placebo

Intervention Type DRUG

D-2570 Placebo

Group C: D-2570

Group Type EXPERIMENTAL

D-2570

Intervention Type DRUG

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

Placebo Control Group

Group Type PLACEBO_COMPARATOR

D-2570 Placebo

Intervention Type DRUG

D-2570 Placebo

Interventions

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D-2570

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

Intervention Type DRUG

D-2570 Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* History of infection as defined in the protocol.
* Any of the medical diseases or disorders listed in the protocol.
* Significant, uncontrolled or unstable disease in any organ.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No