ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

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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
      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.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

ALT (Alanine aminotransferase) normalization

Secondary Outcome

 ALT normalization by dose

Condition

Autoimmune Hepatitis

Intervention

VAY736

Study Arms / Comparison Groups

 Arm 1
Description:  VAY736 Dose 1

Publications

* 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

Biological

Estimated Enrollment

80

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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

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

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT03217422

Organization ID

CVAY736B2201

Secondary IDs

2017-001555-32

Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals


Study Sponsor

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


Verification Date

November 2021