Efficacy and Safety of Telitacicept in Early SLE

A Study of Telitacicept in the Treatment of Early Stage Systemic Lupus Erythematosus

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

Study Overview

• Status: Recruiting
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Drug: Telitacicept; Drug: Standard of Care

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiaomei Leng; Phone Number: +8613681057089; Email: lpumch@126.com

Study Locations

• China
  • Beijing, China
    • Active, not recruiting
    • Peking University Third Hospital
  • Fuyang, China
    • Active, not recruiting
    • Fuyang People's Hospital
  • Guangzhou, China
    • Active, not recruiting
    • Guangdong Provincial People's Hospital
  • Guanzhou, China
    • Active, not recruiting
    • Nanfang Hospital, Southern Medical University
  • Jinan, China
    • Active, not recruiting
    • Qilu Hospital of Shandong University
  • Kunming, China
    • Active, not recruiting
    • The First People's Hospital of Yunnan Province
  • Lanzhou, China
    • Active, not recruiting
    • The Second Affiliated Hospital of Lanzhou University
  • Nantong, China
    • Active, not recruiting
    • The Affiliated Hospital of Nantong University
  • Qingdao, China
    • Active, not recruiting
    • The Affiliated Hospital of Qingdao University
  • Shijiazhuang, China
    • Active, not recruiting
    • The Second Hospital of Hebei Medical University
  • Suzhou, China
    • Active, not recruiting
    • The First Affiliated Hospital of Soochow University
  • Taiyuan, China
    • Active, not recruiting
    • Shanxi Baiqiuen Hospital
  • Urumqi, China
    • Active, not recruiting
    • First Affiliated Hospital of Xinjiang Medical University
  • Weifang, China
    • Active, not recruiting
    • Weifang People's Hospital
  • Wuhan, China
    • Active, not recruiting
    • Tongji Hospital, Tongji Medical College,
  • Wuhan, China
    • Active, not recruiting
    • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wuxi, China
    • Active, not recruiting
    • Wuxi Second People's Hospital
  • Xi'an, China
    • Active, not recruiting
    • The First Affiliated Hospital of Xi'an Jiaotong University
  • Zhenzhou, China
    • Active, not recruiting
    • The First Affiliated Hospital of Zhengzhou University
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Chinese Academy of Medical Sciences & Peking Union Medical College
      • Principal Investigator: Xiaofeng Zeng
      • Contact: Xiaomei Leng; Phone Number: +8613681057089; Email: lpumch@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Telitacicept; 160mg once a week for 48 weeks; Other Names: RC18; Drug: Standard of Care; Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
Other: Control group; Standard of care	Drug: Standard of Care; Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of LLDAS in week 24	Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials	week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of LLDAS in week 12	Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials	week 12
Improvement in SLEDAI-2K	Proportion of patients with SLEDAI-2K scores improvement ≥4 compared with baseline	week 24 and 52
Improvement in serological indices	Improvement in anti-dsDNA antibody titers, C3, C4, T cell and B cell subsets and IgG, IgA, IgM compared with baseline	week 24, 52
Change in PGA	PGA: physician global assesment(0-3)	week 24, 52
Number of participants with Adverse Events	An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose resulting in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant and which the investigator regards as serious based on appropriate medical judgment.	up to week 52
Disease flare	Proportion of patients suffer from SLE flare	up to week 52

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: RemeGen Co., Ltd.
• Investigators: Principal Investigator: Xiaomei Leng, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Lupus Erythematosus, Systemic; Telitacicept
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: PUMCH-HS3345D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No