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Monoclonal Antibodies
Ianalumab for Sjögren's Syndrome (NEPTUNUS-1 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
Patients taking hydroxychloroquine (≤ 400 mg/day), methotrexate (≤ 25 mg/week) or azathioprine (≤ 150 mg/day) alone or in combination, are allowed to continue their medication, and must have been on a stable dose for at least 30 days prior to randomization
Time since diagnosis of Sjögren's of ≤ 7.5 years at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion upto 2 years
Awards & highlights
NEPTUNUS-1 Trial Summary
This trial is testing whether ianalumab is an effective and safe treatment for patients with active Sjögren's syndrome.
Who is the study for?
Adults with active Sjogren's Syndrome, diagnosed within the last 7.5 years and meeting specific criteria including certain symptom scores and antibody presence or positive biopsy. Stable doses of some medications like hydroxychloroquine, methotrexate, or low-dose corticosteroids are allowed. Exclusions include recent B-cell therapy use, significant lab abnormalities, dryness-causing medication changes, immunodeficiencies, chronic infections like hepatitis or TB, pregnancy/breastfeeding without contraception use.Check my eligibility
What is being tested?
The trial is testing Ianalumab (VAY736), a potential new treatment for Sjogren's Syndrome against a placebo in a randomized double-blind setup to evaluate its effectiveness and safety. Participants will be randomly assigned to either receive Ianalumab or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Potential side effects of Ianalumab may include reactions related to the immune system such as increased risk of infections due to lowered immunity. As it targets B-cells specifically involved in autoimmune responses there could also be infusion-related reactions and possible impacts on blood cell counts.
NEPTUNUS-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a stable dose of hydroxychloroquine, methotrexate, or azathioprine for at least 30 days.
Select...
I was diagnosed with Sjögren's syndrome less than 7.5 years ago.
Select...
I tested positive for the anti-Ro/SSA antibody.
Select...
I have stopped taking certain arthritis medications or specific Chinese medicines as required, except for leflunomide which I stopped 8 weeks ago or did a special wash-out for.
NEPTUNUS-1 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 Sjogren 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
Disease
+6 moreOther outcome measures
Ianalumab concentration in serum during the treatment and follow-up (up to end of study)
Incidence of Treatment Emergent Adverse Event (TEAEs)/Serious Adverse Events (SAEs) upto the end of the study
Incidence of anti-ianalumab antibodies in serum Anti Drug Antibody (ADA) assay) up 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-1 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm AExperimental Treatment1 Intervention
ianalumab
Group II: Arm BPlacebo 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
2,856 Previous Clinical Trials
4,197,437 Total Patients Enrolled
6 Trials studying Sjögren's Syndrome
1,486 Patients Enrolled for Sjögren's Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a major organ, stem cell, or bone marrow transplant.I do not have active hepatitis C or have cleared the virus after treatment.I have not had any cancer, except for skin basal cell carcinoma, cervical cancer in situ, or Sjögren's related lymphoma, in the last 5 years.I am 18 years old or older.I have been treated with ianalumab before.I am on a stable dose of hydroxychloroquine, methotrexate, or azathioprine for at least 30 days.I can communicate well and follow the study's requirements.I have not received a live vaccine in the last 4 weeks.I haven't used B-cell depleting therapy other than ianalumab in the last 36 weeks.I have been on a stable dose of my eye prescription, excluding lubricants, for 90 days.I am not allergic to the study drug or similar medications.I haven't taken any experimental drugs recently.I am taking more than 10 mg/day of corticosteroids.I have been on a stable dose of hydroxychloroquine, methotrexate, or azathioprine for at least 30 days.My main illness is an active autoimmune rheumatic disease.I do not have active hepatitis B.I haven't taken certain immune system affecting drugs recently.I do not have any current infections needing treatment or a history of serious or repeated infections.I have a history of sarcoidosis.I take medication that causes dry mouth/eyes and haven't been on a stable dose for 30 days.I do not have hepatitis B but may have hepatitis C or chronic hepatitis.I am using effective birth control and will continue for 6 months after treatment.I was diagnosed with Sjögren's syndrome less than 7.5 years ago.I agree to use barrier protection during sex while on the study treatment.I tested positive for the anti-Ro/SSA antibody.I do not have active tuberculosis but may have had it or latent TB in the past.I have stopped taking certain arthritis medications or specific Chinese medicines as required, except for leflunomide which I stopped 8 weeks ago or did a special wash-out for.I have been on a stable dose of corticosteroids (≤10 mg/day) for at least 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
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: NCT05350072 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the risks associated with Arm A of the clinical trial?
"Arm A is backed by Phase 3 trial data, which suggests that it is safe. Our team at Power rates Arm A's safety as a 3."
Answered by AI
Is this study happening at multiple research facilities across the country?
"At the moment, this clinical trial is enrolling patients from 5 different hospitals. 3 of these locations are in Van Nuys, Dallas and Dayton. The other 2 sites have yet to be announced. If you are considering participating in this trial, please look into the location of the hospital to reduce travel time."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
Other
California
Arizona
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?
1
0
Why did patients apply to this trial?
Along with volunteering to help find a solution. I am a nurse so I understand the value of research.
PatientReceived 2+ prior treatments
Because I was just diagnosed with the Sjongren Syndrome. I have dry mouth forever. Don't know if I have the exact diagnosis you are looking for.
PatientReceived 1 prior treatment
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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