ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

Learn more about:
Related Clinical Trial
Tacrolimus Versus Mycophenolate for Autoimmune Hepatitis Patients With Incomplete Response on First Line Therapy Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH) A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule ADCC Mediated B-Cell dEpletion and BAFF-R Blockade Liver Test Study of Using JKB-122 in AIH Patients Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease Umbilical Cord Mesenchymal Stem Cells for Patients With Autoimmune Hepatitis Mycophenolate vs Azathioprin in Autoimmune Hepatitis Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis A Phase 2a Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune Hepatitis Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis Biomarkers to Predict the Success of Immunosuppression Withdrawal in Autoimmune Hepatitis Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS Mindfulness – Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis Possible Role of Chloroquine to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial The Role of Sodium Chloride and the Treg/Th17 Axis in Autoimmune Hepatitis Quantitative Magnetic Resonance Imaging to Aid Clinical Decision Making in Autoimmune Hepatitis. Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH) De Novo Autoimmune Hepatitis in Pediatric Liver Transplantation Autoimmune Hepatitis in Pediatric Patients

Brief Title

ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

Official Title

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

Brief 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

      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.

Study Phase

Phase 2/Phase 3

Study Type


Primary Outcome

ALT (Alanine aminotransferase) normalization

Secondary Outcome

 ALT normalization by dose


Autoimmune Hepatitis



Study Arms / Comparison Groups

 Arm 1
Description:  VAY736 Dose 1


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

February 15, 2018

Completion Date

July 4, 2025

Primary Completion Date

July 4, 2025

Eligibility Criteria

        Key Inclusion Criteria:

          1. AIH diagnosed per International Autoimmune Hepatitis Group

          2. Liver biopsy with Ishak modified HAI indicating active AIH

          3. Incomplete response to OR intolerance of standard therapy (per AASLD)

        Key Exclusion Criteria

          1. 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

          2. Required regular use of medications with known hepatotoxicity

          3. Decompensated cirrhosis

          4. Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC).

          5. Drug related AIH at screening or a history of drug related AIH.

          6. History of drug abuse or unhealthy alcohol use

          7. History of malignancy of any organ system

          8. Pregnant or nursing (lactating) women




18 Years - 75 Years

Accepts Healthy Volunteers



Marcos Pedrosa, M.D., 1-888-669-6682, [email protected]

Location Countries


Location Countries


Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

Novartis Pharmaceuticals

Study Sponsor

Marcos Pedrosa, M.D., Study Director, Novartis Pharmaceuticals

Verification Date

November 2021