DAFFODIL
Research type
Research Study
Full title
A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults with Moderate to Severe Sjogren's Disease (SjD)
IRAS ID
1010975
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2024-513965-38
ISRCTN Number
ISRCTN14534389
Research summary
Sjogren's Disease (SjD) is a chronic (long-term), progressive, autoimmune disease (body’s immune system attacking normal tissue) in which circulating immunoglobulin (IgG) autoantibodies* activate the immune system including B-cells (type of white blood cells called lymphocytes) causing blood vessel damage & local destruction of exocrine glands**causing dryness, fatigue, pain & problems of skin, muscle & internal organs. Current approved treatments only alleviate the symptoms of dryness. There is no treatment approved for individuals with SjD & guidelines recommend use of immunosuppressive therapy (treatment to suppress body’s immune system).
*Type of proteins produced by immune system that mistakenly attack body's own cells & tissues.
**Glands responsible for producing tears & saliva.
Nipocalimab (JNJ-80202135/JNJ-86507083) is a monoclonal antibody that selectively blocks the IgG binding site called endogenous neonatal fragment crystallizable receptor resulting in decrease in circulating IgG, thus reducing inflammatory immune response to the harmful IgG in the body.
In this study, researchers want to learn how well nipocalimab works and how safe it is in participants with moderate to severe SjD compared to placebo.
Participants will be randomly (by chance) assigned to one of the 2 identical studies (conducted under this single protocol).
Study will consist of:
1. Screening period (up to Week 6)
2. Double blind treatment period (up to Week 48): Participants in the 2 studies will be randomly assigned to arms below to receive assigned intervention:
o Arm A: Nipocalimab
o Arm B: Placebo
3. Open-label extension (up to Week 150): Participants will be given an option to continue nipocalimab.
4. Safety follow-up (up to Week 156)
Safety assessments include monitoring of adverse events (AEs), SAEs, participant & investigator reported questionnaires, & blood tests. All side effects will be recorded till the study ends (approximately 3 years).REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
24/EM/0261
Date of REC Opinion
23 Dec 2024
REC opinion
Further Information Favourable Opinion