A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

Key Inclusion Criteria:

1. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria

2. Have an ESSPRI score of ≥ 5 at screening.

3. Have an ESSDAI score of < 5 at screening.

4. Positive for either anti-Ro autoantibodies or RF, or both at screening (as per thedefinition of the standard central laboratory test).

5. Residual salivary gland function as defined by whole stimulated salivary flow > 0.1mL/min.

6. Vaccinated against SARS-CoV-2 according to current local authority guidelines atleast 2 weeks prior to screening unless participant refuses vaccination.

7. Meets all of the following tuberculosis (TB) criteria:

8. No history of latent or active TB prior to screening, except for latent TB withdocumented completion of locally appropriate treatment.

9. No signs or symptoms suggestive of active TB from medical history or physicalexamination.

10. No recent (≤ 12 weeks of screening) close contact with a person with active TB (close contact is defined as ≥ 4 hours/week OR living in the same household ORin a house where a person with active TB is a frequent visitor).

11. Negative Interferon Gamma Release Assay (IGRA) test result for TB at screenunless previously treated as per Inclusion Criterion. Participants with anindeterminate test result can repeat the test, but if the repeat test is alsoindeterminate, they are excluded.

12. A chest radiograph (obtained during the screening period or any time within 12weeks prior to screening) with no evidence of current active TB or otherinfection, or prior TB, malignancy, or clinically significant abnormalitiessuggesting an active process (unless due to SS).

Key Exclusion Criteria:

1. Individuals with medical history of confirmed deep venous thrombosis, pulmonaryembolism, or arterial thromboembolism within 2 years of screening.

2. History or presence of concomitant polymyositis or dermatomyositis or systemicsclerosis.

3. Active malignancy or history of malignancy within the last 5 years, except asfollows:

4. In situ carcinoma of the cervix treated with apparent success with curativetherapy > 12 months prior to screening; OR

5. Cutaneous basal cell carcinoma following presumed curative therapy.

6. Individuals who are pregnant or lactating or planning to become pregnant during thestudy.

7. Individuals with known history of severe allergy or reaction to any component of theIP formulation or to any other biologic therapy.

8. Individuals with any severe cardiovascular, respiratory, endocrine,gastrointestinal, hematological, neurological, psychiatric, or systemic disorder orany other condition that, in the opinion of the Investigator, would place theindividual at unacceptable risk of complications, interfere with evaluation of theIP, or confound the interpretation of participant safety or study results.

9. Individuals who have a positive test for, or have been treated for, hepatitis B,hepatitis c or HIV infection.

10. Individuals with a positive test for SARS-CoV-2 on the day of randomization orsymptoms suggestive of SARS-CoV-2 at randomization or significant exposure tocoronavirus disease 2019 (COVID-19) within 10 calendar days prior to randomization.

11. Individuals with:

12. A history of more than one episode of herpes zoster and/or opportunisticinfections in the last 12 months, with the exception of non-invasive herpessimplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungalinfections, which are permitted within the prior 12 months unless of unusualseverity.

13. Active infection requiring systemic treatment at the time of screening orthrough randomization, or history of more than 2 infections requiring IVantibiotics within 12 months prior to screening.