ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

  • STATUS
    Recruiting
  • End date
    Jul 4, 2025
  • participants needed
    80
  • sponsor
    Novartis Pharmaceuticals
Updated on 25 July 2021
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (8.8 mi away) Contact
+59 other location
adcc

Summary

VAY736 dose testing; VAY736 efficacy and safety testing.

Description

This is a randomized, placebo-controlled, double-blind dose range study in autoimmune hepatitis. The study population consists of female and male adult autoimmune hepatitis patients with incomplete response or intolerant to standard treatment of care. The diagnosis of autoimmune hepatitis has to fulfill the IAIHG criteria and must be confirmed by liver histology.

Patients will be randomly assigned to different doses of VAY736 or placebo. The primary analysis is planned at 24 weeks. A subsequent study part will then test the efficacy and safety of VAY736 in a parallel group design. For this part of the trial a new group of autoimmune hepatitis patients will be enrolled.

Details
Condition Autoimmune hepatitis
Treatment Placebo, VAY736
Clinical Study IdentifierNCT03217422
SponsorNovartis Pharmaceuticals
Last Modified on25 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

AIH diagnosed per International Autoimmune Hepatitis Group
Liver biopsy with Ishak modified HAI indicating active AIH
Incomplete response to OR intolerance of standard therapy (per AASLD)

Exclusion Criteria

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/L
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
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