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 range5 Years – 17 Years

SexALL

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.
✕. 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.
✕. Have received live vaccine within 30 days of baseline.
✕. Participated in an interventional clinical trial within 6 months of screening.
✕. Active CNS lupus requiring treatment within 60 days of baseline, including seizure, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis or CNS vasculitis.
✕. Currently on kidney replacement therapy (hemodialysis, peritoneal dialysis) or in need of such therapy within 90 days of baseline.

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 range5 Years – 17 Years

SexALL

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.
✕. 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.
✕. Have received live vaccine within 30 days of baseline.
✕. Participated in an interventional clinical trial within 6 months of screening.
✕. Active CNS lupus requiring treatment within 60 days of baseline, including seizure, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis or CNS vasculitis.
✕. Currently on kidney replacement therapy (hemodialysis, peritoneal dialysis) or in need of such therapy within 90 days of baseline.

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