A Study of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus

NCT05687526 | Completed Phase 1

• 1 other identifier: 18C018
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 12

Brief Summary

This is a multi-center, open-label, phase 1 study.

Conditions

Systemic Lupus Erythematosus

Keywords

systemic lupus erythematosus; pediatrics; PK

Outcome Measures

Primary Outcomes (7)

• Cmax of Telitacicept

  Cmax is defined as peak plasma concentration of Telitacicept

  up to 42 days following the last dose of Telitacicept

• tmax of Telitacicept

  tmax is defined as time to reach Cmax of Telitacicept

  up to 42 days following the last dose of Telitacicept

• Ctrough of Telitacicept

  Ctrough is defined as observed plasma concentration of Telitacicept just prior to the beginning of a dosing interval

  up to 42 days following the last dose of Telitacicept

• Cav of Telitacicept

  Average concentration of Telitacicept

  up to 42 days following the last dose of Telitacicept

• AUC0-t of Telitacicept

  AUC0-t is defined as area under the curve from time zero to last quantifiable concentration of Telitacicept

  up to 42 days following the last dose of Telitacicept

• t1/2z of Telitacicept

  t1/2z is defined as terminal elimination half-life of Telitacicept

  up to 42 days following the last dose of Telitacicept

• λz of Telitacicept

  λz is defined as terminal elimination rate constant

  up to 42 days following the last dose of Telitacicept

Secondary Outcomes (9)

• SLE Responder Index 4 (SRI 4)

  Week 4, Week 8, Week 12

• Proportion of subjects with SELENA-SLEDAI score reduced from baseline by at least 4 points.

  Week 4, Week 8, Week 12

• Change from baseline in PGA.

  Week 4, Week 8, Week 12

• Change From Baseline in IgG

  Week 4, Week 8, Week 12

• Change From Baseline in IgA

  Week 4, Week 8, Week 12

Study Arms (1)

Telitacicept

EXPERIMENTAL

The dosing of Telitacicept frequency was based on body weight and age.

Biological: Telitacicept

Interventions

Telitacicept BIOLOGICAL

12-17 years old: Telitacicept 2.5 mg/kg (with a maximum dose of 160 mg) subcutaneously once a week plus SOC for 12 weeks. 5-11years old: Telitacicept 3.0-3.5 mg/kg (with a maximum dose of 160 mg) subcutaneously once a week plus SOC for 12 weeks.

Also known as: RC18

Telitacicept

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Fulfills SLICC 2012 or 2019 EULAR/ACR classification criteria for SLE.
• years of age when signing the informed consent.
• Suject and/or legal guardian or parent provided written informed consent.
• SELENA SLEDAI score ≥ 8 at screening.
• Serum autoantibodies (ANA and/or anti ds-DNA) tested positive at screening.
• Have been on a stable standard of care for SLE for at least 30 days prior to randomization.
• Female patients are required to be non-pregnant, non-lactating or sterile.

You may not qualify if:

• Have received Telitacicept at any time.
• Have received any of the following therapies within 6 months of baseline: B-cell targeted treatment, e.g., belimumab, rituximab, abatacept, other investigational biologicals.
• Have received any of the following therapies within 90 days of baseline: anti-TNF or anti-IL-6 therapy, interleukin-1 receptor antagonist, intravenous immunoglobulin (IVIG), plasmapheresis.
• Have received any of the following therapies within 30 days of baseline: Intravenous cyclophosphamide, non-biological investigational agents (within 30 days of baseline or 5 half-lives, whichever is longer), newly added immunosuppressive/immunomodulatory agent, anti-malarial, NSAID, high-dose prednisone or equivalent (\> 1.5 mg/kg/day) or any intramuscular or intravenous steroid.
• Have received live vaccine within 30 days of baseline.
• Participated in an interventional clinical trial within 6 months of screening.
• Active CNS lupus requiring treatment within 60 days of baseline, including seizure, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis or CNS vasculitis.
• Currently on kidney replacement therapy (hemodialysis, peritoneal dialysis) or in need of such therapy within 90 days of baseline.
• eGFR\<30 mL/min/1.73m2.
• Acute severe nephritis.
• History of vital organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
• Significant unstable or uncontrolled acute or chronic diseases (cardiovascular, lung, hematology, gastrointestinal, liver, renal, neurologic, malignancy or infectious disease) that could be explained by causes other than SLE.
• Have planned surgery, laboratory abnormalities, other diseases or conditions that, in the opinion of the investigator, makes the subject unsuitable for the study.
• \. History of malignant neoplasm in the past 5 years. 15. Primary immune deficiency. 16. Acute or chronic infections requiring treatment. 17. HIV or HCV positive. 18. Tuberculosis. 19.HBsAg/HbcAb positive. 20.HBcAb positive. 21.History of COVID-19 within 4 weeks prior to screening. 22.History of hospitalization due to severe Covid-19 within 12 months prior to screening.
• History of allergy to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (12)

Children's Hospital of Capital Institute of Pediatrics

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Henan Children's Hospital

Zhengzhou, Henan, China

Location

Hunan Children's Hospital

Changsha, Hunan, China

Location

Nanjing Children's Hospital

Nanjing, Jiangsu, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Xi'an Children's Hospital

Xi'an, Shaanxi, China

Location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

Chengdu Women's & Children's Central Hospital

Chengdu, Sichuan, China

Location

Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

telitacicept

Condition Hierarchy (Ancestors)

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

Study Officials

• Hongmei Song, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 18, 2023
• Study Start: May 25, 2023
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

CN (12)