An open-label, non-randomized, biopsy-based mechanistic study on efficacy, pharmacokinetics, pharmacodynamics, safety and tolerability of ianalumab in patients with Sjögren's syndrome - Biopsy-based mechanistic study

ovartis Pharma AG0 sites24 target enrollmentNovember 10, 2021

Overview

No summary available.

Registry

who.int

Start Date

November 10, 2021

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Classification of Sjögren's syndrome according to the 2016 ACR/EULAR criteria at screening.
•Historical labial minor salivary gland biopsy showing a focus score \=1 Seropositive at screening for anti\-Ro/SSA antibodies
•Screening EULAR Sjögren’s syndrome patient reported index (ESSPRI) score \= 5
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 24
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•\- Presence of another autoimmune rheumatic disease that is active and constitutes the principle illness, specifically:
•\- Moderate\-to\-severe active systemic lupus erythematosus (SLE) with anti\-dsDNA positivity and renal involvement, or other organ involvement that impedes on ability to score ESSPRI or ESSDAI
•\- Active rheumatoid arthritis (RA) that impedes on the ability to
•score ESSPRI or ESSDAI
•Systemic sclerosis
•\- Any other concurrent connective tissue disease (e.g., large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's syndrome assessment ESSPRI or ESSDAI.
•Prior use of ianalumab
•\- Prior use of any B cell depleting therapy (e.g., rituximab or other anti\-CD20 mAb, anti\-CD22 mAb or anti\-CD52 mAb within 1 year prior to dosing
•\- B cell count \<50 cells/µL
•\- Current use of prednisone \>10 mg/day \[or equivalent other corticosteroid] or dose change within 2 weeks prior to dosing