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

Launched by AMGEN · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called HZN-1116 for people with Sjogren's syndrome, a condition that affects moisture-producing glands and can cause dry mouth and eyes, among other symptoms. The main goal of the study is to see how effective and safe this treatment is for participants diagnosed with Sjogren's syndrome. The trial is currently recruiting participants aged 18 and older who meet specific criteria, such as having positive test results for certain autoantibodies and a specific score measuring their disease activity.

If you or a loved one qualifies for this study, you can expect to receive either the new treatment or a placebo (a harmless substance) while being closely monitored by healthcare professionals. It’s important to note that certain individuals, such as those with certain infections, recent cancer history, or those who are pregnant, will not be eligible to participate. This trial could provide valuable information about a potential new option for managing Sjogren's syndrome.

Gender

ALL

Eligibility criteria

• 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.