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

• Sponsor: Guanmin Gao (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05929248
• Collaborator: (none)
• Enrollment: 64
• Arms: 2
• Anticipated Duration (Months): 18

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: Telitacicept; Drug: conventional therapy; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial Aimed at Exploring the Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus Patients With Refractory Thrombocytopenia
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group conventional treatment plus Telitacicept 160 mg sc per week	Drug: Telitacicept; 160mg once a week for 48 weeks; Other Names: RC18 ; Drug: conventional therapy; Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
Placebo Comparator: Control group Placebo plus conventional treatment	Drug: conventional therapy; Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.; Drug: Placebo; Used once a week in combination with standard treatment

Outcome Measures

Primary Outcome Measures

1. 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

2. Improvement in platelet count [months 12]

   Platelet count at month of treatment，Increased platelet count indicates improvement in disease

Secondary Outcome Measures

1. 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

2. Hormone reduction [month 12]

   Changes in patient hormone dose from baseline at month 12，reduced hormone dosage indicates improvement in disease

3. B lymphocyte count [month 12]

   Changes in patient B lymphocyte count from baseline at month 12

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Guanmin Gao

Investigators

• Principal Investigator: Gao Guanmin, The First Affiliated Hospital of Zhengzhou University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guanmin Gao, chief physician, The First Affiliated Hospital of Zhengzhou University
• ClinicalTrials.gov Identifier: NCT05929248
• Other Study ID Numbers: GGao
• First Posted: Jul 3, 2023
• Last Update Posted: Jul 3, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Guanmin Gao, chief physician, The First Affiliated Hospital of Zhengzhou University: lupus erythematosus; Telitacicept; thrombocytopenia
• Additional relevant MeSH terms: Thrombocytopenia; Lupus Erythematosus, Systemic

Study Results

No Results Posted as of Jul 3, 2023