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

Recruiting in Palo Alto (17 mi)

+102 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-1)

Eligibility Criteria

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.

Inclusion Criteria

Signed informed consent must be obtained prior to participation in the study

I am 18 years old or older.

Patients negative for anti-Ro/SSA antibody are eligible, if they have a positive salivary gland biopsy confirmed by central expert review

+10 more

Exclusion 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.

+22 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm AExperimental Treatment1 Intervention

ianalumab

Group II: Arm BPlacebo Group1 Intervention

placebo