Efficacy and Safety of Telitacicept in Early SLE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-09-01

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with early stage of SLE .

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Detailed Description

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This is a phase 4, multicentre, randomised, double-blind, open-labeled study to evaluate the efficacy and safety of telitacicept in adult subjects with active early stage of SLE (disease duration less than 2 years).

Conditions

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Lupus Erythematosus, Systemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Standard of care plus Telitacicept 160 mg sc per week; after week 12, the dose can be reduced to 80 mg per week due to safety considerations.

Group Type EXPERIMENTAL

Telitacicept

Intervention Type DRUG

160mg once a week for 48 weeks

Standard of Care

Intervention Type DRUG

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

Control group

Standard of care

Group Type OTHER

Standard of Care

Intervention Type DRUG

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

Interventions

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Telitacicept

160mg once a week for 48 weeks

Intervention Type DRUG

Standard of Care

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

Intervention Type DRUG

Other Intervention Names

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RC18

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of SLE according to the 1997 American College of Rheumatology (ACR) classification criteria or 2019 EULAR/ACR classification criteria
* 18-65 years of age
* body weight 45-90kg
* antinuclear antibody titers ≥1:80, and/ or anti-double-stranded DNA antibodies
* SLEDAI-2K score ≥8 scores
* Disease duration less than 2 years (defined as the duration between the first appearance of any symptom/sign attributed to SLE and baseline)
* A stantard therapy for at least 30d for patients who are not treatment-naive
* Negative pregnancy test for child-bearing women at screening and baseline
* Provide written informed consent

Exclusion Criteria

* Known to be allergic to Prednisone Acetate, Meprednisone, Hydroxychloroquine, and Immunosuppressants including Mycophenolate Mofetil, Cyclophosphamide,et al
* Active serious neuropsychiatric systemic lupus erythematosus or other severe situations of SLE who need pulse steroid treatment
* severe lupus nephritis: 24hUP more than 6g, serum creatinine \> 221umol/L
* History of severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis) requiring intervention within 60 days of baseline (Day 1)
* Abnormal liver function (ALT or AST is 2 times higher than normal)
* Baseline IgG below the lower limit of the normal range
* Pregnancy or breastfeeding women
* Have a history of malignant tumors
* Have any serious acute, chronic or recurrent infectious disease (such as pneumonia or active stage of pyelitis, recurrent pneumonia, chronic bronchiectasis and tuberculosis)
* Chronic infections, such as Hepatitis B virus or hepatitis B and C and HIV
* Cardiac insufficiency with metabolic imbalance or severe high blood pressure (systolic pressure \> 160mmHg or diastolic pressure \> 100mmHg) or diabetics
* Active hemorrhage or peptic ulcer
* With other concommitant autoimmune disease;
* Receipt of B-cell-targeted therapy (including belimumab) within 1 year before randomization
* Receipt of IVIG within 28 days before randomization
* Receipt of TNF inhibitor, IL-1R inhibitor or plasma exchange therapy within 90 days before randomization
* Participated in other drugs clinical trials within 4 weeks.
* Receipt of live vaccine within 4 weeks before randomization
* Receipt of COVID-19 vaccine within 4 weeks before randomization
* Subjects who in the opinion of the investigator are not suitable to participate

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Xiaomei Leng

Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaomei Leng

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status RECRUITING