Efficacy and Safety of Telitacicept in Early SLE

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05899907

Collaborator

RemeGen Co., Ltd. (Industry)

180

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Systemic	Drug: Telitacicept Drug: Standard of Care	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Proportion of LLDAS in week 24 [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

Secondary Outcome Measures

Proportion of LLDAS in week 12 [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
Improvement in SLEDAI-2K [week 24 and 52]
Proportion of patients with SLEDAI-2K scores improvement ≥4 compared with baseline
Improvement in serological indices [week 24, 52]
Improvement in anti-dsDNA antibody titers, C3, C4, T cell and B cell subsets and IgG, IgA, IgM compared with baseline
Change in PGA [week 24, 52]
PGA: physician global assesment(0-3)
Number of participants with Adverse Events [up to week 52]
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.
Disease flare [up to week 52]
Proportion of patients suffer from SLE flare

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese Academy of Medical Sciences & Peking Union Medical College	Beijing	Beijing	China	100730
2	Peking University Third Hospital	Beijing		China
3	Fuyang People's Hospital	Fuyang		China
4	Guangdong Provincial People's Hospital	Guangzhou		China
5	Nanfang Hospital, Southern Medical University	Guanzhou		China
6	Qilu Hospital of Shandong University	Jinan		China
7	the First People's Hospital of Yunnan Province	Kunming		China
8	The Second Affiliated Hospital of Lanzhou University	Lanzhou		China
9	The Affiliated Hospital of Nantong University	Nantong		China
10	the Affiliated Hospital of Qingdao University	Qingdao		China
11	The Second Hospital of Hebei Medical University	Shijiazhuang		China
12	The First Affiliated Hospital of Soochow University	Suzhou		China
13	Shanxi Baiqiuen Hospital	Taiyuan		China
14	First Affiliated Hospital of Xinjiang Medical University	Urumqi		China
15	Weifang People's Hospital	Weifang		China
16	Tongji Hospital, Tongji Medical College,	Wuhan		China
17	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan		China
18	Wuxi Second People's Hospital	Wuxi		China
19	the First Affiliated Hospital of Xi'an Jiaotong University	Xi'an		China
20	The First Affiliated Hospital of Zhengzhou University	Zhenzhou		China

Sponsors and Collaborators

Peking Union Medical College Hospital
RemeGen Co., Ltd.

Investigators

Principal Investigator: Xiaomei Leng, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaomei Leng, Principal Investigator, Clinical Professor, Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT05899907

Other Study ID Numbers:

PUMCH-HS3345D

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xiaomei Leng, Principal Investigator, Clinical Professor, Peking Union Medical College Hospital

Lupus Erythematosus, Systemic

Telitacicept

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic

Study Results

No Results Posted as of Jun 12, 2023