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ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

NCT ID: NCT03217422

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2025-12-25

Brief Summary

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VAY736 dose testing; VAY736 efficacy and safety testing.

Detailed Description

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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

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Autoimmune Hepatitis

Keywords

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Type 1 Type 2 autoimmune hepatitis AIH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double blind, placebo-controlled

Study Groups

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Arm 1

VAY736 Dose 1

Group Type EXPERIMENTAL

VAY736

Intervention Type BIOLOGICAL

VAY736

Arm 2

VAY736 Dose 2

Group Type EXPERIMENTAL

VAY736

Intervention Type BIOLOGICAL

VAY736

Arm 3

VAY736 Dose 3

Group Type EXPERIMENTAL

VAY736

Intervention Type BIOLOGICAL

VAY736

Arm 4

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo control with conversion to active VAY736

Interventions

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VAY736

VAY736

Intervention Type BIOLOGICAL

Placebo

Placebo control with conversion to active VAY736

Intervention Type OTHER

Eligibility Criteria

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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)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Southern California Research Center

Coronado, California, United States

Site Status

Inland Empire Liver Foundation

Rialto, California, United States

Site Status

University of California Davis Medical Center

Sacramento, California, United States

Site Status

St. Lukes Advanced Liver Therapies

Houston, Texas, United States

Site Status

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

CABA, , Argentina

Site Status

Novartis Investigative Site

Ghent, , Belgium

Site Status

Novartis Investigative Site

Edmonton, Alberta, Canada

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Prague, , Czechia

Site Status

Novartis Investigative Site

Würzburg, Bavaria, Germany

Site Status

Novartis Investigative Site

Aachen, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Mainz, , Germany

Site Status

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status

Novartis Investigative Site

Takamatsu, Kagawa-ken, Japan

Site Status

Novartis Investigative Site

Itabashi Ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Bern, , Switzerland

Site Status

Novartis Investigative Site

Birmingham, West Midlands, United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

Newcastle upon Tyne, , United Kingdom

Site Status

Novartis Investigative Site

Nottingham, , United Kingdom

Site Status

Novartis Investigative Site

Oxford, , United Kingdom

Site Status

Countries

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Denmark Netherlands Singapore Sweden United States Argentina Belgium Canada Czechia Germany Japan Spain Switzerland United Kingdom

References

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Cholankeril G, Vierling JM. The clinical imperative of a complete biochemical response to immunosuppression in autoimmune hepatitis: Close is not good enough! Hepatology. 2024 Mar 1;79(3):529-531. doi: 10.1097/HEP.0000000000000597. Epub 2023 Sep 18. No abstract available.

Reference Type DERIVED
PMID: 37722131 (View on PubMed)

Chung YY, Rahim MN, Heneghan MA. Autoimmune hepatitis and pregnancy: considerations for the clinician. Expert Rev Clin Immunol. 2022 Apr;18(4):325-333. doi: 10.1080/1744666X.2022.2044307. Epub 2022 Mar 2.

Reference Type DERIVED
PMID: 35179437 (View on PubMed)

Other Identifiers

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2023-508859-39-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CVAY736B2201

Identifier Type: -

Identifier Source: org_study_id