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A Phase 2a/b Study of DDY391 to Evaluate Efficacy, Safety and Tolerability in Adults with Sjögren's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study looks at people with Sjögren's Disease, an autoimmune condition that causes dry eyes, dry mouth and joint pain. The investigational drug being tested is called DDY391. The purpose of the study is to determine whether DDY391 can lower disease activity and lessen the symptoms compared with a placebo.

The trial is a randomized, double‑blind, Phase 2a/b design, meaning participants are assigned by chance to receive either DDY391 or a placebo and neither the participants nor the doctors know which one is given. Over about a year, participants will attend regular clinic visits where blood samples and questionnaires will be collected. Disease activity will be measured with the ESSDAI, a score that doctors use to rate how active the disease is, and symptom burden will be measured with the ESSPRI, a questionnaire about dryness, pain and fatigue, as well as a daily symptom diary called the SSSD. Safety will be checked by recording any unwanted side effects that occur during the study.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessment and Randomization

    You will attend an initial visit where your health status is recorded using questionnaires and clinical tests. The disease activity will be measured with the European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) and symptom burden with the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) and the Sjögren's Syndrome Symptom Diary (SSSD).

    Based on the baseline information, you will be randomly assigned to receive either the study drug DDY391 or a matching placebo. Neither you nor the study staff will know which one you receive.

  2. Step 2

    Start of Study Medication

    You will begin taking the assigned study medication as instructed by the study team. The medication will be taken for the duration of the trial, which includes at least 24 weeks for efficacy assessments and continues through week 52 for safety monitoring.

  3. Step 3

    Regular Follow‑Up Visits

    You will return to the clinic at scheduled intervals, such as week 4, week 12, and week 24. During each visit, the study staff will check your health, record any side effects, and repeat the questionnaires (ESSDAI, ESSPRI, SSSD) to track changes.

    Blood samples or other tests may be taken as needed to monitor safety, but the specific procedures will be explained by the study team.

  4. Step 4

    Primary Efficacy Assessment at Week 24

    At the 24‑week visit, the main effectiveness of the treatment will be evaluated. Changes from the baseline scores of the ESSDAI (disease activity) and the ESSPRI (symptom burden) will be measured.

  5. Step 5

    Continued Treatment and Safety Monitoring

    After the week 24 assessment, you will continue taking the study medication until week 52. Additional safety visits may be scheduled to record any treatment‑emergent adverse events (TEAEs) or serious adverse events (SAEs).

  6. Step 6

    Final Safety Visit at Week 52

    At week 52, a final visit will be performed to evaluate long‑term safety. The study staff will document any adverse events that occurred during the entire treatment period.

Who can join the trial?

11 criteria

  • Have a confirmed diagnosis of Sjögren's Disease using the ACR/EULAR 2016 classification criteria at the screening visit.
  • Show positive anti‑Ro (SSA) antibodies in a blood test, or if these antibodies are negative, have a recent (within two years) salivary gland biopsy that demonstrates inflammation consistent with the disease.
  • Be at least 18 years old and can be either male or female.
  • Present at screening with one or more of the following signs or symptoms:
    • Constitutional symptoms (general feelings such as fatigue or fever)
    • Lymphadenopathy (swollen lymph nodes)
    • Glandular problems (e.g., dry eyes or dry mouth)
    • Articular involvement (joint pain or swelling)
    • Cutaneous issues (skin rashes or lesions)
    • Renal involvement (kidney-related problems)
    • Hematological changes (abnormal blood test results)
    • Biologic findings (specific laboratory markers related to the disease)

Who cannot join the trial?

7 criteria

  • Having another active autoimmune rheumatic disease that is the main illness, meaning a condition where the immune system mistakenly attacks the body’s own joints or tissues.
  • Taking more than 400 mg per day of hydroxychloroquine, a medication commonly used to treat this condition.
  • Taking 400 mg or less of hydroxychloroquine but not staying on the same dose for at least four weeks before the study starts (a “stable dose”).
  • Having used any of the following strong immune‑affecting medicines within the past three months: belimumab, abatacept, anti‑tumor necrosis factor‑alpha (TNF‑α) biologic agents, immunoglobulins (antibody therapy), plasmapheresis (a procedure that filters blood), cyclophosphamide (taken by mouth or IV), mycophenolate mofetil, cyclosporine A, or any other immunosuppressants such as JAK inhibitors, IL‑2, anti‑IL‑6, and anti‑IL‑17 drugs.
  • Having received any cell‑depleting therapies (treatments that remove certain immune cells), including but not limited to anti‑CD20 therapy, less than 12 months before screening.
  • Having a current viral, bacterial, or other infection, or a history of frequent serious infections.
  • Having had a malignancy (cancer) in any organ within the last five years, except for a small non‑melanoma skin cancer or early‑stage (in situ) cervical cancer, or having any cancer that is not completely cured (not in remission).
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Investigated drugs

DDY391 is an experimental medication being tested to see if it can help people with Sjögren's Disease. In this study, participants receive DDY391 to find out whether it can lower the overall activity of the disease, improve the symptoms they feel, and be safe and well‑tolerated. The trial compares the effects of DDY391 with a placebo to determine if the medication provides real benefits for reducing disease activity and easing the burden of symptoms.

What is already known about the treatment

DDY391 - DDY391 is given as a subcutaneous injection that patients can receive at a clinic or at home using a prefilled pen. It is an experimental biologic currently being studied in Phase 2 trials and is not yet approved for routine medical use. The drug is being tested for people with Sjögren’s disease to lower disease activity and relieve symptoms such as dry eyes and dry mouth. It works by blocking a key protein that drives the over‑active immune response, placing it in the class of immunomodulatory monoclonal antibodies.

Investigated diseases

Sjögren's syndrome - Sjögren's syndrome is an autoimmune disorder that primarily affects the glands that produce moisture, leading to dry eyes and dry mouth. Over time, the reduced secretions can cause difficulty swallowing, speaking, and maintaining oral health. The condition may also involve other organs such as the joints, lungs, kidneys, and nervous system, causing joint pain, fatigue, and occasional swelling. Symptoms often develop gradually and can fluctuate in intensity. The disease activity can be measured by changes in specific clinical scores that reflect organ involvement and patient‑reported symptoms. Progression varies among individuals, with some experiencing stable symptoms while others notice worsening dryness and systemic involvement.
Trial detailsLast updated 18 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524513-92-00Protocol codeCDDY391B12201Estimated enrolment286 patientsSponsorNovartis Pharma AG

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