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

July 27, 2026 updated by: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2a/b Study Assessing the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

344

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A- DDY391 dose level 1
DDY391 dose level 1
Drug: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
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.
Drug: Placebo
Matching Placebo
Drug: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Experimental: Part B- DDY391 dose level 1
DDY391 dose level 1
Drug: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Experimental: Part B- DDY391 dose level 2
DDY391 dose level 2
Drug: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Experimental: Part B- DDY391 dose level 3
DDY391 dose level 3
Drug: DDY391

DDY391 dose level 1

DDY391 dose level 2

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.
Drug: Placebo
Matching Placebo
Drug: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Experimental: Part C- DDY391 dose level 1
DDY391 dose level 1
Drug: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
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.
Drug: Placebo
Matching Placebo
Drug: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A and B: Change from baseline in ESSDAI score
Time Frame: Baseline, Week 24
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
Time Frame: Baseline, Week 24
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A and B: Change from baseline in ESSPRI
Time Frame: Baseline, Week 24
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
Part A, B and C: Change from baseline in SSSD
Time Frame: Baseline, Week 24
Sjögren's Syndrome Symptom Diary (SSSD) includes six items specific to SjD (eye dryness, mouth dryness skin dryness, tiredness, muscle and/or joint pain, and genital dryness). The total score ranges from 0 (no symptoms) to 10 (maximal symptom severity).
Baseline, Week 24
Part A, B and C: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to Week 52
To evaluate the safety and tolerability of multiple doses of DDY391.
Baseline up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 27, 2026

Primary Completion (Estimated)

February 19, 2029

Study Completion (Estimated)

March 19, 2029

Study Registration Dates

First Submitted

July 27, 2026

First Submitted That Met QC Criteria

July 27, 2026

First Posted (Actual)

July 30, 2026

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDDY391B12201
  • 2025-524513-92-00 (Other Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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