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

NCT07737743 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CDDY391B122012025-524513-92-00
• Study Type: interventional
• Target: 344
• Locations: 0 countries
• Sites: N/A

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

Keywords

Sjögren's Disease; ESSDAI; ESSPRI

Outcome Measures

Primary Outcomes (2)

• Part A and B: Change from baseline in ESSDAI score

  EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a validated tool for assessing disease activity in SjD. Score range is 0-123. Higher scores on the ESSDAI scale are associated with poorer health states. A negative change from baseline indicates improvement in disease status.

  Baseline, Week 24

• Part C: Change from baseline in ESSPRI

  EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a validated disease outcome measure for SjD. It consists of three domains of dryness, pain, and fatigue. The participant will assess severity of symptoms they experienced over the last 14 days on a single 0-10 numerical rating scale for each of the three domains. The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain + fatigue) /3. The total ESSPRI score ranges from 0 (no symptoms) to 10 (maximal symptom severity).

  Baseline, Week 24

Secondary Outcomes (3)

• Part A and B: Change from baseline in ESSPRI

  Baseline, Week 24

• Part A, B and C: Change from baseline in SSSD

  Baseline, Week 24

• Part A, B and C: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to Week 52

Study Arms (8)

Part A- DDY391 dose level 1

EXPERIMENTAL

DDY391 dose level 1

Drug: DDY391

Part A-Placebo

EXPERIMENTAL

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

Drug: DDY391; Drug: Placebo

Part B- DDY391 dose level 1

EXPERIMENTAL

DDY391 dose level 1

Drug: DDY391

Part B- DDY391 dose level 2

EXPERIMENTAL

DDY391 dose level 2

Drug: DDY391

Part B- DDY391 dose level 3

EXPERIMENTAL

DDY391 dose level 3

Drug: DDY391

Part B- Placebo

EXPERIMENTAL

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

Drug: DDY391; Drug: Placebo

Part C- DDY391 dose level 1

EXPERIMENTAL

DDY391 dose level 1

Drug: DDY391

Part C- Placebo

EXPERIMENTAL

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

Drug: DDY391; Drug: Placebo

Interventions

DDY391 DRUG

DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3

Part A- DDY391 dose level 1; Part A-Placebo; Part B- DDY391 dose level 1; Part B- DDY391 dose level 2; Part B- DDY391 dose level 3; Part B- Placebo; Part C- DDY391 dose level 1; Part C- Placebo

Placebo DRUG

Matching Placebo

Part A-Placebo; Part B- Placebo; Part C- Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of another autoimmune rheumatic disease that is active at screening and constitutes the principal illness.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

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

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 27, 2026
• Primary Completion (Estimated): February 19, 2029
• Study Completion (Estimated): March 19, 2029
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share