A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
Start Date
8/24/2026
Completion Date
3/19/2029
Summary
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.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to 100 years
Interventions
DDY391
Placebo
Conditions
Locations
Clinical Res Of W Florida
Clearwater, Florida 33765
United States
Clinical Research of West Florida Inc
Tampa, Florida 33603
United States
Chicago Clinical Research Inst
Chicago, Illinois 60607
United States
Willow Rheumatology Wellness
Willowbrook, Illinois 60527
United States
RAO Research LLC
Oklahoma City, Oklahoma 73116
United States
Altoona Center for Clin Res
Duncansville, Pennsylvania 16635
United States
Stryde Research-Allen Arthritis
Allen, Texas 75013
United States
Novel Research LLC
Bellaire, Texas 77401
United States
Arthritis Care of Texas
Corpus Christi, Texas 78415
United States
Novartis Investigative Site
Southport, Queensland 4222
Australia
Novartis Investigative Site
Nedlands, Western Australia 6009
Australia
Novartis Investigative Site
Rimouski, Quebec G5L 5T1
Canada
Novartis Investigative Site
Sherbrooke, Quebec J1G 2E8
Canada
Novartis Investigative Site
Trois-Rivières, Quebec G9A 3Y2
Canada
Novartis Investigative Site
Taiyuan, Shanxi 030000
China
Novartis Investigative Site
Beijing, 100034
China
Novartis Investigative Site
Beijing, 100050
China
Novartis Investigative Site
Kfar Saba, 4428164
Israel
Novartis Investigative Site
Petah Tikva, 4941492
Israel
Novartis Investigative Site
Ramat Gan, 5265601
Israel
Novartis Investigative Site
Tel Aviv, 6423906
Israel
Novartis Investigative Site
Ẕerifin, 7030000
Israel