* NEPTUNUS-2
Research type
Research Study
Full 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 Sjögren’s syndrome (NEPTUNUS-2)
IRAS ID
1005468
Contact name
Claus-Peter Danzer
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-005687-22
Clinicaltrials.gov Identifier
Research summary
The objective of this trial is to demonstrate the clinical efficacy (how well it works), safety and tolerability of ianalumab 300 mg monthly or every 3 months compared to placebo in patients with active Sjögren’s syndrome.
Ianalumab (also referred to as VAY736) is type of biological drug called a monoclonal antibody, and is given in form of injections under the skin. It acts on B-lymphocytes (also called B-cells), a type of white blood cells that make antibodies. Ianalumab binds to a receptor for B-cell Activating Factor (BAFF) that is displayed on the surface of B-cells. By doing so, it reduces activity of B-cells and in addition, it initiates a cascade of events that destroy the B-cells that ianalumab is attached to. Because overactivation of B-cells plays a key role in Sjögren’s syndrome, treatment with ianalumab may potentially be effective in reducing the disease activity.Patients will have a 2/3 possibility of receiving ianalumab and a 1 in 3 chance of receiving placebo. While on study, patients can continue their usual eye drops, artificial tears/saliva, salivary stimulants and some other treatments.
Patients will be in the study for up to 3 years. The planned duration of the treatment period is 1 year (52 weeks), after completion of which, patients will enter a post-treatment follow-up period for up to 2 years. During the year of treatment, patients will see the Study Doctor every month (about 13 times). In post-treatment follow-up up, the five initial visits will be planned every month, but subsequent visits will be less frequent (3-6 months apart). Follow up is an important aspect of the trial, as the Study Doctor will need to confirm B-cells numbers (and therefore the immune system) recover.
Procedures will include: blood and urine samples; tests of salivary glands and tear gland function; health status checks; physical examination; various questionnaires related to their experience of living with Sjögren’s syndrome
REC name
London - Dulwich Research Ethics Committee
REC reference
22/FT/0062
Date of REC Opinion
6 Jun 2022
REC opinion
Further Information Favourable Opinion