Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Novartis Pharmaceuticals
+41613241111


Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com


Study Location:

Novartis Investigative Site
Birmingham
B15 2TH


Skip to Main Content

ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

Recruiting

Open to: All Genders

Age: 18 Years - 75 Years

Medical Conditions

Autoimmune Hepatitis


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




VAY736 dose testing; VAY736 efficacy and safety testing.

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.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Feb 2018

Jul 2025

Interventional

Intervention Type : Biological
Intervention Description : VAY736

Intervention Arm Group : Arm 1;Arm 2;Arm 3

Intervention Type : Other
Intervention Description : Placebo control with conversion to active VAY736

Intervention Arm Group : Arm 4

You can take part if:


Key Inclusion Criteria: 1. AIH diagnosed per International Autoimmune Hepatitis Group 2. Liver biopsy with Ishak modified HAI indicating active AIH 3. Incomplete response to OR intolerance of standard therapy (per AASLD) Key Exclusion Criteria 1. 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 2. Required regular use of medications with known hepatotoxicity 3. Decompensated cirrhosis 4. Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC). 5. Drug related AIH at screening or a history of drug related AIH. 6. History of drug abuse or unhealthy alcohol use 7. History of malignancy of any organ system 8. Pregnant or nursing (lactating) women




You may not be able to take part if:

This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Novartis Investigative Site
    Birmingham
    B15 2TH
  • Novartis Investigative Site
    Newcastle upon Tyne
    NE1 4LP
  • Novartis Investigative Site
    London
    SE5 9RS
  • Novartis Investigative Site
    Bradford
    West Yorkshire
    BD9 6RJ
  • Novartis Investigative Site
    Nottingham
    NG7 2UH
  • Novartis Investigative Site
    London
    NW3 2PF

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com


Novartis Pharmaceuticals
+41613241111



The study is sponsored by Novartis Pharmaceuticals .



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details

for Trial ID: NCT03217422

Last updated

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.