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

InventisBio

Status and phase: Not yet enrolling; Phase 2

Conditions: Active Systemic Lupus Erythematosus

Treatments: Drug: D-2570; Drug: D-2570 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07311200

D2570-205

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

Group A: D-2570 and placebo

Experimental group

Treatment:

Drug: D-2570 Placebo

Drug: D-2570

Group B: D-2570 and placebo

Experimental group

Treatment:

Drug: D-2570 Placebo

Drug: D-2570

Group C: D-2570

Experimental group

Treatment:

Drug: D-2570

Placebo Control Group

Placebo Comparator group

Treatment:

Drug: D-2570 Placebo