Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus

Launched by LIU TIAN · Apr 14, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for Systemic Lupus Erythematosus (SLE), a chronic autoimmune disease that affects various parts of the body. The study specifically aims to see how well a combination of two medications, Telitacicept and low-dose IL-2, can improve symptoms and overall health in people with SLE. The trial is currently recruiting participants aged 18 and older who meet certain criteria, such as having a confirmed diagnosis of SLE and stable doses of certain medications for at least four weeks before joining the study.

If you or a loved one decides to participate, you will be closely monitored throughout the trial to track how well the treatment works and if there are any side effects. It's important to know that some individuals may not be eligible to join the trial, particularly those with serious health issues or infections, certain laboratory abnormalities, or a history of certain cancers. Additionally, women who are pregnant or breastfeeding, or who are not using effective contraception, cannot participate. Overall, this trial offers a chance to explore new treatment options for SLE and contribute to research that could help many others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female \>18 years of age at screening visits
• • 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:
• Any subject meeting any of the following criteria should be excluded:
• • 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.