Sjogren's Syndrome
Conditions
Keywords
SS, Sjogren's, HZN-1116, Autoimmune disease, Dry Eye syndrome, VIB1116
Brief summary
The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).
Detailed description
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.
Interventions
DRUGHZN-1116
Subcutaneous Administration
DRUGPlacebo
Subcutaneous Administration
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1) | At Week 48 |
| Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2) | At Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in PROMIS-Fatigue SF-10a (Population #2) | At Week 24 |
| Serum concentration of HZN-1116 starting at Week 1 through study completion (Population #1 and #2) | Up to Week 60 |
| Proportion of Participants who develop anti drug antibodies (ADA) over time (Population #1 and #2) | Up to Week 60 |
| Change from baseline in ESSDAI (Population #1) | At Week 24 |
| Proportion of Participants achieving ESSDAI [5] response (Population #1) | At Week 24 and Week 48 |
| Change from baseline in ESSPRI pain domain score (Population #1) | At Week 24 and Week 48 |
| Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) pain domain score (Population #1) | At Week 24 and Week 48 |
| Change from baseline in ESSPRI fatigue domain score (Population #1) | At Week 24 and Week 48 |
| Change from baseline in DASPRI fatigue domain score (Population #1) | At Week 24 and Week 48 |
| Change from baseline in ESSPRI dryness domain score (Population #1) | At Week 24 and Week 48 |
| Change from baseline in DASSPRI dryness domain score (Population #1) | At Week 24 and Week 48 |
| Change from baseline in tender joint count (TJC) (Population #1) | At Week 24 and Week 48 |
| Change from baseline in swollen joint count (SJC) (Population #1) | At Week 24 and Week 48 |
| Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) (Population #1) | At Week 24 and Week 48 |
| Change from baseline in 36-item Short Form Survey (SF-36) mental component score (MCS) (Population #1) | At Week 24 and Week 48 |
| Change from baseline in patient-reported outcomes measurement information system (PROMIS)-Fatigue SF-10a (Population #1) | At Week 24 and Week 48 |
| Change from baseline in DASPRI (Population #2) | At Week 24 |
| Proportion of Participants achieving ESSPRI [1.5] response (Population #2) | At Week 24 |
| Change from baseline in ESSPRI pain domain (Population #2) | At Week 24 |
| Change from baseline in ESSPRI fatigue domain (Population #2) | At Week 24 |
| Change from baseline in SF-36 PCS Score (Population #2) | At Week 24 |
| Change from baseline in ESSPRI dryness domain (Population #2) | At Week 24 |
| Change from baseline in 36-item Short Form Survey (SF-36) mental component score MCS (Population #2) | At Week 24 |
Countries
Argentina, Austria, Chile, Colombia, France, Germany, Hungary, Italy, Mexico, Poland, Portugal, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed