NCT05929248

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

June 14, 2023

Last Update Submit

June 26, 2023

Conditions

Systemic Lupus Erythematosus

Keywords

lupus erythematosusTelitaciceptthrombocytopenia

Outcome Measures

Primary Outcomes (2)

  • 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

    months 12

  • Improvement in platelet count

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

    months 12

Secondary Outcomes (3)

  • 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

  • Hormone reduction

    month 12

  • B lymphocyte count

    month 12

Study Arms (2)

Treatment group

EXPERIMENTAL

conventional treatment plus Telitacicept 160 mg sc per week

Drug: TelitaciceptDrug: conventional therapy

Control group

PLACEBO COMPARATOR

Placebo plus conventional treatment

Drug: conventional therapyDrug: Placebo

Interventions

TelitaciceptDRUG

160mg once a week for 48 weeks

Also known as: RC18
Treatment group
conventional therapyDRUG

Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

Control groupTreatment group
PlaceboDRUG

Used once a week in combination with standard treatment

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • \. Sign informed documents.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lupus Erythematosus, SystemicThrombocytopenia

Interventions

telitacicept

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Officials

  • Gao Guanmin

    The First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao Guanmin

CONTACT

13613716851Guanmingao@zzu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

June 14, 2023

First Posted

July 3, 2023

Study Start

July 1, 2023

Primary Completion

June 30, 2024

Study Completion

December 30, 2024

Last Updated

July 3, 2023

Record last verified: 2023-06