A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome

Key Inclusion Criteria:

• Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULARClassification Criteria.

• Have an ESSDAI score of >= 5 at screening (only for Population 1).

• Have an ESSPRI score of >= 5 at screening (only for Population 2).

• Have an ESSDAI score of < 5 at screening (only for Population 2).

• Positive for anti-Ro autoantibodies, rheumatoid factor (RF) at screening, or both atscreening.

Key Exclusion Criteria:

• Concomitant system sclerosis.

• Active malignancy or history of malignancy within the last 5 years with exception ofin situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening; OR cutaneous basal cell carcinoma following presumedcurative therapy.

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

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

• Individuals with history of more than one episode of herpes zoster and/oropportunistic infections in the last 12 months, with the exception of non-invasiveherpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneousfungal infections, which are permitted within the prior 12 months unless of unusualseverity. Individuals with a prior history of ophthalmic herpes zoster will beexcluded.

• Active infections requiring systemic treatment at the time of screening or throughrandomization, or history of more than 2 infections requiring intravenous (IV)antibiotics within 12 months prior to screening.

• Last administration of experimental biologic or oral agents < 6 months or 5half-lives, whichever is longer, before screening.

• Individuals who have had previous treatment with any biologic B cell-depletingtherapy (eg, rituximab, ocrelizumab, inebilizumab, or ofatumumab) within 12 monthsor other B cell targeting therapy (eg, belimumab) or anti-type I IFN pathway therapy (eg, anifrolumab) < 6 months before randomization.