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ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

NCT03217422 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-02-19

No results posted yet for this study

Summary

VAY736 dose testing; VAY736 efficacy and safety testing.

Conditions

  • Autoimmune Hepatitis

Interventions

BIOLOGICAL

VAY736

VAY736

OTHER

Placebo

Placebo control with conversion to active VAY736

Sponsors & Collaborators

Principal Investigators

  • Study Director · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-15
Primary Completion
2023-12-28
Completion
2025-12-17
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • Czechia
  • Germany
  • Japan
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03217422 on ClinicalTrials.gov