A Study of Telitacicept in Subjects With 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 is a multi-center, open-label, phase 1 study.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Biological: Telitacicept 2.5 mg/kg

Detailed Description

The purpose of this study is to evaluate the pharmacokinetics (PK) of multiple doses of Telitacicept in subjects with childhood-onset systemic lupus erythematosus (cSLE) on a background of standard of care therapy and explore the safety and efficacy of Telitacicept in patients with cSLE.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Binghua Xiao; Phone Number: 86-101-58076833; Email: binghua.xiao@remegen.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Not yet recruiting
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China
      • Not yet recruiting
      • Children's Hospital of Capital Institute of Pediatrics
  • Chongqing
    • Chongqing, Chongqing, China
      • Not yet recruiting
      • Children's Hospital of Chongqing Medical University
  • Henan
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan Children's Hospital
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Children's Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Not yet recruiting
      • Nanjing Children's Hospital
  • Jilin
    • Changchun, Jilin, China
      • Not yet recruiting
      • The First Hospital of Jilin University
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Not yet recruiting
      • Xi'an Children's Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Children's Hospital of Fudan University
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Chengdu Women's & Children's Central Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Children's Hospital of Zhejiang University School of Medicine
    • Wenzhou, Zhejiang, China
      • Recruiting
      • The Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria:

1. Fulfills SLICC 2012 or 2019 EULAR/ACR classification criteria for SLE.
2. 12-17 years of age when signing the informed consent.
3. Parent or legal guardian 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.

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. History of malignant neoplasm in the past 5 years.
14. Primary immune deficiency.
15. Acute or chronic infections requiring treatment.
16. HIV/HCV/HBsAg/HBcAb positive.
17. Tuberculosis.
18. Have planned surgery, laboratory abnormalities, other diseases or conditions that, in the opinion of the investigator, makes the subject unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telitacicept 2.5 mg/kg	Biological: Telitacicept 2.5 mg/kg; Subjects will be given Telitacicept 2.5 mg/kg (with a maximum dose of 160 mg) subcutaneously once a week plus SOC for 12 weeks.; Other Names: RC18

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SLE Responder Index 4 (SRI 4)	SRI 4 is defined as a. SELENA-SLEDAI score reduced from baseline by at least 4 points; b. no new BILAG A or no more than 1 BILAG B compared to baseline; c. physician's global assessment (PGA) increased from baseline by less than 0.3 points.	Week 4, Week 8, Week 12
Proportion of subjects with SELENA-SLEDAI score reduced from baseline by at least 4 points.	The SELENA-SLEDAI is a tool for measuring the activity of systemic lupus. The total score ranges from 0-105, with a higher score representing a more significant degree of disease activity.	Week 4, Week 8, Week 12
Change from baseline in PGA.	The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.	Week 4, Week 8, Week 12
Change From Baseline in IgG	Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.	Week 4, Week 8, Week 12
Change From Baseline in IgA	Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.	Week 4, Week 8, Week 12
Change From Baseline in IgM	Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.	Week 4, Week 8, Week 12
Change From Baseline in C3	Complement (C3/C4) are proteins that are part of the immune system.	Week 4, Week 8, Week 12
Change From Baseline in C4	Complement (C3/C4) are proteins that are part of the immune system.	Week 4, Week 8, Week 12
Incidence of AEs	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	up to Week 12

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.
• Investigators: Principal Investigator: Hongmei Song, M.D., Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 8, 2023
• First Submitted That Met QC Criteria: January 8, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: pediatrics; PK; systemic lupus erythematosus
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 18C018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No