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

Primary Purpose

Systemic Lupus Erythematosus

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Telitacicept
conventional therapy
Placebo
Sponsored by
Guanmin Gao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring lupus erythematosus, Telitacicept, thrombocytopenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets the 2012 ACR revised standards and meets four or more diagnostic criteria for systemic lupus erythematosus; 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); 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; Age greater than or equal to 18 years old and less than or equal to 65 years old; 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: Patients who are allergic to tamoxifen; 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; Patients with severe active central nervous system lupus and severe active lupus nephritis Patients with diseases of liver, kidney, heart and other important organs, blood and Endocrine system; Pregnant and lactating women; Have a pregnancy preparation plan in the past year; Those who have merged with other autoimmune diseases; Incomplete case data and missing persons.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Treatment group

    Control group

    Arm Description

    conventional treatment plus Telitacicept 160 mg sc per week

    Placebo plus conventional treatment

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 14, 2023
    Last Updated
    June 26, 2023
    Sponsor
    Guanmin Gao
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05929248
    Brief Title
    Exploring the Therapeutic Effect of Telitacicept on Lupus Erythematosus Complicated With Thrombocytopenia
    Official Title
    A Randomized Controlled Trial Aimed at Exploring the Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus Patients With Refractory Thrombocytopenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Guanmin Gao

    4. Oversight

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

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Lupus Erythematosus
    Keywords
    lupus erythematosus, Telitacicept, thrombocytopenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group
    Arm Type
    Experimental
    Arm Description
    conventional treatment plus Telitacicept 160 mg sc per week
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo plus conventional treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Telitacicept
    Other Intervention Name(s)
    RC18
    Intervention Description
    160mg once a week for 48 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    conventional therapy
    Intervention Description
    Steroid(≤1mg/kg/d) with or without proper immunosuppressants:CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Used once a week in combination with standard treatment
    Primary Outcome Measure Information:
    Title
    The remission rate of SLE response index at month 12 of treatment
    Description
    Use SRI-4 to represent the response index, with a higher response rate indicating better drug efficacy
    Time Frame
    months 12
    Title
    Improvement in platelet count
    Description
    Platelet count at month of treatment,Increased platelet count indicates improvement in disease
    Time Frame
    months 12
    Secondary Outcome Measure Information:
    Title
    Percentage of patients with a decrease of ≥ 4 points in the SELENA-SLEDAI score from baseline at months 6 and 12
    Description
    A decrease of ≥ 4 points from baseline in the SELENA-SLEDAI score indicates a good drug response effect
    Time Frame
    months 6 and 12
    Title
    Hormone reduction
    Description
    Changes in patient hormone dose from baseline at month 12,reduced hormone dosage indicates improvement in disease
    Time Frame
    month 12
    Title
    B lymphocyte count
    Description
    Changes in patient B lymphocyte count from baseline at month 12
    Time Frame
    month 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meets the 2012 ACR revised standards and meets four or more diagnostic criteria for systemic lupus erythematosus; 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); 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; Age greater than or equal to 18 years old and less than or equal to 65 years old; 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: Patients who are allergic to tamoxifen; 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; Patients with severe active central nervous system lupus and severe active lupus nephritis Patients with diseases of liver, kidney, heart and other important organs, blood and Endocrine system; Pregnant and lactating women; Have a pregnancy preparation plan in the past year; Those who have merged with other autoimmune diseases; Incomplete case data and missing persons.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gao Guanmin
    Phone
    13613716851
    Email
    Guanmingao@zzu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gao Guanmin
    Organizational Affiliation
    The First Affiliated Hospital of Zhengzhou University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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