NCT05899907

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2022

Typical duration for phase_4

Geographic Reach
1 country

20 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

2.5 years

First QC Date

March 26, 2023

Last Update Submit

June 1, 2023

Conditions

Lupus Erythematosus, Systemic

Keywords

Lupus Erythematosus, SystemicTelitacicept

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Proportion of LLDAS in week 12

    week 12

  • Improvement in SLEDAI-2K

    week 24 and 52

  • Improvement in serological indices

    week 24, 52

  • Change in PGA

    week 24, 52

  • Number of participants with Adverse Events

    up to week 52

  • +1 more secondary outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

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: TelitaciceptDrug: Standard of Care

Control group

OTHER

Standard of care

Drug: Standard of Care

Interventions

TelitaciceptDRUG

160mg once a week for 48 weeks

Also known as: RC18
Treatment group
Standard of CareDRUG

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

Control groupTreatment group

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of SLE according to the 1997 American College of Rheumatology (ACR) classification criteria or 2019 EULAR/ACR classification criteria
  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

RECRUITING

Peking University Third Hospital

Beijing, China

ACTIVE NOT RECRUITING

Fuyang People's Hospital

Fuyang, China

ACTIVE NOT RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, China

ACTIVE NOT RECRUITING

Nanfang Hospital, Southern Medical University

Guanzhou, China

ACTIVE NOT RECRUITING

Qilu Hospital of Shandong University

Jinan, China

ACTIVE NOT RECRUITING

the First People's Hospital of Yunnan Province

Kunming, China

ACTIVE NOT RECRUITING

The Second Affiliated Hospital of Lanzhou University

Lanzhou, China

ACTIVE NOT RECRUITING

The Affiliated Hospital of Nantong University

Nantong, China

ACTIVE NOT RECRUITING

the Affiliated Hospital of Qingdao University

Qingdao, China

ACTIVE NOT RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, China

ACTIVE NOT RECRUITING

Shanxi Baiqiuen Hospital

Taiyuan, China

ACTIVE NOT RECRUITING

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, China

ACTIVE NOT RECRUITING

Weifang People's Hospital

Weifang, 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

Wuhan, China

ACTIVE NOT RECRUITING

Wuxi Second People's Hospital

Wuxi, China

ACTIVE NOT RECRUITING

the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhenzhou, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

telitaciceptStandard of Care

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Xiaomei Leng

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomei Leng

CONTACT

+8613681057089lpumch@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

March 26, 2023

First Posted

June 12, 2023

Study Start

September 1, 2022

Primary Completion

March 1, 2025

Study Completion

September 1, 2025

Last Updated

June 12, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(20)