A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus

Sponsor
AstraZeneca
Study ID
NCT07630714
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Anifrolumab + APFS — COMBINATION_PRODUCT
    Anifrolumab will be administered as a SC injection using an APFS.

Study Details

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.

Key Dates

First listed
Jun 5, 2026
Start date
Jul 28, 2026
Status verified
May 2026
Primary completion
Sep 3, 2030
Completion
Sep 5, 2031

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (body weight > 40 kg)
    Participants with body weight \> 40 kg will receive anifrolumab as an injection in APFS.
  • Experimental: Cohort 2 (body weight ≥ 15 to ≤ 40 kg)
    Participants with body weight ≥ 15 to ≤ 40 kg will receive anifrolumab as an injection in APFS.

Primary Outcome Measure

Maximum observed serum (peak) concentration (Cmax) [ Time Frame: Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11 ]

Central Contacts

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