Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS)

• Register: EUCTR
• Last refreshed on: 17 August 2021
• Main ID: EUCTR2016-003292-22-DE
• Date of registration: 06/03/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS)
• Scientific title: A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome
• Date of first enrolment: 06/06/2017
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003292-22
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Austria, Belgium, Chile, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
- Fulfilled revised American European US Consensus Group
criteria for pSS
- Seropositive at screening for anti-Ro/SSA antibodies

- 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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Primary Sjogren’s syndrome
MedDRA version: 21.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: ianalumab
Product Code: VAY736
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: ianalumab
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

Primary Outcome(s)

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

Timepoint(s) of evaluation of this end point: Over 24 weeks

Primary end point(s): Dose-response measured by change in multi-dimensional disease activity as assessed by the physician

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.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Over 24 weeks

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

Secondary ID(s)

NCT02962895

CVAY736A2201

Source(s) of Monetary Support

Novartis Pharma AG

Ethics review

Status: Approved
Approval date: 17/05/2017
Contact: