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RecruitingNCT05339217Updated Apr 3, 2024

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

A Phase 3 interventional study of Telitacicept and Interleukin-2 in Systemic Lupus Erythematosus, sponsored by Liu Tian. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-03.

Sponsored by Liu Tian · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 8 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • SLE
  • Telitacicept
  • IL-2
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Liu Tian is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: Telitacicept · Drug: Interleukin-2

  • Active comparator
    Telitacicept

    160mg Telitacicept was subcutaneously injected to patients with systemic lupus erythematosus at the outer side of upper arm every week for 24 weeks.

    Drug: Telitacicept

  • Active comparator
    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.

    Drug: Interleukin-2

Interventions

  • DrugTelitacicept

    160mg Telitacicept was subcutaneously injected to patients with systemic lupus erythematosus at the outer side of upper arm every week for 24 weeks.

    Also known as: RC-18

  • DrugInterleukin-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.

    Also known as: Recombinant Human interleukine-2

06

What researchers measure

Primary outcomes

  1. Proportion of SLE Responder Index (SRI)4 response

    The number of participants who achieved SRI4 response at week 24.

    Time frame: Week 24

Secondary outcomes

  1. Number of participants with Adverse Events

    The number of participants with Adverse Events throughout the study were accessed.

    Time frame: Week 24

  2. 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.

    Time frame: Week 12 and 24

  3. 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.

    Time frame: Week 12 and 24

07

Study locations

1 of 1 sites recruiting
  • Department of Rheumatology and Immunology, Peking University People's Hospital
    Beijing, Beijing, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05339217
Lead sponsor
Liu Tian
Responsible party
Liu Tian (associate professor, Peking University People's Hospital) — Sponsor-investigator
First posted
Apr 21, 2022
Start date
Feb 7, 2023
Primary completion
Jul 1, 2025 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Apr 3, 2024

Study contacts

Tian Liu, Dr
Contact
mikle317@163.com
+8613661345637
Zhanguo Li
principal investigator · Peking University Institute of Rheuamotology and Immunology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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