Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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21 March 2022 |
Main ID: |
EUCTR2016-003292-22-ES |
Date of registration:
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10/03/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS)
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Scientific title:
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A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome |
Date of first enrolment:
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06/04/2017 |
Target sample size:
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180 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003292-22 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Austria
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Belgium
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Chile
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France
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Germany
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Hungary
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Israel
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Italy
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Japan
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Netherlands
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Poland
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Portugal
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Romania
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Russian Federation
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Spain
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Taiwan
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United Kingdom
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United States
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Contacts
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Name:
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Departamento Médico (ICRO)
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Address:
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Gran Vía de les Corts Catalanes, 764
08013
Barcelona
Spain |
Telephone:
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+ 34 90 0353036 |
Email:
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eecc.novartis@novartis.com |
Affiliation:
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Novartis Farmacéutica, S.A. |
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Name:
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Departamento Médico (ICRO)
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Address:
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Gran Vía de les Corts Catalanes, 764
08013
Barcelona
Spain |
Telephone:
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+ 34 90 0353036 |
Email:
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eecc.novartis@novartis.com |
Affiliation:
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Novartis Farmacéutica, S.A. |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Fulfilled revised American European US Consensus Group criteria for pSS - Seropositive at screening for anti-Ro/SSA antibodies - Documented salivary/lacrimal gland biopsy result confirming pSS diagnosis prior to the baseline visit
- Other protocol-defined inclusion/exclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 126 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria: - Secondary Sjogren’s syndrome - Use of other investigational drugs - Active viral, bacterial or other infections - Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening
- Other protocol-defined inclusion/exclusion criteria may apply
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Primary Sjogren’s syndrome MedDRA version: 19.1
Level: PT
Classification code 10040767
Term: Sjogren's syndrome
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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Intervention(s)
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Product Code: VAY736 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Not established CAS Number: Not establis Current Sponsor code: VAY736 Other descriptive name: VAY736 antibody Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Secondary Objective: - To assess a dose response of VAY736 in the change from baseline of patient-reported disease activity measures at 24 weeks - To assess a dose response of VAY736 in the change from baseline of the patient reported outcomes at 24 weeks - To evaluate the effects of VAY736 on salivary gland function at 24 weeks - To assess PK of VAY736
Other protocol-defined secondary objectives may apply.
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Main Objective: To demonstrate a dose response of VAY736 defined as change in multi-dimensional disease activity as assessed by the physician from baseline at 24 weeks
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Primary end point(s): Dose-response measured by change in multi-dimensional disease activity as assessed by the physician
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Timepoint(s) of evaluation of this end point: Over 24 weeks
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Over 24 weeks
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Secondary end point(s): - Dose-response measured by change in patient-reported disease activity measures - Change in quality of life measured by PROs - Change in salivary gland function measured by flow rate - Pharmacokinetics of VAY736 over time - Assessment of AEs, SAEs, Immunogenicity
Other protocol defined endpoints may apply
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Secondary ID(s)
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2016-003292-22-DE
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CVAY736A2201
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Source(s) of Monetary Support
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Novartis Pharma AG
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Ethics review
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Status: Approved
Approval date: 14/03/2017
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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