Evaluating Telitacicept for Childhood-onset Systemic Lupus Erythematosus

A Phase 1, Open-label, Multi-center, Multiple-dose Study to Evaluate the Pharmacokinetics of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus

This study is testing a new medication called Telitacicept to see if it is safe and effective for children aged 5-17 with childhood-onset lupus who are already receiving standard treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 5 Years to 17 Years
• Sex: All
• Sponsor: RemeGen Co., Ltd. (Industry-sponsored)
• Drugs / interventions: belimumab, rituximab, cyclophosphamide, prednisone
• Locations: 12 sites (Beijing, Beijing and 11 other locations)
• Trial ID: NCT05687526 on ClinicalTrials.gov

What this trial studies

This multi-center, open-label phase 1 study aims to assess the pharmacokinetics of multiple doses of Telitacicept in children aged 5-17 with childhood-onset systemic lupus erythematosus (cSLE) who are receiving standard care. The study will explore both the safety and efficacy of Telitacicept in this patient population. Participants will be monitored for their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are children aged 5-17 who meet specific classification criteria for systemic lupus erythematosus and have a significant disease activity score.

Not a fit: Patients who have previously received Telitacicept or certain other immunotherapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option for children suffering from cSLE, potentially improving their disease management.

How similar studies have performed: While this approach is novel in the pediatric population, similar studies in adults have shown promising results with Telitacicept.

Eligibility criteria

Main Inclusion Criteria:

1. Fulfills SLICC 2012 or 2019 EULAR/ACR classification criteria for SLE.
2. 5-17 years of age when signing the informed consent.
3. Suject and/or legal guardian or parent provided written informed consent.
4. SELENA SLEDAI score ≥ 8 at screening.
5. Serum autoantibodies (ANA and/or anti ds-DNA) tested positive at screening.
6. Have been on a stable standard of care for SLE for at least 30 days prior to randomization.
7. Female patients are required to be non-pregnant, non-lactating or sterile.

Main Exclusion Criteria:

1. Have received Telitacicept at any time.
2. Have received any of the following therapies within 6 months of baseline: B-cell targeted treatment, e.g., belimumab, rituximab, abatacept, other investigational biologicals.
3. 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.
4. 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.
5. Have received live vaccine within 30 days of baseline.
6. Participated in an interventional clinical trial within 6 months of screening.
7. Active CNS lupus requiring treatment within 60 days of baseline, including seizure, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis or CNS vasculitis.
8. Currently on kidney replacement therapy (hemodialysis, peritoneal dialysis) or in need of such therapy within 90 days of baseline.
9. eGFR\<30 mL/min/1.73m2.
10. Acute severe nephritis.
11. History of vital organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
12. 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.

13 Have planned surgery, laboratory abnormalities, other diseases or conditions that, in the opinion of the investigator, makes the subject unsuitable for the study.

14. 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.

23.History of allergy to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.

24.History of drug or alcohol abuse or dependence within 364 days prior to baseline.

25.Investigators believe that there are other factors that are not suitable for participating in the experiment.

Where this trial is running

Beijing, Beijing and 11 other locations

• Children's Hospital of Capital Institute of Pediatrics — Beijing, Beijing, China (Not_yet_recruiting)
• Peking Union Medical College Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Children's Hospital of Chongqing Medical University — Chongqing, Chongqing, China (Not_yet_recruiting)
• Henan Children's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Hunan Children's Hospital — Changsha, Hunan, China (Recruiting)
• Nanjing Children's Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Xi'an Children's Hospital — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Children's Hospital of Fudan University — Shanghai, Shanghai, China (Not_yet_recruiting)
• Chengdu Women's & Children's Central Hospital — Chengdu, Sichuan, China (Recruiting)
• Children's Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Hongmei Song, M.D. — Peking Union Medical College Hospital
• Study coordinator: Binghua Xiao

Conditions Systemic Lupus Erythematosus; systemic lupus erythematosus; pediatrics; PK