Recruiting
Phase 2

DDY391

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07737743

Conditions

Sjögren's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

DDY391

Placebo

Study Details

Brief 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.

Conditions

Sjögren's Disease

Study ID

NCT07737743

Start date

Aug 24, 2026

Status verified date

Oct, 2026

Completion date

Mar 19, 2029

Anticipated

Primary completion date

Feb 19, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

344 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A- DDY391 dose level 1

DDY391 dose level 1

experimental: Part A-Placebo

Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.

experimental: Part B- DDY391 dose level 1

DDY391 dose level 1

experimental: Part B- DDY391 dose level 2

DDY391 dose level 2

experimental: Part B- DDY391 dose level 3

DDY391 dose level 3

experimental: Part B- Placebo

Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.

experimental: Part C- DDY391 dose level 1

DDY391 dose level 1

experimental: Part C- Placebo

Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.

Interventions

DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3

Placebo

Matching Placebo

Primary outcome measure

  • Part A and B: Change from baseline in ESSDAI score [ Time Frame: Baseline, Week 24 ]
  • Part C: Change from baseline in ESSPRI [ Time Frame: Baseline, Week 24 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Clinical Res Of W Florida

Recruiting

Clearwater, Florida, United States, 33765

Contacts

Jessica Mayfield

+1 727 466 0078JMayfield@crwf.com

Principal Investigator:

Rodney Daniel

Clinical Research of West Florida Inc

Recruiting

Tampa, Florida, United States, 33603

Contacts

Sydney K Mullen

+1 813 870 1292smullen@crwf.com

Principal Investigator:

John Carter

Chicago Clinical Research Inst

Recruiting

Chicago, Illinois, United States, 60607

Contacts

Saad Hussaini Syed

ssyed@ccrii.us

Principal Investigator:

Dennis Levinson

Willow Rheumatology Wellness

Recruiting

Willowbrook, Illinois, United States, 60527

Contacts

Avni Singh

asingh@willowrheum.com

Principal Investigator:

Angela R Crowley

RAO Research LLC

Recruiting

Oklahoma City, Oklahoma, United States, 73116

Contacts

Erica Beer

+1 405 608 8060ebeer@raoklahoma.com

Principal Investigator:

Latisha Heinlen

Altoona Center for Clin Res

Recruiting

Duncansville, Pennsylvania, United States, 16635

Contacts

Nicole Barnhill

nbarnhill@altoonaresearch.com

Principal Investigator:

Alan J Kivitz

Stryde Research-Allen Arthritis

Recruiting

Allen, Texas, United States, 75013

Contacts

Aarsheya Amin

+1 972 747 0709aamin@stryderesearch.com

Principal Investigator:

John Lavery

Novel Research LLC

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Hassan Khan

+1 281 944 3610khan@novelresearch.net

Principal Investigator:

Wajeeha Yousaf

Arthritis Care of Texas

Recruiting

Corpus Christi, Texas, United States, 78415

Contacts

Tatum Trevino

+1 361 400 7700tatum.trevino@sclamanagement.com

Principal Investigator:

Eric Ping Chiang

Novartis Investigative Site

Recruiting

Rimouski, Quebec, Canada, G5L 5T1

Novartis Investigative Site

Recruiting

Sherbrooke, Quebec, Canada, J1G 2E8

Novartis Investigative Site

Recruiting

Trois-Rivières, Quebec, Canada, G9A 3Y2

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Sjögren's Disease
  • ESSDAI
  • ESSPRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.