Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus

NCT05247203 | Completed Phase 1

• 1 other identifier: 18C020
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Keywords

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

Outcome Measures

Primary Outcomes (10)

• Peak plasma concentration (Cmax) of Telitacicept

  Cmax is defined as peak plasma concentration of Telitacicept

  up to 42 days following the last dose of Telitacicept

• Time to reach Cmax (tmax) of Telitacicept

  tmax is defined as time to reach Cmax of Telitacicept

  up to 42 days following the last dose of Telitacicept

• Observed plasma concentration of Telitacicept just prior to the beginning of a dosing interval (Ctrough)

  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

• Average concentration (Cav) of Telitacicept

  Average concentration of Telitacicept

  up to 42 days following the last dose of Telitacicept

• Area under the curve from time zero to last quantifiable concentration (AUC 0-t) of Telitacicept

  AUC 0-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

• Area under the curve from time zero to tau (AUC 0-tau) of Telitacicept

  AUC 0-tau is defined as area under the curve from time zero to tau of Telitacicept

  up to 42 days following the last dose of Telitacicept

• Terminal elimination rate constant (λz) of Telitacicept

  λz is defined as terminal elimination rate constant

  up to 42 days following the last dose of Telitacicept

• Terminal elimination half-life (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

• Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Telitacicept

  Vz/F is defined as apparent volume of distribution during the terminal phase after extravascular administration of Telitacicept

  up to 42 days following the last dose of Telitacicept

• Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Telitacicept

  CL/F is defined as apparent total body clearance of drug from plasma after extravascular administration of Telitacicept

  up to 42 days following the last dose of Telitacicept

Secondary Outcomes (9)

• Percentage of participants achieving a SLE Responder Index (SRI)

  Week 4, 8, 12, 16, 20, and 24

• Percentage of participants achieving a SELENA-SLEDAI improvement of ≥4 points

  Week 4, 8, 12, 16, 20, and 24

• Change From Baseline to W24 in patient global assessment (PGA)

  Week 4, 8, 12, 16, 20, and 24

• Change From Baseline to W24 in IgG

  Week 4, 8, 12, 16, 20, and 24

• Change From Baseline to W24 in IgA

  Week 4, 8, 12, 16, 20, and 24

Study Arms (5)

Telitacicept Arm 1

EXPERIMENTAL

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

Biological: Telitacicept; Drug: standard therapy

Telitacicept Arm 2

EXPERIMENTAL

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

Biological: Telitacicept; Drug: standard therapy

Telitacicept Arm 3

EXPERIMENTAL

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

Biological: Telitacicept; Drug: standard therapy

Telitacicept Arm 4

EXPERIMENTAL

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

Biological: Telitacicept; Drug: standard therapy

Telitacicept Arm 5

EXPERIMENTAL

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

Biological: Telitacicept; Drug: standard therapy

Interventions

Telitacicept BIOLOGICAL

subcutaneous injection

Also known as: RC18

Telitacicept Arm 1; Telitacicept Arm 2; Telitacicept Arm 3; Telitacicept Arm 4; Telitacicept Arm 5

standard therapy 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 1; Telitacicept Arm 2; Telitacicept Arm 3; Telitacicept Arm 4; Telitacicept Arm 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who give consent to this study participation and sign informed consent form;
• Males and females, between the ages of 18 and 65 years old, inclusive, at the screening visit;
• Diagnosis of SLE as defined by the American College of Rheumatology (ACR) 1997 criteria, with 4 or more of the 11 ACR criteria present;
• 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;
• Subjects with unequivocally positive test for anti-nuclear antibody (ANA) and/or anti-ds-DNA serum antibody;
• 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.

You may not qualify if:

• 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;
• 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;
• Laboratory abnormalities including, but not limited to the following:
• ALT/AST≥2×upper limit of normal (ULN);
• endogenous creatinine clearance rate\<30 mL/min;
• white blood cell count\<2.5×10\^9/L;
• hemoglobin\<85 g/L;
• platelet count\<50×10\^9/L;
• 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;
• Subjects with immunodeficiency, uncontrolled severe infection or active/recurrent gastrointestinal ulcers;
• Pregnant or lactating female subjects or sexually active subjects who refuse to practice the protocol-specified contraception throughout the study;
• History of allergy to humanized biological products;
• Subjects who received live vaccine within 28 days of Day 0;
• 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;
• Subjects who received other B-cell targeted drugs, such as Belimumab, rituximab or Epratuzumab within 12 months prior to Day 0;

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (19)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

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

Hefei, Anhui, 230001, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, 541001, China

Location

Affiliated Hospital of Hebei University

Baoding, Hebei, 071000, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264200, China

Location

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

Location

General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300052, China

Location

The People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830001, China

Location

The First People's Hospital of Yunnan Province

Kunming, Yunnan, 650011, China

Location

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases

Interventions

telitacicept; Standard of Care

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

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

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 18, 2022
• Study Start: May 11, 2022
• Primary Completion: October 25, 2023
• Study Completion: November 13, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

CN (19)