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

ClinicalTrials.gov identifier NCT07737743

Novartis reference CDDY391B12201

Show study information as

Info The simplified version is generated by AI to make the study easier to understand. It may contain mistakes or leave out details. The original information is the official description of the study.
Condition
Condition Sjögren's Disease
Status
Study status Recruiting
Phase
Phase 2
Participants
Number of participants 344
Gender
Gender All
Age
Age 18 to 100 years
Learn More

Study details

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.

Interventions

DRUG: DDY391|DRUG: Placebo

Official title

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

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Last update:Nov. 3, 2026, 4:55 a.m.

Who can take part?

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.

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.

  1. Home
  2. Clinical trials
  3. NCT07737743

Study of an Investigational Treatment for Sjögren’s Disease

ClinicalTrials.gov identifier NCT07737743

Novartis reference CDDY391B12201

Show study information as

Info The simplified version is generated by AI to make the study easier to understand. It may contain mistakes or leave out details. The original information is the official description of the study.
Condition
Condition Sjögren's Disease
Status
Study status Recruiting
Phase
Phase 2
Participants
Number of participants 344
Gender
Gender All
Age
Age 18 to 100 years
Learn More

Study details

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

The purpose of this research study is to learn about the effects and safety of an investigational treatment in people with Sjögren’s disease.

Participants will receive either the investigational treatment or a placebo. A placebo looks like the investigational treatment but does not contain active medication. Participants will be in the treatment part of the study for 52 weeks, and then will have a 4-week safety follow-up after the last dose.

This study may be an option for
People with Sjögren’s disease may be able to participate if they:

  • Have Sjögren’s disease based on the ACR/EULAR 2016 classification criteria
  • Have a positive anti-Ro (SSA) antibody test at screening, or (if anti-Ro/SSA is negative) have records of a past salivary gland biopsy showing inflammation consistent with Sjögren’s disease

 

Study timeline and visits:
There is a screening period of up to 8 weeks. Treatment lasts 52 weeks. After the last dose, there is a 4-week safety follow-up period.

Interventions

DRUG: DDY391|DRUG: Placebo

Official title

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

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Last update:Nov. 3, 2026, 4:55 a.m.

Who can take part?

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

You might be able to join if

  • Have a diagnosis of Sjögren’s disease based on the ACR/EULAR 2016 classification criteria at screening
  • Have a positive anti-Ro (SSA) antibody test at screening, or (if anti-Ro/SSA is negative) have medical records showing a past salivary gland biopsy with inflammation consistent with Sjögren’s disease

You might not be able to join if

  • Have another autoimmune rheumatic disease that is active at screening and is the main illness
  • Be taking more than 400 mg per day of hydroxychloroquine for Sjögren’s disease
  • Have taken any of the following within 3 months before randomization: belimumab, abatacept, anti-tumor necrosis factor alpha biologic agents, immunoglobulins, plasmapheresis, intravenous or oral cyclophosphamide, mycophenolate mofetil, intravenous or oral cyclosporine A, or other immunosuppressants (for example, JAK inhibitors or other kinase inhibitors, IL-2, anti-IL-6, anti-IL-17)
  • Have previously received any cell-depleting therapy (including anti-CD20) unless it was at least 12 months before screening
  • Have any viral, bacterial, or other infection at screening or randomization, or a history of recurrent clinically significant infection or recurrent bacterial infection
  • Have had cancer in any organ system within the last 5 years before randomization (except localized non-melanoma skin cancer or cervical cancer in situ), or have any cancer that is not in remission

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