Clinical trial NCT05899907: Efficacy and Safety of Telitacicept in Early SLE
Official title: A Study of Telitacicept in the Treatment of Early Stage Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Lupus Erythematosus, Systemic
Keywords: Lupus Erythematosus, Systemic
Telitacicept
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: RemeGen Co., Ltd.
First posted: 2023-06-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of LLDAS in week 24
timeFrame: week 24
Secondary outcomes:
measure: Proportion of LLDAS in week 12
timeFrame: week 12
measure: Improvement in SLEDAI-2K
timeFrame: week 24 and 52
measure: Improvement in serological indices
timeFrame: week 24, 52
measure: Change in PGA
timeFrame: week 24, 52
measure: Number of participants with Adverse Events
timeFrame: up to week 52
measure: Disease flare
timeFrame: up to week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences & Peking Union Medical College
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
city: Fuyang
country: China
facility: Fuyang People's Hospital
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guanzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Kunming
country: China
facility: the First People's Hospital of Yunnan Province
city: Lanzhou
country: China
facility: The Second Affiliated Hospital of Lanzhou University
city: Nantong
country: China
facility: The Affiliated Hospital of Nantong University
city: Qingdao
country: China
facility: the Affiliated Hospital of Qingdao University
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Taiyuan
country: China
facility: Shanxi Baiqiuen Hospital
city: Urumqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
city: Weifang
country: China
facility: Weifang People's Hospital
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College,
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Wuxi
country: China
facility: Wuxi Second People's Hospital
city: Xi'an
country: China
facility: the First Affiliated Hospital of Xi'an Jiaotong University
city: Zhenzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xiaomei Leng
role: PRINCIPAL_INVESTIGATOR
References: