ADCC Mediated B-Cell dEpletion and BAFF-R Blockade (AMBER)
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ClinicalTrials.gov Identifier: NCT03217422 |
Recruitment Status :
Recruiting
First Posted : July 14, 2017
Last Update Posted : December 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autoimmune Hepatitis | Biological: VAY736 Other: Placebo | Phase 2 Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double blind, placebo-controlled |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of VAY736 in Autoimmune Hepatitis |
Actual Study Start Date : | February 15, 2018 |
Estimated Primary Completion Date : | July 4, 2025 |
Estimated Study Completion Date : | July 4, 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1
VAY736 Dose 1
|
Biological: VAY736
VAY736 |
Experimental: Arm 2
VAY736 Dose 2
|
Biological: VAY736
VAY736 |
Experimental: Arm 3
VAY736 Dose 3
|
Biological: VAY736
VAY736 |
Placebo Comparator: Arm 4
Placebo
|
Other: Placebo
Placebo control with conversion to active VAY736 |
- ALT (Alanine aminotransferase) normalization [ Time Frame: Week 24 ]Difference in ALT normalization
- ALT normalization by dose [ Time Frame: Week 24 ]VAY736 dose-response

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key 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)
Key Exclusion Criteria
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217422
Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com | |
Contact: Novartis Pharmaceuticals | +41613241111 |

Study Director: | Marcos Pedrosa, M.D. | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03217422 |
Other Study ID Numbers: |
CVAY736B2201 2017-001555-32 ( EudraCT Number ) |
First Posted: | July 14, 2017 Key Record Dates |
Last Update Posted: | December 2, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Type 1, Type 2, autoimmune hepatitis, AIH, |
Hepatitis A Hepatitis Hepatitis, Autoimmune Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepatitis, Chronic Autoimmune Diseases Immune System Diseases |