A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver

• Register: EUCTR
• Last refreshed on: 13 July 2020
• Main ID: EUCTR2017-001555-32-SE
• Date of registration: 02/11/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: A clinical trial to find out if VAY736 can help people with autoimmune hepatitis, a disease where your immune system attacks your own liver
• Scientific title: A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER
• Date of first enrolment: 19/12/2017
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001555-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Canada, Czech Republic, Denmark, Germany, Japan, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: Medical information
• Affiliation: Novartis Sverige AB

• Name: Medical information
• Affiliation: Novartis Sverige AB

Key inclusion & exclusion criteria

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)

Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
- Prior use of any B-cell depleting therapy
- 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
- Other protocol-defined exclusion criteria may apply


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Autoimmune Hepatitis (AIH)
MedDRA version: 20.1 Level: PT Classification code 10003827 Term: Autoimmune hepatitis System Organ Class: 10019805 - Hepatobiliary disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: ianalumab
Product Code: VAY736
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: ianalumab
CAS Number: Not establis
Current Sponsor code: VAY736
Other descriptive name: anti-BAFFR antibody
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Part 1: ALT normalization

Timepoint(s) of evaluation of this end point: 24 weeks

Main Objective: The purpose of the study is 2-fold:
Part 1- To determine effects of different ianalumab doses on ALT
normalization at Week 24 in patients with AIH who are incomplete
responders or intolerant to standard therapy.

Part 2 - To confirm the efficacy (biochemical and histological remission) and safety of the dose determined from Part 1 in this population.

Secondary Objective: Part 1 aims to evaluate the dose-response relationship of ianalumab with respect to normalization in ALT at Week 24.

Other protocol-defined secondary objectives may apply

Secondary Outcome(s)

Secondary end point(s): Part 1: ALT normalization by dose

Timepoint(s) of evaluation of this end point: 24 weeks

Secondary ID(s)

2017-001555-32-ES

NCT03217422

CVAY736B2201

Source(s) of Monetary Support

Novartis Pharma AG

Ethics review

Status: Approved
Approval date: 18/12/2017
Contact: