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A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease

RecruitingPhase 2Ages 18 Years - 100 YearsAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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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What it tests

  • DDY391
  • Placebo
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Where

22 sites
Clinical Res Of W Florida
Clearwater, United States
Clinical Research of West Florida Inc
Tampa, United States
Chicago Clinical Research Inst
Chicago, United States
Willow Rheumatology Wellness
Willowbrook, United States
RAO Research LLC
Oklahoma City, United States
Altoona Center for Clin Res
Duncansville, United States
Stryde Research-Allen Arthritis
Allen, United States
Novel Research LLC
Bellaire, United States

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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