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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
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
VAY736 dose testing; VAY736 efficacy and safety testing.

Condition or disease Intervention/treatment Phase
Autoimmune Hepatitis Biological: VAY736 Other: Placebo Phase 2 Phase 3

Detailed 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.

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. ALT (Alanine aminotransferase) normalization [ Time Frame: Week 24 ]
    Difference in ALT normalization


Secondary Outcome Measures :
  1. ALT normalization by dose [ Time Frame: Week 24 ]
    VAY736 dose-response


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Marcos Pedrosa, M.D. Novartis Pharmaceuticals
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Type 1, Type 2, autoimmune hepatitis, AIH,
Additional relevant MeSH terms:
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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