Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients

Summary

Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with abnormal activation of B lymphocytes, which may result in many adverse consequences and even death if not treated actively. Telitacicept, approved conditionally in China in March 2021, is a biologic agent targeting B lymphocyte stimulator (BLyS）and a proliferating inducing ligand (APRIL) dually for patients with active SLE patients who have not responded to conventional treatment. The investigators hope to screen predictive biomarkers of efficacy and explore the mechanism of difference in efficacy of Telitacicept with Chinese characteristics by omics.

Conditions

• Systemic Lupus Erythematosus

Interventions

BIOLOGICAL

Telitacicept

It is necessary and will be given by subcutaneous injection of 160mg/week for 24 weeks.

DRUG

Hydroxychloroquine

It is necessary and will be given by oral administration of 0.2g/day for 24 weeks.

DRUG

Prednisone

It is permitted which can be interchangeable with methylprednisolone. It will be given by oral administration of 30mg/day from beginning and be lowed dosage during the treatment of 24 weeks.

DRUG

Methylprednisolone

It is permitted which can be interchangeable with prednisone. It will be given by oral administration of 24mg/day from beginning and be lowed dosage during the treatment of 24 weeks.

DRUG

Cyclophosphamide

It is permitted which can be interchangeable with mycophenolate mofetil or tacrolimus. It will be given by oral administration of 0.8g/month for 24 weeks.

DRUG

Mycophenolate Mofetil

It is permitted which can be interchangeable with cyclophosphamide or tacrolimus. It will be given by oral administration of 0.5g twice a day for 24 weeks.

DRUG

Tacrolimus

It is permitted which can be interchangeable with cyclophosphamide or mycophenolate mofetil. It will be given by oral administration of 1mg twice a day for 24 weeks.

Sponsors & Collaborators

• Fen Li

  lead OTHER

Principal Investigators

• Fen Li, doctor · Central South University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-31

Primary Completion

2024-06-30

Completion

2024-06-30

FDA Drug

Yes

Countries

• China

Study Locations