Evaluating Telitacicept for Early Systemic Lupus Erythematosus

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

This study is testing if a new drug called Telitacicept can help adults with early-stage systemic lupus erythematosus feel better compared to standard care.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: belimumab, Cyclophosphamide, Prednisone
• Locations: 20 sites (Beijing, Beijing and 19 other locations)
• Trial ID: NCT05899907 on ClinicalTrials.gov

What this trial studies

This phase 4, multicenter, randomized, double-blind, open-label study aims to assess the safety and efficacy of Telitacicept in adult patients diagnosed with early-stage systemic lupus erythematosus (SLE), defined as having a disease duration of less than two years. Participants will receive either Telitacicept or standard care while being closely monitored for treatment outcomes. The study will include patients aged 18-65 who meet specific clinical criteria for SLE and will evaluate their response to the treatment over a defined period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a clinical diagnosis of early-stage systemic lupus erythematosus and specific laboratory findings.

Not a fit: Patients with severe lupus nephritis or those requiring immediate aggressive treatment for neuropsychiatric symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with early-stage systemic lupus erythematosus.

How similar studies have performed: Other studies have shown promise in treating systemic lupus erythematosus with similar biologic approaches, indicating potential for success.

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

Where this trial is running

Beijing, Beijing and 19 other locations

• Chinese Academy of Medical Sciences & Peking Union Medical College — Beijing, Beijing, 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 — Urumqi, 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)

Study contacts

• Principal investigator: Xiaomei Leng — Peking Union Medical College Hospital
• Study coordinator: Xiaomei Leng

Conditions Lupus Erythematosus, Systemic; Telitacicept