Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus
NCT ID: NCT05339217
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2023-02-07
2025-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Telitacicept in Early SLE
NCT05899907
Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus
NCT05247203
Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE)
NCT06458972
Effect of Telitacicept on Transitional Regulatory B Cells in Patients With Systemic Lupus Erythematosus
NCT06137053
Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients
NCT05666336
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Telitacicept and low dose IL2
160mg Telitacicept was subcutaneously injected to patients with systemic lupus erythematosus at the outer side of upper arm every week for 24 weeks.
Interleukine-2 was first added to the original treatment for systemic lupus erythematosus with 1 million IU qod for 12 weeks, injected subcutaneously at the outer side of upper arm, abdomen and thigh, then the same dose of IL2 was injected once a week for 12 weeks subcutaneously.
Telitacicept
160mg Telitacicept was subcutaneously injected to patients with systemic lupus erythematosus at the outer side of upper arm every week for 24 weeks.
Interleukin-2
Low lose interleukine-2 at a dose of 1 million IU was injected once every other day for 12 weeks, then the same dose of IL2 was injected once a week at the second stage for 12 weeks.
Telitacicept
160mg Telitacicept was subcutaneously injected to patients with systemic lupus erythematosus at the outer side of upper arm every week for 24 weeks.
Telitacicept
160mg Telitacicept was subcutaneously injected to patients with systemic lupus erythematosus at the outer side of upper arm every week for 24 weeks.
low dose IL2
Interleukine-2 was first added to the original treatment for systemic lupus erythematosus with 1 million IU qod for 12 weeks, injected subcutaneously at the outer side of upper arm, abdomen and thigh, then the same dose of IL2 was injected once a week for 12 weeks subcutaneously.
Interleukin-2
Low lose interleukine-2 at a dose of 1 million IU was injected once every other day for 12 weeks, then the same dose of IL2 was injected once a week at the second stage for 12 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Telitacicept
160mg Telitacicept was subcutaneously injected to patients with systemic lupus erythematosus at the outer side of upper arm every week for 24 weeks.
Interleukin-2
Low lose interleukine-2 at a dose of 1 million IU was injected once every other day for 12 weeks, then the same dose of IL2 was injected once a week at the second stage for 12 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients meet the American-European Consensus Group 2002 classification criteria of SLE.
3. The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols.
4. Dosing of antimalarials, prednisone or equivalent, cholinergic stimulants, and topical cyclosporine required to be stable for at least 4 weeks before screening and during study; maximum doses allowed:
* Hydroxychloroquine, 400 mg/day;
* Prednisone, 10 mg/day
Exclusion Criteria
1. Laboratory abnormality: • Hb≤9 g/dl • Neutrophil 10 mg/d) within 1 month.
2. Serious complications: including heart failure (≥ New York Heart Association (NYHA) class III), renal insufficiency (creatinine clearance ≤ 30 ml/min), liver dysfunction (serum Alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of normal, or total bilirubin greater than Normal upper limit.
3. Known allergies, hyperreactivity or intolerance of tofacitinib or its excipients.
4. Have a serious infection needing hospitalization (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or use intravenous antibiotics to treat infection in 2 months before the enrollment.
5. Infection with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, it is recommended to consult a doctor who has expertise in treating HIV or hepatitis C virus infection.
6. Any known history of malignancy in the past 5 years (except for nonmelanoma skin cancer, non-melanoma skin cancer or cervical tumor without recurrence within 3 months after surgical cure prior to the first study preparation).
7. Uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past 3 years, may hinder the successful completion of the study.
8. Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Liu Tian
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Liu Tian
associate professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhanguo Li
Role: PRINCIPAL_INVESTIGATOR
Peking University Institute of Rheuamotology and Immunology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Peking2022SLE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.