Phase 2: testing DDY391 for Sjögren's Disease
To evaluate how well it works, 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.
Official registry: https://clinicaltrials.gov/study/NCT07737743 · Novartis Pharmaceuticals · enrollment listed as 344
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are DDY391, or Placebo. The registry lists allocation as randomized. To evaluate how well it works, 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.
They plan to enroll about 344 people at 30 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: DDY391, Placebo
Primary outcome (registry wording): Part A and B: Change from baseline in ESSDAI score
Who it is for (from inclusion criteria)
- Ages 18 Years to 100 Years
- 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
Who the registry excludes
- 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
- 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/
Public study contact (from the registry)
Novartis Pharmaceuticals
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
30 listed- Arizona Arthritis and Rheumatology Associates PLLC — Avondale, Arizona (recruiting)
- Clinical Res Of W Florida — Clearwater, Florida (recruiting)
- Clinical Research of West Florida Inc — Tampa, Florida (recruiting)
- Chicago Clinical Research Inst — Chicago, Illinois (recruiting)
- Willow Rheumatology Wellness — Willowbrook, Illinois (recruiting)
- RAO Research LLC — Oklahoma City, Oklahoma (recruiting)
- Altoona Center for Clin Res — Duncansville, Pennsylvania (recruiting)
- Rheumatology Specialty Center - Willow Grove Office — Willow Grove, Pennsylvania (recruiting)
- Shelby Research LLC — Memphis, Tennessee (recruiting)
- Stryde Research-Allen Arthritis — Allen, Texas (recruiting)
- Novel Research LLC — Bellaire, Texas (recruiting)
- Arthritis Care of Texas — Corpus Christi, Texas (recruiting)
+ 18 sites outside the US on the same record
FAQ about this NCT record
Is NCT07737743 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07737743?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07737743?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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