CVAY736A2301E1 Extension study
Research type
Research Study
Full title
A randomized, double-blind 2-arm NEPTUNUS extension study to assess the long-term safety and efficacy of ianalumab in patients with Sjögren’s syndrome
IRAS ID
1008498
Contact name
Daniel Monney
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2022-502966-26
Clinicaltrials.gov Identifier
N/A
Research summary
The purpose of this trial is to learn if continued treatment of the trial drug VAY736 (ianalumab) can help adults with Sjögren’s Syndrome who have completed treatment in one of two core VAY736 trials (CVAY736A2301 or CVAY736A2302). The trial is designed to learn more about extended treatment and the safety of VAY736. This trial is also designed to learn more about how effective VAY736 is in Sjögren’s Syndrome and how it affects how patients feel.
Sjögren’s syndrome is an autoimmune disorder, where there is an increase in the number of B-cells (a type of white blood cell in the immune system that makes antibodies attack foreign substances) in glands that produce fluid such as the tear and saliva (spit) glands. These B-cells produce antibodies that mistakenly attack these glands. Most common symptoms include dryness (dry mouth, dry eyes), tiredness, and muscle/bone pain. VAY736 is a drug designed to work by reducing the number of B-cells.
Participants will take part for up to 5 years. Treatment will be for 3 years, and follow-up period is up to 2 years after treatment. All participants will receive ianalumab. One group will receive an ianalumab 300 mg injection monthly for 3 years and the other group will receive an ianalumab 300 mg injection once every 3 months (with placebo injection every month between the ianalumab doses to maintain blinding – the participant and Study Doctor will not know what treatment group the participant is in).
Participants receiving placebo in either of the NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every 3 months starting from Week 60 and participants receiving ianalumab in either of the NEPTUNUS core studies will continue the same treatment in the extension study.
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
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
23/EE/0212
Date of REC Opinion
24 Oct 2023
REC opinion
Further Information Favourable Opinion