CompletedPhase 1

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

China16 participantsStarted 2023-05-25

Plain-language summary

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

Who can participate

Age range

5 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Fulfills SLICC 2012 or 2019 EULAR/ACR classification criteria for SLE.
. 5-17 years of age when signing the informed consent.
. Suject and/or legal guardian or parent provided written informed consent.
. SELENA SLEDAI score ≥ 8 at screening.
. Serum autoantibodies (ANA and/or anti ds-DNA) tested positive at screening.
. Have been on a stable standard of care for SLE for at least 30 days prior to randomization.
. Female patients are required to be non-pregnant, non-lactating or sterile.

Exclusion criteria

. Have received Telitacicept at any time.
. Have received any of the following therapies within 6 months of baseline: B-cell targeted treatment, e.g., belimumab, rituximab, abatacept, other investigational biologicals.
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cmax of Telitacicept

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

tmax of Telitacicept

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

Ctrough of Telitacicept

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

Cav of Telitacicept

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

AUC0-t of Telitacicept

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

t1/2z of Telitacicept

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

λz of Telitacicept

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

Trial details

NCT IDNCT05687526

SponsorRemeGen Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-14

View on ClinicalTrials.gov More Systemic Lupus Erythematosus trials

Who can participate

Age range

5 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Fulfills SLICC 2012 or 2019 EULAR/ACR classification criteria for SLE.
. 5-17 years of age when signing the informed consent.
. Suject and/or legal guardian or parent provided written informed consent.
. SELENA SLEDAI score ≥ 8 at screening.
. Serum autoantibodies (ANA and/or anti ds-DNA) tested positive at screening.
. Have been on a stable standard of care for SLE for at least 30 days prior to randomization.
. Female patients are required to be non-pregnant, non-lactating or sterile.

Exclusion criteria

. Have received Telitacicept at any time.
. Have received any of the following therapies within 6 months of baseline: B-cell targeted treatment, e.g., belimumab, rituximab, abatacept, other investigational biologicals.
. 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.

What they're measuring

Cmax of Telitacicept

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

tmax of Telitacicept

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

Ctrough of Telitacicept

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

Cav of Telitacicept

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

AUC0-t of Telitacicept

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

t1/2z of Telitacicept

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

λz of Telitacicept

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