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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05687526
• Other study ID #: 18C018
• Status: Recruiting
• Phase: Phase 1
• Start date: May 25, 2023
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: RemeGen Co., Ltd.
• Contact: Binghua Xiao
• Phone: 86-101-58076833
• Email: binghua.xiao[@]remegen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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.

Locations

Country	Name	City	State
China	Children's Hospital of Capital Institute of Pediatrics	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Hunan Children's Hospital	Changsha	Hunan
China	Chengdu Women's & Children's Central Hospital	Chengdu	Sichuan
China	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Children's Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Nanjing Children's Hospital	Nanjing	Jiangsu
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	The Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Xi'an Children's Hospital	Xi'an	Shaanxi
China	Henan Children's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of Telitacicept	Cmax is defined as peak plasma concentration of Telitacicept	up to 42 days following the last dose of Telitacicept
Primary	tmax of Telitacicept	tmax is defined as time to reach Cmax of Telitacicept	up to 42 days following the last dose of Telitacicept
Primary	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
Primary	Cav of Telitacicept	Average concentration of Telitacicept	up to 42 days following the last dose of Telitacicept
Primary	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
Primary	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
Primary	?z of Telitacicept	?z is defined as terminal elimination rate constant	up to 42 days following the last dose of Telitacicept
Secondary	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
Secondary	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
Secondary	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
Secondary	Change From Baseline in IgG	Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.	Week 4, Week 8, Week 12
Secondary	Change From Baseline in IgA	Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.	Week 4, Week 8, Week 12
Secondary	Change From Baseline in IgM	Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.	Week 4, Week 8, Week 12
Secondary	Change From Baseline in C3	Complement (C3/C4) are proteins that are part of the immune system.	Week 4, Week 8, Week 12
Secondary	Change From Baseline in C4	Complement (C3/C4) are proteins that are part of the immune system.	Week 4, Week 8, Week 12
Secondary	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