Health TrialsbyHealthPanel

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

ConditionActive Systemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInventisBio Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • D-2570

    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

    Drug

    D-2570 Placebo

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Group A: D-2570 and placeboExperimental treatment 2 interventions
Group B: Group B: D-2570 and placeboExperimental treatment 2 interventions
Group C: Group C: D-2570Experimental treatment 1 intervention
Group D: Placebo Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of subjects achieving the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 32

Time frame
Week 32

Secondary outcomes

1

Proportion of subjects achieving SRI-4 at Weeks 4, 12, 24, and 48

Time frame
Weeks 4, 12, 24, and 48
2

Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index-6 (SRI-6) at Weeks 4, 12, 24, 32, and 48

Time frame
Weeks 4, 12, 24, 32, and 48
3

Improvement rate in the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score from baseline at Weeks 4, 12, 24, 32, and 48

Time frame
Weeks 4, 12, 24, 32, and 48
4

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

Time frame
Weeks 4, 12, 24, 32, and 48

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Linfen Central HospitalRecruiting Linfen, JiangxiChinaChina

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

InventisBio Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
Apply now