Last updated 3 days ago
A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
344 patients around the world
Available in Colombia, United States
This study is a Phase 2a/b, randomized, double-blind, placebo-controlled, multi-center trial involving participants with SjD. The study consists of three parts (Part A, Part B, and Part C).
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.
Novartis Pharmaceuticals
344Patients around the world
This study is for people with
Rare diseases
Sjogren's syndrome
Requirements for the patient
To 100 Years
All Gender
Medical requirements
- 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.
- 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.
SponsorNovartis Pharmaceuticals
Study typeInterventional
Conditions
Sjogren's syndrome
Requirements
To 100 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07737743
