A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome

Phase 1

• Conditions: Primary Sjogren’s syndrome; MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-003292-22-AT
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-17
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;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<br>- To assess a dose response of VAY736 in the change from baseline of the patient reported outcomes at 24 weeks<br>- To evaluate the effects of VAY736 on salivary gland function at 24 weeks<br>- To assess PK of VAY736 <br><br>Other protocol-defined secondary objectives may apply.;Timepoint(s) of evaluation of this end point: Over 24 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Dose-response measured by change in patient-reported disease activity measures<br>- Change in quality of life measured by PROs<br>- Change in salivary gland function measured by flow rate<br>- Pharmacokinetics of VAY736 over time<br>- Assessment of AEs, SAEs, Immunogenicity <br><br>Other protocol defined endpoints may apply;Timepoint(s) of evaluation of this end point: Over 24 weeks<br><br><br>