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Monoclonal Antibodies

Ianalumab for Sjögren's Syndrome (NEPTUNUS-1 Trial)

Phase 3
Waitlist Available
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
Must not have
History of major organ, hematopoietic stem cell or bone marrow transplant
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer or Sjögren's related lymphoma), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion upto 2 years
Awards & highlights
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable dose of hydroxychloroquine, methotrexate, or azathioprine for at least 30 days.
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I was diagnosed with Sjögren's syndrome less than 7.5 years ago.
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I tested positive for the anti-Ro/SSA antibody.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a major organ, stem cell, or bone marrow transplant.
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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.
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I do not have active hepatitis C or have cleared the virus after treatment.
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I have been treated with ianalumab before.
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I have not received a live vaccine in the last 4 weeks.
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I am not allergic to the study drug or similar medications.
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I haven't taken any experimental drugs recently.
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I am taking more than 10 mg/day of corticosteroids.
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My main illness is an active autoimmune rheumatic disease.
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I do not have any current infections needing treatment or a history of serious or repeated infections.
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I have a history of sarcoidosis.
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I take medication that causes dry mouth/eyes and haven't been on a stable dose for 30 days.
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I do not have hepatitis B but may have hepatitis C or chronic hepatitis.
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I am using effective birth control and will continue for 6 months after treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion upto 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion upto 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in EULAR Sjogren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo
Secondary study objectives
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 more
Other study objectives
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 • NCT02149420
75%
Infusion related reaction
33%
Nasopharyngitis
17%
Headache
8%
Fatigue
8%
Back pain
8%
Rash
8%
Cystitis
8%
Conjunctivitis
8%
Sinusitis
8%
Iron deficiency anaemia
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 3
~790

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,911 Previous Clinical Trials
4,250,401 Total Patients Enrolled
6 Trials studying Sjögren's Syndrome
1,502 Patients Enrolled for Sjögren's Syndrome

Media Library

Ianalumab (VAY736) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05350072 — Phase 3
Sjögren's Syndrome Research Study Groups: Arm A, Arm B
Sjögren's Syndrome Clinical Trial 2023: Ianalumab (VAY736) Highlights & Side Effects. Trial Name: NCT05350072 — Phase 3
Ianalumab (VAY736) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05350072 — Phase 3
Sjögren's Syndrome Patient Testimony for trial: Trial Name: NCT05350072 — Phase 3
~42 spots leftby May 2025
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