A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus
Condition(s) studied
Investigational drug(s) / intervention(s)
Anifrolumab + APFS: Anifrolumab will be administered as a SC injection using an APFS.
Study summary
The purpose of this study is to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while on background standard of care (SoC) therapy.
Eligibility
Primary outcome measure(s)
- Maximum observed serum (peak) concentration (Cmax) — Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
To characterize PK (Cmax) of anifrolumab in pediatric participants with SLE following SC administration. - Area under the serum concentration-time curve (AUC) — Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
To characterize PK (AUC) of anifrolumab in pediatric participants with SLE following SC administration. - Time to maximum plasma concentration (tmax) — Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
To characterize PK (tmax) of anifrolumab in pediatric participants with SLE following SC administration. - Apparent total body clearance of drug from plasma (CL/F) — Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
To characterize PK (CL/F) of anifrolumab in pediatric participants with SLE following SC administration. - Trough drug concentration at steady state (Ctrough,ss) — At Week 12
To characterize PK (Ctrough,ss) of anifrolumab in pediatric participants with SLE following SC administration.
Trial sites (32)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Parkville | Australia | Not Yet Recruiting |
| Research Site | Westmead | Australia | Not Yet Recruiting |
| Research Site | Brussels | Belgium | Not Yet Recruiting |
| Research Site | Ghent | Belgium | Not Yet Recruiting |
| Research Site | Leuven | Belgium | Not Yet Recruiting |
| Research Site | Liège | Belgium | Not Yet Recruiting |
| Research Site | Santiago | Chile | Not Yet Recruiting |
| Research Site | Haifa | Israel | Not Yet Recruiting |
| Research Site | Kfar Saba | Israel | Not Yet Recruiting |
| Research Site | Petah Tikva | Israel | Not Yet Recruiting |
| Research Site | Ramat Gan | Israel | Not Yet Recruiting |
| Research Site | Ginowan-shi | Japan | Not Yet Recruiting |
| Research Site | Kagoshima | Japan | Not Yet Recruiting |
| Research Site | Kanazawa | Japan | Not Yet Recruiting |
| Research Site | Niigata | Japan | Not Yet Recruiting |
| Research Site | Amsterdam | Netherlands | Not Yet Recruiting |
| Research Site | Rotterdam | Netherlands | Not Yet Recruiting |
| Research Site | Utrecht | Netherlands | Not Yet Recruiting |
| Research Site | Lima | Peru | Not Yet Recruiting |
| Research Site | Lima | Peru | Not Yet Recruiting |
| Research Site | Lima | Peru | Not Yet Recruiting |
| Research Site | Lima | Peru | Not Yet Recruiting |
| Research Site | Cebu City | Philippines | Not Yet Recruiting |
| Research Site | Dagupan | Philippines | Not Yet Recruiting |
| Research Site | Manila | Philippines | Not Yet Recruiting |
| Research Site | Manila | Philippines | Not Yet Recruiting |
| Research Site | Lisbon | Portugal | Not Yet Recruiting |
| Research Site | Lisbon | Portugal | Not Yet Recruiting |
| Research Site | Porto | Portugal | Not Yet Recruiting |
| Research Site | Porto | Portugal | Not Yet Recruiting |
| Research Site | Belgrade | Serbia | Recruiting |
| Research Site | Niš | Serbia | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07630714 on ClinicalTrials.gov ↗ ← All trials in Japan