Sjögren's Disease study: DDY391
Official title A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
ClinicalTrials.gov ID: NCT07737743
What this study is testing
What is DDY391?
DDY391 is an investigational drug being studied as a potential treatment for Sjögren's disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will find out whether DDY391 is effective, safe, and well‑tolerated, and how different doses work over up to 52 weeks.
- Who it's for
- People who have been diagnosed with Sjögren's disease.
- What's involved
- Participants will take the study medication and have regular clinic visits and tests to check safety and how they feel.
- Time commitment
- The trial lasts up to 52 weeks with multiple scheduled visits during that time.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- \- Positive anti-Ro (SSA) antibodies at screening. Participants negative for anti-Ro/SSA antibodies are eligible if they have documented previous...
You likely can't join if
- Presence of another autoimmune rheumatic disease that is active at screening and constitutes the principal illness.
- Participants taking \> 400 mg/day hydroxychloroquine are excluded. Participants taking ≤400 mg/day hydroxychloroquine should be on a stable dose for...
- Participants taking \> 400 mg/day hydroxychloroquine are excluded. Participants on ≤ 400 mg/day of hydroxychloroquine should be on a stable dose for...
- Prior treatment with any of the following within 3 months prior to randomization: belimumab, abatacept, anti-tumor necrosis factor alpha biologic...
- 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...
See the full eligibility criteria
- \- 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...
- Presence of another autoimmune rheumatic disease that is active at screening and constitutes the principal illness.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Avondale, Arizona, United States
- Clearwater, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Willowbrook, Illinois, United States
- Oklahoma City, Oklahoma, United States
- Duncansville, Pennsylvania, United States
- Willow Grove, Pennsylvania, United States
- Memphis, Tennessee, United States
- Allen, Texas, United States
- Bellaire, Texas, United States
- Corpus Christi, Texas, United States
- Southport, Queensland, Australia
- Nedlands, Western Australia, Australia
- Rimouski, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Trois-Rivières, Quebec, Canada
- Hefei, Anhui, China
- Nanjing, Jiangsu, China
- Taiyuan, Shanxi, China
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Avondale, Arizona, United States; Clearwater, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Willowbrook, Illinois, United States; Oklahoma City, Oklahoma, United States and 24 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.