Last Update: Sep 04, 2026 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 ClinicalTrials.gov Identifier: [NCT07737743](https://clinicaltrials.gov/ct2/show/NCT07737743) Novartis Reference Number:CDDY391B12201 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study 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. This study is a Phase 2a/b, randomized, double-blind, placebo-controlled, multi-center trial involving participants with SjD. The study consists of three parts (Part A, Part B, and Part C). The study includes a screening period of up to 8 weeks to assess eligibility, a 52-week treatment period, and a 4-week safety follow-up period after the last dose of study treatment. Condition Sjögren's Disease Phase Phase2 Overall Status Recruiting Number of Participants344 Start Date Aug 24, 2026 Completion Date Mar 19, 2029 Gender All Age(s) 18 Years - 100 Years (Adult, Older Adult) ## Interventions Drug ### DDY391 DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 Drug ### Placebo Matching Placebo ## Eligibility Criteria 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. Australia #### Novartis Investigative Site Recruiting Southport,Queensland,4222,Australia Canada #### Novartis Investigative Site Recruiting Sherbrooke,Quebec,J1g 2e8,Canada Israel #### 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 United States #### Clinical Research of West Florida Inc Recruiting Tampa,Florida,33603,United States ###### John Carter ###### Sydney K Mullen Phone: [+1 813 870 1292]() Email: #### RAO Research LLC Recruiting Oklahoma City,Oklahoma,73116,United States ###### Erica Beer Phone: [+1 405 608 8060]() Email: ###### Latisha Heinlen #### Novel Research LLC Recruiting Bellaire,Texas,77401,United States ###### Hassan Khan Phone: [+1 281 944 3610]() Email: ###### Wajeeha Yousaf ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: [](mailto:) #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: