ADCC Mediated B-Cell dEpletion and BAFF-R Blockade (AMBER)
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- STATUS
- Recruiting
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- End date
- Dec 25, 2025
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- participants needed
- 80
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- sponsor
- Novartis Pharmaceuticals
Summary
VAY736 dose testing; VAY736 efficacy and safety testing.
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.
Details
| Condition | Autoimmune Hepatitis |
|---|---|
| Treatment | Placebo, VAY736 |
| Clinical Study Identifier | NCT03217422 |
| Sponsor | Novartis Pharmaceuticals |
| Last Modified on | 13 July 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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