Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06411639
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ianalumab — DRUG
    ianalumab will be provided in a pre-filled Syringe (PFS) of 150 mg/1 mL for s.c. administration. Two injections of 1mL each will be administered monthly.

Study Details

The purpose of this pharmacokinetic (PK) study is to describe the PK profile of ianalumab following s.c. administration in Chinese participants with systemic lupus erythematosus (SLE) and/or Sjögren's disease (SjD). Collection of intensive PK data from Chinese population had been designed in the ianalumab Phase 3 studies of SjD CVAY736A2302 (NCT05349214) and lupus nephritis (LN) CVAY736K12301 (NCT05126277) on an optional basis. This study is conducted to provide supplementary Chinese PK data in addition to the intensive PK data from the two Phase 3 studies .

Key Dates

Start date
Nov 25, 2024
Status verified
Jan 2025
Primary completion
Dec 17, 2025
Completion
Jun 24, 2028

Study Design

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

Arms

  • Experimental: Ianalumab 300 mg
    Participants will receive Ianalumab 300 mg subcutaneous (s.c.) monthly

Primary Outcome Measure

Area Under the Curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) of ianalumab after the 3rd dose [ Time Frame: Week 8 to 12 (Day 57): Pre-dose, Post-dose (24 hours (hr) +/- 12hr, 72 hr +/- 24 hr, 168 hr +/- 72 hr, 336 hr +/- 72hr, 504 hr +/- 72hr) ]

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