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NCT07737743PHASE2Recruiting

A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease

Novartis Pharmaceuticals

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

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.

Interventions

DRUG

DDY391

DRUG

Placebo

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Conditions

Sjögren's Disease

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