NCT03217422

ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of VAY736 in Autoimmune Hepatitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

VAY736 dose testing; VAY736 efficacy and safety testing.

Detailed 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.

Conditions

• Autoimmune Hepatitis

Interventions

Type	Name	Description
BIOLOGICAL	VAY736	VAY736
OTHER	Placebo	Placebo control with conversion to active VAY736

Timeline

• Start date: 2018-02-15
• Primary completion: 2023-12-28
• Completion: 2025-12-17
• First posted: 2017-07-14
• Last updated: 2026-02-19

Locations

28 sites across 10 countries: United States, Argentina, Belgium, Canada, Czechia, Germany, Japan, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study