Exploring the Therapeutic Effect of Telitacicept on Lupus Erythematosus Complicated With Thrombocytopenia

Guanmin Gao

Status and phase: Not yet enrolling; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Placebo; Drug: conventional therapy; Drug: Telitacicept

Study type: Interventional

Funder types: Other

Identifiers

NCT05929248

GGao

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus and refractory thrombocytopenia

Full description

This study is a single center, randomized, controlled trial to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus complicated with refractory thrombocytopenia.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meets the 2012 ACR revised standards and meets four or more diagnostic criteria for systemic lupus erythematosus;

2. Refractory thrombocytopenia (defined as receiving at least one course of methylprednisolone pulse therapy or intravenous injection of high-dose immunoglobulin or high-dose glucocorticoid combined with two or more Immunosuppressive drug failed and did not respond to any single drug);

3. SLEENA-SLEDAI score is greater than or equal to 8 points. If anti ds-DNA antibody is positive and/or low complement, SLEENA-SLEDAI score is greater than or equal to 6 points, or PLT count is<10 * 10 ^ 9/L or<30 * 10 ^ 9/L with bleeding tendency;

4. Age greater than or equal to 18 years old and less than or equal to 65 years old;

5. Have a stable SLE treatment plan, and participants should receive standard treatment for at least 30 days before randomization; 6. Positive Antinuclear antibody or anti ds DNA antibody;

6. Sign informed documents.

Exclusion criteria

Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria:

1. Patients who are allergic to tamoxifen;
2. Patients with severe active infection, history of tuberculosis, malignant tumor, HIV, hepatitis B, hepatitis C, important organs or hematopoietic stem cells/cells/bone marrow transplantation or kidney transplantation;
3. Patients with severe active central nervous system lupus and severe active lupus nephritis
4. Patients with diseases of liver, kidney, heart and other important organs, blood and Endocrine system;
5. Pregnant and lactating women;
6. Have a pregnancy preparation plan in the past year;
7. Those who have merged with other autoimmune diseases;
8. Incomplete case data and missing persons.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

conventional treatment plus Telitacicept 160 mg sc per week

Treatment:

Drug: Telitacicept

Drug: conventional therapy

Control group

Placebo Comparator group

Description:

Placebo plus conventional treatment

Treatment:

Drug: conventional therapy

Drug: Placebo