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

Phase 2

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Telitacicept; Drug: conventional therapy; Drug: Placebo

• Registration Number: NCT05929248
• Lead Sponsor: Guanmin Gao

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-26
• Last Update Submitted: 2023-06-26
• Study Start: 2023-07-01
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Telitacicept	conventional treatment plus Telitacicept 160 mg sc per week
Treatment group	conventional therapy	conventional treatment plus Telitacicept 160 mg sc per week
Control group	conventional therapy	Placebo plus conventional treatment
Control group	Placebo	Placebo plus conventional treatment

Primary Outcome Measures

Name	Time	Method
The remission rate of SLE response index at month 12 of treatment	months 12	Use SRI-4 to represent the response index, with a higher response rate indicating better drug efficacy
Improvement in platelet count	months 12	Platelet count at month of treatment，Increased platelet count indicates improvement in disease

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with a decrease of ≥ 4 points in the SELENA-SLEDAI score from baseline at months 6 and 12	months 6 and 12	A decrease of ≥ 4 points from baseline in the SELENA-SLEDAI score indicates a good drug response effect
Hormone reduction	month 12	Changes in patient hormone dose from baseline at month 12，reduced hormone dosage indicates improvement in disease
B lymphocyte count	month 12	Changes in patient B lymphocyte count from baseline at month 12