CompletedPhase 2/3

ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

United States, Argentina68 participantsStarted 2018-02-15

Plain-language summary

VAY736 dose testing; VAY736 efficacy and safety testing.

Age range18 Years – 75 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.

✕. 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 Screening or as long as B-cell count \<50 cells/µL
✕. Required regular use of medications with known hepatotoxicity
✕. Decompensated cirrhosis
✕. Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC).
✕. Drug related AIH at screening or a history of drug related AIH.
✕. History of drug abuse or unhealthy alcohol use
✕. History of malignancy of any organ system
✕. Pregnant or nursing (lactating) women

ALT (Alanine aminotransferase) normalization

Timeframe: Week 24

NCT IDNCT03217422

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-28