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

Novartis

Status and phase: Enrolling; Phase 2

Conditions: Sjögren's Disease

Treatments: Drug: Placebo; Drug: DDY391

Study type: Interventional

Funder types: Industry

Identifiers

NCT07737743

CDDY391B12201

2025-524513-92-00 (Other Identifier)

2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 344 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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344 participants in 8 patient groups

Part A- DDY391 dose level 1

Experimental group

Description:

DDY391 dose level 1

Treatment:

Drug: DDY391

Part A-Placebo

Experimental group

Description:

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

Treatment:

Drug: DDY391

Drug: Placebo

Part B- DDY391 dose level 1

Experimental group

Description:

DDY391 dose level 1

Treatment:

Drug: DDY391

Part B- DDY391 dose level 2

Experimental group

Description:

DDY391 dose level 2

Treatment:

Drug: DDY391

Part B- DDY391 dose level 3

Experimental group

Description:

DDY391 dose level 3

Treatment:

Drug: DDY391

Part B- Placebo

Experimental group

Description:

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

Treatment:

Drug: DDY391

Drug: Placebo

Part C- DDY391 dose level 1

Experimental group

Description:

DDY391 dose level 1

Treatment:

Drug: DDY391

Part C- Placebo

Experimental group

Description:

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

Treatment:

Drug: DDY391

Drug: Placebo