CompletedPhase 2

Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments.

France21 participantsStarted 2022-07-27

Plain-language summary

This study aims at elucidating the mechanism of action of ianalumab in salivary glands and explore relationships with clinical assessments

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Written informed consent must be obtained before any assessment is performed
✓. Male and female patients 18 years of age or older at Screening
✓. Confirmed Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria
✓. Seropositive for anti-Ro/SSA antibodies
✓. Screening ESSPRI score ≥ 5
✓. Able to communicate well with the investigator, to understand and comply with the requirements of the study.

✕. Use of other investigational drugs within 5 half-lives of enrollment or within 30 days whichever is longer, or longer if required by local regulations
✕. Presence of another autoimmune rheumatic disease that is active and constitutes the primary illness
✕. Prior use of ianalumab
✕. History of receiving:
✕. Current use of prednisone \>10 mg/day \[or equivalent other corticosteroid\] or dose change within 2 weeks prior to dosing
✕. Prior treatment with any of the following within 6 months of baseline
✕. CTLA4-Fc Ig (abatacept)
✕. Anti-TNF-α mAb

Change in logarithm of salivary gland B/B+T cell ratio

Timeframe: Week 25

NCT IDNCT05124925

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-26