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Can a new drug ease the dryness, pain, and fatigue of Sjögren's disease?

NCT ID NCT07737743

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Sep 10, 2026 · Updated 4 times

Summary

This phase 2 trial is testing whether an experimental drug called DDY391 can reduce disease activity and improve symptoms like dryness, pain, and fatigue in people with Sjögren's disease. About 344 participants will receive either DDY391 at one of three dose levels or a placebo for up to 52 weeks. The study aims to see if DDY391 can help control this autoimmune condition and to determine the best dose for future testing.

What this could mean

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

Active substance
an experimental drug called DDY391
What this could lead to
If DDY391 works, it could offer a new treatment option to reduce disease activity and improve daily symptoms like dryness, pain, and fatigue in people with Sjögren's disease.
What could go wrong
This is a mid-stage trial, so DDY391 may not prove effective or safe enough to move forward. Side effects are possible, and the drug may not work for everyone.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 344 people

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

Started

Aug 2026

Expected to finish

Mar 2029

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 to 100 years

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.

Key Inclusion Criteria: • Participants must have a diagnosis of SjD according to the ACR/EULAR 2016 classification criteria at screening: \- Positive anti-Ro (SSA) antibodies at screening. Participants negative for anti-Ro/SSA antibodies are eligible if they have documented previous biopsy showing evidence of salivary gland inflammation consistent with SjD. Key Exclusion Criteria: * Presence of another autoimmune rheumatic disease that is active at screening and constitutes the principal illness. * Exclusion based on medications being used for SjD: * Participants taking \> 400 mg/day hydroxychloroquine are excluded. Participants taking ≤400 mg/day hydroxychloroquine should be on a stable dose for at least 4 weeks prior to randomization. * Participants taking \> 400 mg/day hydroxychloroquine are excluded. Participants on ≤ 400 mg/day of hydroxychloroquine should be on a stable dose for at least 4 weeks prior to randomization. * Prior treatment with any of the following within 3 months prior to randomization: belimumab, abatacept, anti-tumor necrosis factor alpha biologic agents, immunoglobulins, plasmapheresis, intravenous (i.v.) or oral cyclophosphamide, mycophenolate mofetil, i.v. or oral cyclosporine A, or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors, IL-2, anti-IL-6, anti-IL-17). * Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20, unless ≥ 12 months prior to screening. * Any viral, bacterial or other infections at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infection. * History of malignancy of any organ system (other than localized non melanoma carcinoma of the skin or in situ cervical cancer) within the last five years of randomization or any malignancy not in remission. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

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

    9 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

  • Clinical Research of West Florida Inc

    RECRUITING

    Tampa, Florida, 33603, United States

  • Novartis Investigative Site

    RECRUITING

    Southport, Queensland, 4222, Australia

  • Novartis Investigative Site

    RECRUITING

    Sherbrooke, Quebec, J1G 2E8, Canada

  • Novartis Investigative Site

    RECRUITING

    Kfar Saba, 4428164, Israel

  • Novartis Investigative Site

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Novartis Investigative Site

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    RECRUITING

    Ẕerifin, 7030000, Israel

  • Novel Research LLC

    RECRUITING

    Bellaire, Texas, 77401, United States

  • RAO Research LLC

    RECRUITING

    Oklahoma City, Oklahoma, 73116, United States

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