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

Systemic Lupus Erythematosus Clinical Trial

Official title:

Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus: a Randomise Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05339217
• Other study ID #: Peking2022SLE
• Status: Recruiting
• Phase: Phase 3
• Start date: February 7, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: April 2024
• Source: Peking University People's Hospital
• Contact: Tian Liu, Dr
• Phone: +8613661345637
• Email: mikle317[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to explore the clinical and immunological efficacy of Telitacicept and low dose IL-2 on systemic lupus erythematosus.

Description:

Given that Telitacicept and low dose IL2 have been widespreadly applied in the treatment of systemic lupus erythematosus, this study designed a randomised, single center, prospective study to investigate the effects and safety of combined utilization of Telitacicept and low dose IL-2. 160mg Telitacicept and 1 million IU IL2 were regularly administered according to different circumstances. Then, the investigators evaluated the improvement of clinical and laboratory indexes and monitored the changes of immune cell subsets and cytokines.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Department of Rheumatology and Immunology, Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Liu Tian

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of SLE Responder Index (SRI)4 response	The number of participants who achieved SRI4 response at week 24.	Week 24
Secondary	Number of participants with Adverse Events	The number of participants with Adverse Events throughout the study were accessed.	Week 24
Secondary	Autoantibody change from baseline	Blood samples were collected at indicated time-points for analysis of autoantibodies like anti-double stranded deoxyribonucleic Acid(dsDNA). Baseline is defined as the Day 0 visit from parent studies.	Week 12 and 24
Secondary	Change of complement C3 and C4 Levels from baseline	Blood samples were collected at indicated time-points for analysis of complement levels like complement 3 (C3) and complement 4 (C4). Baseline is defined as the Day 0 visit from parent studies.	Week 12 and 24