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

Sponsor
RemeGen Co., Ltd.
Study ID
NCT05687526
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept — BIOLOGICAL
    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 Details

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

Key Dates

Start date
May 25, 2023
Status verified
Mar 2026
Primary completion
Nov 14, 2025
Completion
Nov 14, 2025

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Telitacicept
    The dosing of Telitacicept frequency was based on body weight and age.

Primary Outcome Measure

Cmax of Telitacicept [ Time Frame: up to 42 days following the last dose of Telitacicept ]

Related Studies