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)

Phase 2

Withdrawn

Conditions: Autoimmun hepatitis
10003816

Registration Number: NL-OMON48945

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

- AIH diagnosed per International Autoimmune Hepatitis Group
- Liver biopsy with Ishak modified HAI score equal or above 5
- Incomplete response to OR intolerance of standard therapy (per AASLD)

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 1:<br /><br>To determine effects of different ianalumab doses on ALT normalization at Week<br /><br>24 in patients with AIH who are incomplete responders or intolerant to standard<br /><br>therapy.<br /><br><br /><br>Part 2:<br /><br>To confirm the efficacy (biochemical and histological remission) and safety of<br /><br>the dose determined from Part 1 in this population.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part 1:<br /><br>To evaluate the dose-response relationship of VAY736 with respect to<br /><br>normalization in ALT at Week 24.<br /><br><br /><br>Part 2:<br /><br><br /><br>To demonstrate that VAY736 improves normalization of ALT at Week 52 relative to<br /><br>placebo<br /><br>To demonstrate histological remission with VAY736 at Week 52 relative to placebo<br /><br>To demonstrate the effect of VAY736 on FACIT-F patient reported outcome measure<br /><br>at Week 52 relative to placebo</p><br>