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

Primary Purpose

Systemic Lupus Erythematosus

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Telitacicept

Interleukin-2

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE, Telitacicept, IL-2

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female >18 years of age at screening visits
Patients meet the American-European Consensus Group 2002 classification criteria of SLE.
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.
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:

Laboratory abnormality: • Hb≤9 g/dl • Neutrophil 10 mg/d) within 1 month.
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.
Known allergies, hyperreactivity or intolerance of tofacitinib or its excipients.
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.
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.
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).
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.
Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.

Sites / Locations

Department of Rheumatology and Immunology, Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Telitacicept and low dose IL2

Telitacicept

low dose IL2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of SLE Responder Index (SRI)4 response

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

Secondary Outcome Measures

Number of participants with Adverse Events

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

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.

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.

Full Information

NCT ID

NCT05339217

First Posted

April 2, 2022

Last Updated

April 26, 2022

Sponsor

Peking University People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05339217

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2022 (Anticipated)

Primary Completion Date

July 1, 2025 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

Keywords

SLE, Telitacicept, IL-2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telitacicept and low dose IL2

Arm Type

Experimental

Arm Description

Arm Title

Telitacicept

Arm Type

Active Comparator

Arm Description

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

Arm Title

low dose IL2

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Telitacicept

Other Intervention Name(s)

RC-18

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Interleukin-2

Other Intervention Name(s)

Recombinant Human interleukine-2

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proportion of SLE Responder Index (SRI)4 response

Description

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

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Number of participants with Adverse Events

Description

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

Time Frame

Week 24

Title

Autoantibody change from baseline

Description

Time Frame

Week 12 and 24

Title

Change of complement C3 and C4 Levels from baseline

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female >18 years of age at screening visits Patients meet the American-European Consensus Group 2002 classification criteria of SLE. 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. 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: Laboratory abnormality: • Hb≤9 g/dl • Neutrophil 10 mg/d) within 1 month. 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. Known allergies, hyperreactivity or intolerance of tofacitinib or its excipients. 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. 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. 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). 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. Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tian Liu, Dr

Phone

+8613661345637

mikle317@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhanguo Li

Organizational Affiliation

Peking University Institute of Rheuamotology and Immunology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Rheumatology and Immunology, Peking University People's Hospital

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tian Liu

Phone

+8613661345637

mikle317@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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