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

NCT05339217 | Recruiting Phase 3 DMC

• 1 other identifier: Peking2022SLE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

SLE; Telitacicept; IL-2

Outcome Measures

Primary Outcomes (1)

• Proportion of SLE Responder Index (SRI)4 response

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

  Week 24

Secondary Outcomes (3)

• Number of participants with Adverse Events

  Week 24

• Autoantibody change from baseline

  Week 12 and 24

• Change of complement C3 and C4 Levels from baseline

  Week 12 and 24

Study Arms (3)

Telitacicept and low dose IL2

EXPERIMENTAL

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

Telitacicept

ACTIVE COMPARATOR

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

low dose IL2

ACTIVE COMPARATOR

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

Telitacicept DRUG

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

Telitacicept; Telitacicept and low dose IL2

Interleukin-2 DRUG

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

Telitacicept and low dose IL2; low dose IL2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liu Tian: lead

Study Sites (1)

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

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

telitacicept; RC-18; Interleukin-2

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Zhanguo Li

  Peking University Institute of Rheuamotology and Immunology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tian Liu, Dr

CONTACT

+8613661345637; mikle317@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 21, 2022
• Study Start: February 7, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

CN (1)