A randomized, two-period crossover study to demonstrate the comparability of pharmacokinetics of subcutaneous ianalumab between 2mL auto-injector/2mL pre-filled syringe with 1 mL pre-filled syringe in adult participants with autoimmune disease

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508996-35-00

Acronym

CVAY736A2202

Enrollment

Registered

2024-09-17

Start date

2024-11-18

Completion date

Unknown

Last updated

2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis, Sjögren’s Disease, Systemic Lupus erythematosus

Brief summary

For each cohort, Ianalumab serum concentrations (AUCtau and Cmax) over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24)

Detailed description

For each cohort, ianalumab PK parameters will be determined: Tmax and Ctrough, Adverse events, laboratory evaluations, vital signs, ECG parameters, Anti-ianalumab antibodies (ADA); incidence of ADA positive participants

Interventions

DRUGVAY736

DRUGENTECAVIR

DRUGTENOFOVIR DISOPROXIL

DRUGTENOFOVIR ALAFENAMIDE

DRUG-

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
For each cohort, Ianalumab serum concentrations (AUCtau and Cmax) over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24)	—

Secondary

Measure	Time frame
For each cohort, ianalumab PK parameters will be determined: Tmax and Ctrough, Adverse events, laboratory evaluations, vital signs, ECG parameters, Anti-ianalumab antibodies (ADA); incidence of ADA positive participants	—

Countries

Czechia, Germany, Hungary, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026