Testing DDY391 Against Placebo in Adults With Sjögren's Disease
Tests DDY391 compared with placebo in adults with Sjögren's disease.
Plain-language title generated from the registry record
Registry title: A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
Key facts
- Where
- Kosice - Stare Mesto, Nove Mesto Nad Vahom, Poprad, and Trnava, SlovakiaSee the 4 sites
- Phase
- Phase 2
AI summary: who the study is looking for
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
Read by machine on 10 November 2026.
Could this be for you?
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?
Source: NCT07737743, who can take part
Where in Slovakia
- Zazabie s.r.o.Kosice - Stare Mesto, SlovakiaNot yet recruiting
- Reum.hapi s.r.o.Nove Mesto Nad Vahom, SlovakiaNot yet recruiting
- REUMAMED POPRAD, s.r.o.Poprad, SlovakiaNot yet recruiting
- Reuma Global s.r.o.Trnava, SlovakiaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07737743EU 2025-524513-92-00
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.