Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus

NCT ID: NCT05247203

Last Updated: 2023-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2023-11-13

Brief Summary

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

Detailed Description

The purpose of this study is to evaluate the pharmacokinetics, safety and efficacy of Telitacicept in Chinese patients with systemic lupus erythematosus.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; Telitacicept; Pharmacokinetics; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telitacicept Arm 1

Telitacicept 80mg, once a week for 24 weeks plus standard therapy

Group Type: EXPERIMENTAL

Telitacicept

Intervention Type: BIOLOGICAL

subcutaneous injection

standard therapy

Intervention Type: DRUG

A standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine.

Telitacicept Arm 2

Telitacicept 160mg, once a week for 24 weeks plus standard therapy

Group Type: EXPERIMENTAL

Telitacicept

Intervention Type: BIOLOGICAL

subcutaneous injection

standard therapy

Intervention Type: DRUG

A standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine.

Telitacicept Arm 3

Telitacicept 160mg, once a week for 12 weeks followed by once every two weeks for another 12 weeks plus standard therapy

Group Type: EXPERIMENTAL

Telitacicept

Intervention Type: BIOLOGICAL

subcutaneous injection

standard therapy

Intervention Type: DRUG

A standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine.

Telitacicept Arm 4

Telitacicept 240mg, once a week for 24 weeks plus standard therapy

Group Type: EXPERIMENTAL

Telitacicept

Intervention Type: BIOLOGICAL

subcutaneous injection

standard therapy

Intervention Type: DRUG

A standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine.

Telitacicept Arm 5

Telitacicept 240mg, once every two weeks for 24 weeks plus standard therapy

Group Type: EXPERIMENTAL

Telitacicept

Intervention Type: BIOLOGICAL

subcutaneous injection

standard therapy

Intervention Type: DRUG

A standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine.

Interventions

Telitacicept

subcutaneous injection

Intervention Type: BIOLOGICAL

standard therapy

A standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine.

Intervention Type: DRUG

Other Intervention Names

RC18

Eligibility Criteria

Inclusion Criteria

1. Subjects who give consent to this study participation and sign informed consent form;

2. Males and females, between the ages of 18 and 65 years old, inclusive, at the screening visit;

3. Diagnosis of SLE as defined by the American College of Rheumatology (ACR) 1997 criteria, with 4 or more of the 11 ACR criteria present;

4. SELENA-SLEDAI score ≥8 points with a clinical SELENA-SLEDAI score ≥6 points if low complement levels and/or anti-ds-DNA antibodies are present at the screening visit;

5. Subjects with unequivocally positive test for anti-nuclear antibody (ANA) and/or anti-ds-DNA serum antibody;

6. Be on a SLE standard treatment regimen (and remain stable) for a period of at least 30 days prior to Day 0. The standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine.

Exclusion Criteria

1. Subjects with severe lupus kidney disease (defined by proteinuria >6g/24h or serum creatinine >2.5mg/dL or serum creatinine >221μmol/L) or active nephritis requiring prohibited medications, or subjects requiring hemodialysis or prednisone (or its equivalent)≥100mg/d for a period of ≥14 days within 8 weeks of Day 0;

2. Central nervous system (CNS) disease associated with lupus or not [including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), encephalitis, CNS angiitis] within 8 weeks prior to the screening visit;

3. Laboratory abnormalities including, but not limited to the following:

1. ALT/AST≥2×upper limit of normal (ULN);

2. endogenous creatinine clearance rate<30 mL/min;

3. white blood cell count<2.5×10^9/L;

4. hemoglobin<85 g/L;

5. platelet count<50×10^9/L;

4. Active hepatitis or a history of severe liver disease at the screening visit. Positive test for Hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibodies (HCVAb). If anti-HBcAb result is positive while HBsAg result is negative, hepatitis B virus (HBV)-(DNA) test will be performed. If HBV-DNA result is negative, the patient is eligible;

5. Subjects with immunodeficiency, uncontrolled severe infection or active/recurrent gastrointestinal ulcers;

6. Pregnant or lactating female subjects or sexually active subjects who refuse to practice the protocol-specified contraception throughout the study;

7. History of allergy to humanized biological products;

8. Subjects who received live vaccine within 28 days of Day 0;

9. Participation in any other investigational study drug trial in the past 28 days or 5 half-lives, whichever was longer, prior to Day 0. Subjects who participated in a clinical trial on B-cell-targeted drug, or tumor necrosis factor inhibitor, or interleukin receptor blocker within 12 months prior to Day 0 would be excluded;

10. Subjects who received other B-cell targeted drugs, such as Belimumab, rituximab or Epratuzumab within 12 months prior to Day 0;

11. Subjects who received tumor necrosis factor inhibitors, interleukin receptor blockers within 12 months prior to Day 0;

12. Subjects who received intravenous immune globulin (IVIG), or high dose prednisone or its equivalents (≥100mg/d) for a period of ≥ 14 days, or plasma exchange within 28 days prior to Day 0;

13. Subjects who received IL-2, Thalidomide, Tripterygium wilfordii or Chinese medicinal preparations containing Tripterygium wilfordii within 28 days prior to Day 0;

14. Subjects with active infections (herpes zoster, HIV infection, active tuberculosis, etc.) at the screening visit;

15. Subjects with depression or suicidal thoughts;

16. Any condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol..

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RemeGen Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Affiliated Hospital of Hebei University

Baoding, Hebei, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Xiangya Hospital, Central South University

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

The People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

18C020

Identifier Type: -

Identifier Source: org_study_id