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Taking peoplePhase 2

Testing DDY391 Against Placebo in Adults With Sjögren's Disease

Tests DDY391 compared with placebo in adults with Sjögren's disease.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Plovdiv and Sofia, BulgariaSee the 2 sitesAlso in 18 other countries, 75 sites
Trial code
Registry title
A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
Status
Recruiting
Phase
Phase 2
People taking part
344 people, planned
Started
24 Aug 2026
Expected to end
19 Mar 2029
Type of study
Interventional, 8 groups
Treatments tested
  • DDY391
  • Placebo
Record updated
9 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Sjögren's disease. It tests DDY391 against placebo for up to 52 weeks.

Age
18 to 100 years
Sex
All sexes can join.
Disease stage
Sjögren's disease diagnosed by the ACR/EULAR 2016 classification criteria.
Earlier treatment
Hydroxychloroquine is allowed up to 400 mg/day, at a stable dose for at least 4 weeks before randomization. Several immune-suppressing drugs within 3 months before randomization are not allowed.
Biomarker or test result
Positive anti-Ro (SSA) antibodies at screening. Without these antibodies, a past biopsy must show salivary gland inflammation consistent with Sjögren's disease.

Main reasons for not taking part

  • Another active autoimmune rheumatic disease that is the main illness
  • Hydroxychloroquine above 400 mg/day
  • Belimumab, abatacept, anti-TNF drugs or other immunosuppressants within 3 months before randomization
  • Cell-depleting therapy such as anti-CD20 less than 12 months before screening
  • Current infection, or repeated serious infections

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Presence of another autoimmune rheumatic disease that is active at screening and constitutes the principal illness
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 100 years old?

Where in Bulgaria

Also in 18 other countries, 75 sites

  • University Multiprofile Hospital For Active Treatment Pulmed Ltd.Plovdiv, BulgariaNot yet recruiting
  • University Multiprofile Hospital For Active Treatment St. Ivan Rilski EADSofia, BulgariaNot yet recruiting

About the trial

What the trial wants to find out

To evaluate efficacy, safety, and tolerability of DDY391 up to 52 weeks in participants with Sjögren's disease (SjD) and to determine the dose response relationship of DDY391 in participants with SjD, to support dose selection for Phase 3.

The 8 groups in the trial

  • Part A- DDY391 dose level 1Treatment being tested

    DDY391 dose level 1

    Treatment: DDY391

  • Part A-PlaceboTreatment being tested

    Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.

    Treatment: DDY391 and Placebo

  • Part B- DDY391 dose level 1Treatment being tested

    DDY391 dose level 1

    Treatment: DDY391

  • Part B- DDY391 dose level 2Treatment being tested

    DDY391 dose level 2

    Treatment: DDY391

  • Part B- DDY391 dose level 3Treatment being tested

    DDY391 dose level 3

    Treatment: DDY391

  • Part B- PlaceboTreatment being tested

    Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.

    Treatment: DDY391 and Placebo

  • Part C- DDY391 dose level 1Treatment being tested

    DDY391 dose level 1

    Treatment: DDY391

  • Part C- PlaceboTreatment being tested

    Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.

    Treatment: DDY391 and Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2a/b Study Assessing the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
Plain-language title
Testing DDY391 Against Placebo in Adults With Sjögren's DiseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07737743, who can take part
Record updated
9 November 2026