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Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients

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ClinicalTrials.gov Identifier: NCT05666336
Recruitment Status : Recruiting
First Posted : December 27, 2022
Last Update Posted : January 17, 2024
Sponsor:
Information provided by (Responsible Party):
Fen Li, Central South University

Study Description
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Brief Summary:
Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with abnormal activation of B lymphocytes, which may result in many adverse consequences and even death if not treated actively. Telitacicept, approved conditionally in China in March 2021, is a biologic agent targeting B lymphocyte stimulator (BLyS）and a proliferating inducing ligand (APRIL) dually for patients with active SLE patients who have not responded to conventional treatment. The investigators hope to screen predictive biomarkers of efficacy and explore the mechanism of difference in efficacy of Telitacicept with Chinese characteristics by omics.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: Telitacicept Drug: Hydroxychloroquine Drug: Prednisone Drug: Methylprednisolone Drug: Cyclophosphamide Drug: Mycophenolate Mofetil Drug: Tacrolimus Phase 4

Detailed Description:
Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with abnormal activation of B lymphocytes, which may result in many adverse consequences and even death if not treated actively. Due to the poor therapeutic efficacy and prominent adverse reactions after long-term use of glucocorticoid combined immunosuppressants, the development of targeted drug use for SLE has become a hot area of research for several years. Telitacicept, approved conditionally in China in March 2021, is a biologic agent targeting B lymphocyte stimulator (BLyS）and a proliferating inducing ligand (APRIL) dually for patients with active SLE patients who have not responded to conventional treatment. As another important part of targeted drug use, the research on biomarkers predictive of drug response is also in full swing in the treatment of SLE. The omics technology has unique advantages in screening biomarkers and exploring the mechanism of drug action. The integrated analysis of multi omics can mutually verify and supplement the screening results of a single omics, so as to more systematically and comprehensively analyze the biological molecular functions and regulatory mechanisms. Therefore, this topic selects serum proteomics combined with metabolomics to screen biomarkers for the prediction of the efficacy of Telitacicept, and to explore the mechanism of the difference in the efficacy of Telitacicept, with a view to providing meaningful reference for the exploration of SLE precise treatment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus Erythematosus
Actual Study Start Date : December 31, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Group

The treatment regimen consists of four drugs, a glucocorticoid plus Telitacicept plus hydroxychloroquine plus an immunosuppressor.

Prednisone(30mg, Qd) or Methylprednisolone(24mg, Qd) plus Telitacicept(160mg, Qw) plus Hydroxychloroquine (0.2g, Qd) plus cyclophosphamide(0.8g, Qm) or Mycophenolate Mofetil (0.5g, Bid) or Tacrolimus (1mg, Bid) The above treatment will continue for 24 weeks.

 Biological: Telitacicept
It is necessary and will be given by subcutaneous injection of 160mg/week for 24 weeks.
Other Name: RC18

Drug: Hydroxychloroquine
It is necessary and will be given by oral administration of 0.2g/day for 24 weeks.
Other Name: HCQ

Drug: Prednisone
It is permitted which can be interchangeable with methylprednisolone. It will be given by oral administration of 30mg/day from beginning and be lowed dosage during the treatment of 24 weeks.
Other Name: PRED

Drug: Methylprednisolone
It is permitted which can be interchangeable with prednisone. It will be given by oral administration of 24mg/day from beginning and be lowed dosage during the treatment of 24 weeks.
Other Name: MP

Drug: Cyclophosphamide
It is permitted which can be interchangeable with mycophenolate mofetil or tacrolimus. It will be given by oral administration of 0.8g/month for 24 weeks.
Other Name: CTX

Drug: Mycophenolate Mofetil
It is permitted which can be interchangeable with cyclophosphamide or tacrolimus. It will be given by oral administration of 0.5g twice a day for 24 weeks.
Other Name: MMF

Drug: Tacrolimus
It is permitted which can be interchangeable with cyclophosphamide or mycophenolate mofetil. It will be given by oral administration of 1mg twice a day for 24 weeks.
Other Name: TAC


Outcome Measures
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Primary Outcome Measures :
  1. SLE Responder Index (SRI) 4 response rate [ Time Frame: week 24 ]
    (1) Definition of SRI4: ≥4 point reduction from baseline in SELENA-SLEDAI score, no worsening (<0.3 point increase from baseline) in Physician's Global Assessment (PGA) and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or two new BILAG B organ domain scores vs baseline. (2) The patients acquired SRI4 were classified as Good Responders (GR), The patients not acquired SRI4 were classified as Non-Responders (NR).


Secondary Outcome Measures :
  1. The changes of glucocorticoids dose [ Time Frame: week 24 ]
    The percentage of patients whose average prednisone dose was ≤7.5 mg/day or reduced by ≥25% from baseline.

  2. The variation of serum markers [ Time Frame: week 24 ]
    The variation of serum markers including BLyS,APRIL,CD19+B lymphocytes count, anti-dsDNA antibodies, IgG, IgA, IgM, complement3(C3), and complement4(C4) at baseline and after 24 weeks' treatment.

  3. Proteomics [ Time Frame: week 24 ]
    Screening and comparison of different proteins

  4. Metabonomics [ Time Frame: week 24 ]
    Screening and comparison of different metabolites


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with a clinical diagnosis of SLE according to American College of Rheumatology (ACR) classification criteria 1997 and clinically active disease.
  2. Patients with good compliance, will sign the informed consent before the test.
  3. Patients who have received conventional treatment for SLE, and the type and dose of treatment drugs have been stable for at least 30 days.
  4. Patients who have a positive anti-nuclear antibody test result and SELENA-SLEDAI score ≥8 at screening. If there is a low complement and/or positive anti-dsDNA antibody, the SELENA-SLEDAI score can be defined as ≥ 6 points.

Exclusion Criteria:

  1. Patients with severe lupus nephritis, defined as urinary protein > 6g /24 hours or serum creatinine > 221μmol/L within the last 2 months, or who require hemodialysis.
  2. Patients with SLE-caused or non-SLE-caused central nervous system disease within the last 2 months.
  3. Patients with severe condition in blood, important organs including heart, liver, gastrointestinal tract and endocrine system which are not related with SLE.
  4. Patients who use prednisone ≥100mg/d over 14 days or receive plasma replacement and suffer from active infection within the last 1 month.
  5. Patients who received any other targeted agents over the past 12 months.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05666336


Contacts
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Contact: Fen Li, doctor 0086-731-85295255 lifen0731@csu.edu.cn
Contact: Hui yu Nie, bachelor 0086-18113519492 niehuiyu2022@163.com

Locations
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China, Hunan
Department of Rheumatology and Immunology, Xiangya Second Hospital, Central South University Recruiting
Changsha, Hunan, China, 410000
Contact: Huiyu Nie    18113519492    niehuiyu2022@163.com   
Sponsors and Collaborators
Fen Li
Investigators
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Principal Investigator: Fen Li, doctor Central South University
More Information
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Publications:

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Responsible Party: Fen Li, chief physician, Central South University
ClinicalTrials.gov Identifier: NCT05666336    
Other Study ID Numbers: LYF2022151
First Posted: December 27, 2022    Key Record Dates
Last Update Posted: January 17, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fen Li, Central South University:
Systemic Lupus Erythematosus
Telitacicept
efficiency
omics
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Hydroxychloroquine
Prednisone
Methylprednisolone
Cyclophosphamide
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
 Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Calcineurin Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents