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)

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508859-39-00

Acronym

CVAY736B2201

Enrollment

Registered

2024-01-31

Start date

2018-02-15

Completion date

2025-12-17

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune hepatitis

Brief summary

Proportion of patients with normalization of ALT at Week 24

Detailed description

Proportion of patients achieving ALT normalization at Week 24

Interventions

DRUGPlacebo 0 mg/1 mL Solution for infusion/injection

DRUGVAY736

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of patients with normalization of ALT at Week 24	—

Secondary

Measure	Time frame
Proportion of patients achieving ALT normalization at Week 24	—

Countries

Czechia, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026