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New monthly shot could ease Sjögren's dry mouth

NCT ID NCT07621809

Symptom relief Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 7 times

Summary

This phase 3 study tests whether ianalumab, given as a monthly injection, can reduce dry mouth and other symptoms in people with Sjögren's disease who have a high symptom burden. About 570 adults will receive either the drug or a placebo for 52 weeks. The main goal is to see if the drug improves mouth dryness compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ianalumab (VAY736)
What this could lead to
If it works, this could provide a new monthly injection to significantly reduce dry mouth and other Sjögren's symptoms.
What could go wrong
This is a phase 3 trial, but results are not yet known. The drug may not improve symptoms more than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 570 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Aug 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female participants ≥ 18 years of age or as per country-specific legal adult age, whichever is higher * Classification of Sjögren's disease according to ACR/EULAR 2016 criteria. * Seropositive for anti-Ro/SSA antibodies at screening * SSSD oral dryness score ≥ 5 and overall SSSD summary score ≥5 collected over 14 consecutive days during the Screening 2 period * Screening ESSDAI biologic and/or hematologic domain \> 0 Note: laboratory abnormalities for scoring must be confirmed as associated with Sjögren's disease and not be due to other underlying conditions. * Stimulated whole salivary flow (sSF) rate \> 0.3 mL/min at screening * Participants taking hydroxychloroquine (≤ 400 mg/day) are allowed to continue their medication, and must have been on a stable dose for at least 4 weeks prior to screening, which should be maintained throughout the 52 weeks of the blinded treatment period. * Predniso(lo)ne ≤ 5 mg/day or equivalent are allowed for up to 16 weeks post-randomization. Exclusion Criteria: * Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically: * Systemic sclerosis (SSc) * Any other associated connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease)) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's disease organ domain assessments. * Concurrent diagnosis or history of fibromyalgia or overlapping inflammatory diseases * Prior treatment with B-cell-depleting therapy (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) within: * 36 weeks prior to randomization, or * As long as B-cell count is less than the lower limit of normal (LLN) or baseline value prior to receipt of previous B-cell-depleting therapy (whichever is lower) at Screening. * Prior treatment with ianalumab * Prior treatment with any of the following within the given period prior to Screening: * Within 5 half-lives prior to Screening: iscalimab (anti-CD 40 mAb), belimumab (anti-BAFF mAb), abatacept (CTLA4-Fc Ig), anti-tumor necrosis factor alpha (TNFα) biologic agents, immunoglobulins (i.v./s.c.), plasmapheresis, any other investigational biologic medicines under investigation for Sjögren's disease * Within 4 weeks OR drug-specific 5 half-lives elimination period (if longer than 4 weeks) prior to screening: i.v. or oral cyclophosphamide, mycophenolate mofetil (MMF), methotrexate, azathioprine, i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors). * History of hypersensitivity to any of the study drugs or their excipients, or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug formulation (sucrose, L-histidine hydrochloride/L-histidine, polysorbate 20).

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Conditions

The condition(s) this trial relates to.

autoimmune disease Fatigue Sjogren syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sjögren's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abigail Neiman MD PA

    RECRUITING

    Houston, Texas, 77024, United States

  • Accurate Clinical Research

    RECRUITING

    League City, Texas, 77573, United States

  • Arthritis Care of Texas

    RECRUITING

    Corpus Christi, Texas, 78415, United States

  • Arthritis Northwest PLLC

    RECRUITING

    Spokane, Washington, 99216, United States

  • Clinical Res Of W Florida

    RECRUITING

    Clearwater, Florida, 33765, United States

  • Clinical Research Inst of MI

    RECRUITING

    Saint Clair Shores, Michigan, 48081, United States

  • Clinical Research of West Florida Inc

    RECRUITING

    Tampa, Florida, 33606, United States

  • Novartis Investigative Site

    RECRUITING

    Maroochydore, Queensland, 4558, Australia

  • Novartis Investigative Site

    RECRUITING

    Rimouski, Quebec, G5L 5T1, Canada

  • Novartis Investigative Site

    RECRUITING

    Gwangju, 61469, South Korea

  • Novel Research LLC

    RECRUITING

    Bellaire, Texas, 77401, United States

  • On Site Clinical Solutions Llc

    RECRUITING

    Charlotte, North Carolina, 28202, United States

  • Precision Comprehensive Clinical Research Solutions

    RECRUITING

    Euless, Texas, 76040, United States

  • RAO Research LLC

    RECRUITING

    Oklahoma City, Oklahoma, 73116, United States

  • Shelby Research LLC

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Sun Valley Arthritis Center Ltd

    RECRUITING

    Peoria, Arizona, 85381, United States

  • TEKTON

    RECRUITING

    Leander, Texas, 78641, United States

  • West Tennessee Research Institute

    RECRUITING

    Jackson, Tennessee, 38305, United States

  • Willow Rheumatology Wellness

    RECRUITING

    Willowbrook, Illinois, 60527, United States

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