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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well DDY391 works and how safe it is for people with Sjögren’s disease over up to 52 weeks. It also compares doses to help choose a dose for a future study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must have Sjögren’s disease that meets the study’s diagnosis rules at screening.
  • You must have anti-Ro (SSA) antibodies, which are immune proteins found in a blood test. If you do not, a past biopsy (tissue sample) must show swelling in saliva glands that fits Sjögren’s disease.

Who can't join

  • You have another active autoimmune rheumatic disease as your main illness. This is a disease where the immune system attacks joints or other body tissues.
  • You take more than 400 mg of hydroxychloroquine a day. If you take 400 mg or less, your dose must stay the same for at least 4 weeks before you are assigned to a study group.
  • In the 3 months before study group assignment, you received certain immune-system treatments. These include belimumab, abatacept, anti-TNF drugs, immunoglobulins, plasmapheresis (a blood-filtering treatment), cyclophosphamide, mycophenolate mofetil, cyclosporine A, or other drugs that lower immune activity.
  • You received treatment that removes certain immune cells, such as anti-CD20, less than 12 months before screening.
  • You have any infection at screening or study group assignment, or a history of repeated serious infections or repeated bacterial infections.
  • You had cancer within 5 years before study group assignment, or have cancer that is not in remission. Remission means signs of cancer have decreased or disappeared. Exceptions include localized non-melanoma skin cancer and cervical cancer that has not spread beyond its starting layer.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (9)

FL

IL

OK

PA

TX