DDY391 in Sjögren's disease: see if it works and is safe

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2a/b randomized, double-blind, placebo-controlled, multicenter trial in adults with Sjögren's disease. Participants are assigned to DDY391 or placebo across three parts to explore dose response and determine dose selection for future trials. The study includes up to 8 weeks of screening, a 52-week treatment period, and 4 weeks of safety follow-up after the last dose. Key outcomes focus on efficacy, safety, and tolerability over the treatment period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Arizona Arthritis and Rheumatology Associates PLLC
  Avondale, Arizona, United States Recruiting
• Clinical Res Of W Florida
  Clearwater, Florida, United States Recruiting
• Clinical Research of West Florida Inc
  Tampa, Florida, United States Recruiting
• Chicago Clinical Research Inst
  Chicago, Illinois, United States Recruiting
• Willow Rheumatology Wellness
  Willowbrook, Illinois, United States Recruiting
• RAO Research LLC
  Oklahoma City, Oklahoma, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.