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Systemic Lupus ErythematosusPhase 1NCT05687526

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

A Phase 1 study testing Telitacicept in people with Systemic Lupus Erythematosus, run by RemeGen Co., Ltd. at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-center, open-label, phase 1 study. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Telitacicept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
12 sitesChina
Study dates
25 May 2023to 14 Nov 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Main Inclusion Criteria:

  1. Fulfills SLICC 2012 or 2019 EULAR/ACR classification criteria for SLE.
  2. 5-17 years of age when signing the informed consent.
  3. Suject and/or legal guardian or parent 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.
  7. Female patients are required to be non-pregnant, non-lactating or sterile.

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 Have planned surgery, laboratory abnormalities, other diseases or conditions that, in the opinion of the investigator, makes the subject unsuitable for the study.

  1. History of malignant neoplasm in the past 5 years. 15. Primary immune deficiency. 16. Acute or chronic infections requiring treatment. 17. HIV or HCV positive. 18. Tuberculosis. 19.HBsAg/HbcAb positive. 20.HBcAb positive. 21.History of COVID-19 within 4 weeks prior to screening. 22.History of hospitalization due to severe Covid-19 within 12 months prior to screening.

23.History of allergy to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.

24.History of drug or alcohol abuse or dependence within 364 days prior to baseline.

25.Investigators believe that there are other factors that are not suitable for participating in the experiment.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Children's Hospital of Capital Institute of Pediatrics

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • The First Hospital of Jilin University

    Changchun, Jilin

  • Hunan Children's Hospital

    Changsha, Hunan

  • Chengdu Women's & Children's Central Hospital

    Chengdu, Sichuan

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Children's Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Nanjing Children's Hospital

    Nanjing, Jiangsu

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Xi'an Children's Hospital

    Xi'an, Shaanxi

  • Henan Children's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

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

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

Read the 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.

Being tested
Telitacicept
Keywords
systemic lupus erythematosus, pediatrics, PK
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelitaciceptBiological

    Also called RC18

    12-17 years old: Telitacicept 2.5 mg/kg (with a maximum dose of 160 mg) subcutaneously once a week plus SOC for 12 weeks.

    5-11years old: Telitacicept 3.0-3.5 mg/kg (with a maximum dose of 160 mg) subcutaneously once a week plus SOC for 12 weeks.

Study groups in NCT05687526
Study groupRoleWhat they receive
TelitaciceptExperimentalThe dosing of Telitacicept frequency was based on body weight and age.
Receives: Biological: Telitacicept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax of Telitacicept

    Cmax is defined as peak plasma concentration of Telitacicept

    Measured: up to 42 days following the last dose of Telitacicept

  2. tmax of Telitacicept

    tmax is defined as time to reach Cmax of Telitacicept

    Measured: up to 42 days following the last dose of Telitacicept

  3. Ctrough of Telitacicept

    Ctrough is defined as observed plasma concentration of Telitacicept just prior to the beginning of a dosing interval

    Measured: up to 42 days following the last dose of Telitacicept

  4. Cav of Telitacicept

    Average concentration of Telitacicept

    Measured: up to 42 days following the last dose of Telitacicept

  5. AUC0-t of Telitacicept

    AUC0-t is defined as area under the curve from time zero to last quantifiable concentration of Telitacicept

    Measured: up to 42 days following the last dose of Telitacicept

  6. t1/2z of Telitacicept

    t1/2z is defined as terminal elimination half-life of Telitacicept

    Measured: up to 42 days following the last dose of Telitacicept

  7. λz of Telitacicept

    λz is defined as terminal elimination rate constant

    Measured: up to 42 days following the last dose of Telitacicept

Secondary outcomes (9)

  1. 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.

    Measured: Week 4, Week 8, Week 12

  2. 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.

    Measured: Week 4, Week 8, Week 12

  3. 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.

    Measured: Week 4, Week 8, Week 12

  4. Change From Baseline in IgG

    Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.

    Measured: Week 4, Week 8, Week 12

  5. Change From Baseline in IgA

    Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.

    Measured: Week 4, Week 8, Week 12

  6. Change From Baseline in IgM

    Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.

    Measured: Week 4, Week 8, Week 12

  7. Change From Baseline in C3

    Complement (C3/C4) are proteins that are part of the immune system.

    Measured: Week 4, Week 8, Week 12

  8. Change From Baseline in C4

    Complement (C3/C4) are proteins that are part of the immune system.

    Measured: Week 4, Week 8, Week 12

  9. 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.

    Measured: up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2023
  2. Study start25 May 2023
  3. Primary completion14 Nov 2025
  4. Study completion14 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05687526
Sponsor's protocol ID
18C018
Status last verified
Mar 2026
First submitted
8 Jan 2023
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Telitacicept in people with Systemic Lupus Erythematosus, run by RemeGen Co., Ltd. at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of Telitacicept (time frame: up to 42 days following the last dose of Telitacicept). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05687526.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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