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

• ClinicalTrials.gov Identifier: NCT05929248
• Recruitment Status: Not yet recruiting
• First Posted: July 3, 2023
• Last Update Posted: July 3, 2023
• Sponsor: Guanmin Gao
• Information provided by (Responsible Party): Guanmin Gao, The First Affiliated Hospital of Zhengzhou University

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 (Clinical Trial)
• Estimated 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
• Estimated Study Start Date: July 1, 2023
• Estimated Primary Completion Date: June 30, 2024
• Estimated Study Completion Date: December 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 Name: 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 [ Time Frame: months 12 ]
   Use SRI-4 to represent the response index, with a higher response rate indicating better drug efficacy
2. Improvement in platelet count [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: month 12 ]
   Changes in patient hormone dose from baseline at month 12，reduced hormone dosage indicates improvement in disease
3. B lymphocyte count [ Time Frame: month 12 ]
   Changes in patient B lymphocyte count from baseline at month 12

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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;

7. 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

Contacts

Contact: Gao Guanmin; 13613716851; Guanmingao@zzu.edu.cn

Sponsors and Collaborators

Guanmin Gao

Investigators

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

More Information

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guanmin Gao, The First Affiliated Hospital of Zhengzhou University:

lupus erythematosus; Telitacicept; thrombocytopenia

Additional relevant MeSH terms:

Thrombocytopenia; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Blood Platelet Disorders; Hematologic Diseases; Cytopenia