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NCT07222553

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD

StatusRecruiting
PhasePhase 2
SponsorAmgen
Primary completion (estimated)
Track this trial

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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Eligibility criteria expanded, about 28 words
    • Trial sites expanded: 14 → 19 locations
    • Start date changed from estimate of Oct 31, 2026 to Oct 21, 2026
  2. Start date: Jul 31, 2026 to Oct 31, 2026
    • Trial sites expanded: 0 → 14 locations
    v4
  3. Start date: Apr 3, 2026 to Jul 31, 2026v3
  4. Start date: Feb 27, 2026 to Apr 3, 2026v2
  5. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Maximum Plasma Concentration (Cmax) of Inebilizumab
Timeframe: Up to Day 561
Area Under the Plasma Concentration-time Curve (AUC) of Inebilizumab
Timeframe: Up to Day 561
Clearance (CL) of Inebilizumab
Timeframe: Up to Day 561
Terminal Half-life (t½) of Inebilizumab
Timeframe: Up to Day 561
Volume of Distribution at Steady-state (Vss) of Inebilizumab
Timeframe: Up to Day 561
Change from Baseline in CD20+ B-cell Counts
Timeframe: Baseline and Day 561
Number of Participants Experiencing Adverse Events (AEs)
Timeframe: Up to Day 561
Number of Participants Experiencing Serious Adverse Events (SAEs)
Timeframe: Baseline up to Day 561
Number of Participants Experiencing Events of Interest (EOIs)
Timeframe: Baseline up to Day 561
Number of Participants Experiencing Clinically Significant Changes from Baseline in Laboratory Parameters
Timeframe: Baseline up to Day 561
Number of Participants Experiencing Clinically Significant Changes from Baseline in Vital Signs
Timeframe: Baseline up to Day 561

Secondary (5)

Time-to-first Treated Flare Across 52 Weeks
Percentage of Flare-free Participants Across 52 Weeks
Annualized Flare Rate Across 52 Weeks
Presence of Antidrug Antibodies (ADA) Before and After Initiation of Treatment
Percent Reduction from Baseline in Daily Glucocorticoid Dose at Week 52

Arms and interventions

InebilizumabExperimental

Participants will receive Inebilizumab via intravenous (IV) infusion.

Drugs: Inebilizumab

Sites

19 sites in 8 countries

Brazil 3, China 3, Poland 3, Turkey (Türkiye) 3, United States 3, Greece 2, Italy 1, Spain 1