Clinical Trial Finder

Key

Inclusion Criteria:

• - Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification 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 at screening.

Key

Exclusion Criteria:

• - Concomitant system sclerosis.

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

• - Individuals who are pregnant or lactating or planning to become pregnant during the study.

• - 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/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity.

Individuals with a prior history of ophthalmic herpes zoster will be excluded.

• - Active infections requiring systemic treatment at the time of screening or through randomization, 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 5 half-lives, whichever is longer, before screening.

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

The study will enroll 2 SS populations: Population 1 will include participants with moderate to high systemic disease activity; Population 2 will include participants with moderate to severe subjective symptoms. This study will include 3 periods: screening (5 weeks), treatment period (48 Weeks) and follow-up period (12 weeks). In the treatment period, participants from each of the populations will be randomized to receive subcutaneous (SC) dose of HZN-1116 or placebo. Acquired from Horizon in 2024.

Arms

Experimental: HZN-1116 Dose 1 in Population 1

Participants will receive Dose 1 of HZN-1116

Experimental: HZN-1116 Dose 2 in Population 1

Participants will receive Dose 2 of HZN-1116

Placebo Comparator: Placebo in Population 1

Participants will receive Placebo matched to HZN-1116

Experimental: HZN-1116 Dose 1 in Population 2

Participants will receive Dose 1 of HZN-1116

Experimental: HZN-1116 Dose 2 in Population 2

Participants will receive Dose 2 of HZN-1116

Experimental: HZN-1116 Dose 3 in Population 2

Participants will receive Dose 3 of HZN-1116

Experimental: HZN-1116 Dose 4 in Population 2

Participants will receive Dose 4 of HZN-1116

Placebo Comparator: Placebo in Population 2

Participants will receive Placebo matched to HZN-1116

Interventions

Drug: - HZN-1116

Subcutaneous Administration

Drug: - Placebo

Subcutaneous Administration