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ADCC Mediated B-Cell dEpletion and BAFF-R Blockade (AMBER)

Primary Purpose

Autoimmune Hepatitis

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

VAY736

Placebo

About this trial

This is an interventional treatment trial for Autoimmune Hepatitis focused on measuring Type 1, Type 2, autoimmune hepatitis, AIH

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

AIH diagnosed per International Autoimmune Hepatitis Group
Liver biopsy with Ishak modified HAI indicating active AIH
Incomplete response to OR intolerance of standard therapy (per AASLD)

Key Exclusion Criteria

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
Required regular use of medications with known hepatotoxicity
Decompensated cirrhosis
Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC).
Drug related AIH at screening or a history of drug related AIH.
History of drug abuse or unhealthy alcohol use
History of malignancy of any organ system
Pregnant or nursing (lactating) women

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

VAY736 Dose 1

VAY736 Dose 2

VAY736 Dose 3

Placebo

Outcomes

Primary Outcome Measures

ALT (Alanine aminotransferase) normalization

Difference in ALT normalization

Secondary Outcome Measures

ALT normalization by dose

VAY736 dose-response

Full Information

NCT ID

NCT03217422

First Posted

July 12, 2017

Last Updated

October 17, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03217422

Brief Title

ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

Acronym

AMBER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 15, 2018 (Actual)

Primary Completion Date

December 29, 2023 (Anticipated)

Study Completion Date

December 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Hepatitis

Keywords

Type 1, Type 2, autoimmune hepatitis, AIH

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double blind, placebo-controlled

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

VAY736 Dose 1

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

VAY736 Dose 2

Arm Title

Arm 3

Arm Type

Experimental

Arm Description

VAY736 Dose 3

Arm Title

Arm 4

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Biological

Intervention Name(s)

VAY736

Intervention Description

VAY736

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo control with conversion to active VAY736

Primary Outcome Measure Information:

Title

ALT (Alanine aminotransferase) normalization

Description

Difference in ALT normalization

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

ALT normalization by dose

Description

VAY736 dose-response

Time Frame

Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: AIH diagnosed per International Autoimmune Hepatitis Group Liver biopsy with Ishak modified HAI indicating active AIH Incomplete response to OR intolerance of standard therapy (per AASLD) Key Exclusion Criteria 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 Required regular use of medications with known hepatotoxicity Decompensated cirrhosis Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC). Drug related AIH at screening or a history of drug related AIH. History of drug abuse or unhealthy alcohol use History of malignancy of any organ system Pregnant or nursing (lactating) women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Coronado

State/Province

California

ZIP/Postal Code

92118

Country

United States

Facility Name

Novartis Investigative Site

City

Rialto

State/Province

California

ZIP/Postal Code

92377

Country

United States

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1056ABJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 1R9

Country

Canada

Facility Name

Novartis Investigative Site

City

Vinohrady

ZIP/Postal Code

12000

Country

Czechia

Facility Name

Novartis Investigative Site

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Sapporo-city

State/Province

Hokkaido

ZIP/Postal Code

006-8555

Country

Japan

Facility Name

Novartis Investigative Site

City

Takamatsu city

State/Province

Kagawa

ZIP/Postal Code

760 8557

Country

Japan

Facility Name

Novartis Investigative Site

City

Itabashi ku

State/Province

Tokyo

ZIP/Postal Code

173 8606

Country

Japan

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

35179437

Citation

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.

Results Reference

derived

Learn more about this trial

ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

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ADCC Mediated B-Cell dEpletion and BAFF-R Blockade (AMBER)

Autoimmune Hepatitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial