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Monoclonal Antibodies
Ianalumab for Sjögren's Syndrome (NEPTUNUS-2 Trial)
Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Positive anti-Ro/SSA antibody at screening
Screening ESSDAI score of ≥ 5 within the following 8 domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematological and biologic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion upto 2 years
Awards & highlights
NEPTUNUS-2 Trial Summary
This trial is testing a potential new treatment for Sjögren's syndrome, and comparing it to a placebo and another existing treatment. It will assess how well it works and how safe it is.
Who is the study for?
Adults diagnosed with Sjogren's syndrome as per ACR/EULAR 2016, with symptoms for ≤7.5 years and a certain level of disease activity. Participants must not have used specific immunosuppressants recently and should be on stable doses of allowed medications like hydroxychloroquine or methotrexate.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of Ianalumab (VAY736) compared to a placebo in treating active Sjogren's syndrome. It's a phase 3 trial where patients are randomly assigned to one of three groups in a double-blind setting, meaning neither they nor the researchers know who gets the actual drug or placebo.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include reactions related to immune system alterations due to Ianalumab (a monoclonal antibody), such as infusion-related reactions, increased risk of infections, or possible hypersensitivity.
NEPTUNUS-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I tested positive for the anti-Ro/SSA antibody.
Select...
My ESSDAI score is 5 or higher in areas like glands, skin, or joints.
Select...
I am not currently taking certain arthritis medications or will stop them as required before joining the study.
NEPTUNUS-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion upto 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion upto 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo
Secondary outcome measures
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48
Change from baseline in Patient's Global Assessment (PaGA) of disease activity at Week 48
Change from baseline in Physician's Global Assessment (PhGA) of disease activity at Week 48
+6 moreOther outcome measures
Ianalumab concentration in serum during the treatment and follow-up (up to the end of study)
Incidence of Treatment-emergent AEs (TEAEs) /SAEs (Serious Adverse Event) upto the end of the study
Incidence of anti-ianalumab antibodies in serum Anti Drug Antibody (ADA) assay to end of study
Side effects data
From 2018 Phase 2 trial • 27 Patients • NCT0214942075%
Infusion related reaction
33%
Nasopharyngitis
17%
Headache
8%
Fatigue
8%
Cystitis
8%
Rash
8%
Sinusitis
8%
Iron deficiency anaemia
8%
Back pain
8%
Conjunctivitis
8%
Myalgia
8%
Gastroenteritis
8%
Gastrointestinal infection
8%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
VAY736 10mg/kg
VAY736 3mg/kg
Placebo
Open Label VAY736 10mg/kg
NEPTUNUS-2 Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm BExperimental Treatment1 Intervention
ianalumab exposure level 2
Group II: Arm AExperimental Treatment1 Intervention
ianalumab exposure level 1
Group III: Arm CPlacebo Group1 Intervention
placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VAY736
2014
Completed Phase 2
~290
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,197,755 Total Patients Enrolled
6 Trials studying Sjögren's Syndrome
1,265 Patients Enrolled for Sjögren's Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I tested negative for anti-Ro/SSA but my salivary gland biopsy is positive.I have not received a live vaccine in the last 4 weeks.I have previously been treated with ianalumab.I am using effective birth control and will continue for 6 months after treatment ends.I have had cancer in any part of my body in the last 5 years.I have been on a stable dose of hydroxychloroquine, methotrexate, or azathioprine for at least 30 days.I have chronic hepatitis B or C, but I am not HBsAg positive.I am taking more than 10 mg/day of corticosteroids.I do not have active hepatitis C or I have been cured of hepatitis C for at least 12 weeks.I have had a major organ, stem cell, or bone marrow transplant.I do not have an active tuberculosis infection.I am 18 years old or older.I tested positive for the anti-Ro/SSA antibody.I was diagnosed with Sjögren's syndrome less than 7.5 years ago.I haven't used B-cell depleting therapy other than ianalumab in the last 36 weeks.I do not have current infections needing treatment or a history of serious or repeated infections.I have a history of sarcoidosis.I do not have active hepatitis B.I haven't taken any experimental drugs recently.I take medication that causes dry mouth/eyes and haven't been on a stable dose for 30 days.I have been on a stable dose of my eye medication for at least 90 days.I am a sexually active male and agree to use barrier protection during the study.I don't have anti-Ro/SSA antibodies but my salivary gland biopsy was positive.My ESSDAI score is 5 or higher in areas like glands, skin, or joints.I have been on a stable dose of corticosteroids (≤10 mg/day) for at least 30 days.I am not currently taking certain arthritis medications or will stop them as required before joining the study.I don't have anti-Ro/SSA antibodies but my salivary gland biopsy was positive.I have not had certain treatments within specific timeframes.I tested positive for the anti-Ro/SSA antibody.You are able to communicate well with the Investigator, understand and agree to comply with the requirements of the study.You have a sSF rate of ≥ 0.05 mL/min at screening.I was diagnosed with Sjögren's syndrome less than 7.5 years ago.You have a clinical diagnosis of Sjögren's syndrome.I have been on a stable dose of hydroxychloroquine, methotrexate, or azathioprine for at least 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
- Group 3: Arm C
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Sjögren's Syndrome Patient Testimony for trial: Trial Name: NCT05349214 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA signed off on Arm A of this clinical trial?
"Arm A is safe according to our 3-point scale, as it is a Phase 3 trial with efficacy data as well as multiple rounds of safety data."
Answered by AI
Who else is applying?
What state do they live in?
Arkansas
Virginia
New Hampshire
Other
What site did they apply to?
Other
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
I have fry mouth. I have Sojogren's and am always looking for things to help myself & others.
PatientReceived 1 prior treatment
I feel like my symptoms have gotten worse in the last couple of years. In the last four months alone I have started having migraines and weird electric tingling/ cramping feelings in my feet.
PatientReceived 1 prior treatment
I have very dry eyes and am very sensitive to glare. I have trouble driving I get eye plugs but get very little relief. Generally my Sjogrens symptoms are getting worse with possible lung involvement.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Novartis Investigative Site: < 48 hours
Average response time
- < 2 Days
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