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NCT05349214 Clinical Trial

Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

Sjogren Syndrome Clinical Trial

— NEPTUNUS-2  

Official title:
A Randomized, Double-blind, Placebo Controlled, 3-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-2)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05349214
Other study ID # CVAY736A2302
Secondary ID 2021-005687-22
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 4, 2022
Est. completion date March 9, 2028

Study information
Verified date June 2024
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email novartis.email@novartis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)

Description:

Three-arm study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome. The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of ianalumab (VAY736) administered subcutaneously (s.c.) monthly or every 3 months compared to placebo in patients with active Sjogren's syndrome.

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Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• VAY736
ianalumab s.c.
• VAY736
ianalumab s.c.
Other:
• Placebo
placebo s.c.
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Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Lebanon,  Mexico,  Poland,  Romania,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Other Incidence of Treatment-emergent AEs (TEAEs) /SAEs (Serious Adverse Event) upto the end of the study Safety (Plan A and B) through study completion upto 2 years
Other Incidence of anti-ianalumab antibodies in serum Anti Drug Antibody (ADA) assay to end of study Immunogenicity (Plan A and B) through study completion up to 2 years
Other Ianalumab concentration in serum during the treatment and follow-up (up to the end of study) Pharmacokinetics (Plan A and B) through study completion up to 2 years
Primary Change from baseline in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo Efficacy (Plan A: US and US reference countries and Plan B: EU, other non-US Regions and EU reference countries)
Dose response measured by change multi-dimensional disease activity as assessed by the physician. Score range is 0-123. Higher scores on the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states A negative change from baseline indicates improvement in disease status.		 48 weeks
Secondary Proportion of patients achieving =3 points reduction from baseline in ESSDAI score at Week 48 Efficacy (Plan A and B)
Dose response measured by change multi-dimensional disease activity as assessed by the physician. Score range is 0-123. Higher scores on the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states A negative change from baseline indicates improvement in disease status.		 48 weeks
Secondary Proportion of patients achieving ESSDAI<5 at Week 48 Efficacy (Plan A and B)
Dose response measured by change multi-dimensional disease activity as assessed by the physician. Score range is 0-123. Higher scores on the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states A negative change from baseline indicates improvement in disease status.		 48 weeks
Secondary Proportion of patients achieving =3 points reduction from baseline in ESSDAI score at Week 24 Efficacy (Plan A and B) 24 weeks
Secondary Proportion of patients achieving meaningful improvement in the Sjogren's Syndrome Symptom Diary (SSSD) score at Week 48 Efficacy (Plan A)
The Sjogrens Syndrome Symptom Diary (SSSD) is questionnaire consists of five (six for females) questions about symptoms of Sjögren's syndrome, each question given a score of 0-10 (0=no symptoms, 10=worst possible symptoms) where patient choose the one response that best describes how severe the symptom was at its worst in the PAST 24 HOURS. It includes six symptom items (eye dryness, mouth dryness, skin dryness, physical fatigue, muscle and/or joint pain, genital dryness), and applies a recall period of 24 hrs. The aim of the SSSD is to establish patient reported endpoints for the treatment of Sjogrens syndrome. Participants will complete the diary daily for 7 days prior to the scheduled dosing.		 48 weeks
Secondary Change from baseline in stimulated whole salivary flow rate at Week 48 Efficacy (Plan A and B)
Both the amount and composition of saliva has been shown to reflect the glandular damage caused by the disease process of Sjögren's (Pijpe et al 2007). Unstimulated and stimulated salivary secretions are collected over 5 minutes. As much as possible the assessments are to be performed at a fixed time of the day to minimize fluctuations related to the circadian rhythm of salivary flow and composition (Dawes 1972).		 48 weeks
Secondary Change from baseline in Physician's Global Assessment (PhGA) of disease activity at Week 48 Efficacy (Plan A and B)
Physician global assessment of disease activity is made with relation to Sjögren's syndrome. Physician's global assessment (PhGA) of disease activity for Sjögren's syndrome is performed using 3 separate scales:
Visual Analog Scale (VAS) - an unnumbered 100 mm long horizontal line ranging from "no disease activity' to "maximal disease activity". The assessment of patient's condition on the day is made by placing a vertical mark across the line.
Numerical Rating Scale (NRS) - a segmented numeric version of the VAS. A respondent needs to select a whole number (0-10 integers), with 0 being "no disease activity" and 10 being "maximal disease activity".
4-point Likert scale - The level of disease activity is assessed on a scale from "inactive" to "high activity".		 48 weeks
Secondary Change from baseline in Patient's Global Assessment (PaGA) of disease activity at Week 48 Efficacy (Plan A and B)
Patient's global assessment (PaGA) of disease activity for Sjögren's syndrome is performed using 3 separate scales:
Visual Analog Scale (VAS) - an unnumbered 100 mm long horizontal line ranging from "very good' to "very poor". The assessment is made by placing a vertical mark across the line.
Numerical Rating Scale - a segmented numeric version of the VAS. A respondent needs to select a whole number (0-10 integers), with 0 being "very poor" and 10 being "very good".
4-point Likert scale - The level of symptom severity is assessed on a scale from "none to severe".		 48 weeks
Secondary Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48 Efficacy (Plan A and B)
The Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F version 4) is a short, 13-item, easy-to-administer tool that measures an individual's level of fatigue during their usual daily activities over the past week (Webster et al 2003). The level of fatigue is measured on a 5-point Likert scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much).		 48 weeks
Secondary Proportion of patients achieving = 1 point or 15% reduction from baseline in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) at Week 48 Efficacy (Plan B)
ESSPRI is an established disease outcome measure for Sjögren's (Seror et al 2011, Seror et al 2015). It consists of three domains of dryness, pain and fatigue.
The subject assesses severity of symptoms they experience on a single 0-10 numerical scale for each of the three domains. The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain + fatigue) /3. ESSPRI will be applied to the study patients at during runin period, at baseline and during study treatment.		 48 weeks
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