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Monoclonal Antibodies

HZN-1116 for Sjogren's Syndrome

Phase 2
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Positive for anti-Ro autoantibodies, rheumatoid factor (RF) at screening, or both at screening
Be older than 18 years old
Must not have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 24 and week 48
Awards & highlights

Summary

This trial aims to determine how well and how safe HZN-1116 is for people with Sjogren's syndrome.

Who is the study for?
This trial is for individuals with Sjogren's Syndrome, a condition that causes dry eyes and mouth. Participants must meet specific criteria like having certain scores on disease activity and symptom scales (ESSDAI >=5 for Population 1; ESSPRI >=5 and ESSDAI <5 for Population 2) and testing positive for particular autoantibodies or rheumatoid factor.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of HZN-1116 compared to a placebo in treating symptoms of Sjogren's Syndrome. It aims to see if HZN-1116 can improve patients' conditions better than an inactive substance.See study design
What are the potential side effects?
While the side effects of HZN-1116 are not detailed here, common side effects in trials may include reactions at the injection site, headaches, fatigue, nausea, or other immune-related responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I tested positive for anti-Ro autoantibodies or rheumatoid factor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had B cell-depleting or targeting therapy, or anti-type I IFN pathway therapy in the last 6-12 months.
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I do not have current infections needing treatment or a history of frequent severe infections.
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I have tested positive or been treated for hepatitis B, C, or HIV.
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I have systemic sclerosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 24 and week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 24 and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2)
Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1)
Secondary outcome measures
Change from baseline in 36-item Short Form Survey (SF-36) mental component score (MCS) (Population #1)
Change from baseline in 36-item Short Form Survey (SF-36) mental component score MCS (Population #2)
Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) (Population #1)
+20 more

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: HZN-1116 Dose 4 in Population 2Experimental Treatment1 Intervention
Participants will receive Dose 4 of HZN-1116
Group II: HZN-1116 Dose 3 in Population 2Experimental Treatment1 Intervention
Participants will receive Dose 3 of HZN-1116
Group III: HZN-1116 Dose 2 in Population 2Experimental Treatment1 Intervention
Participants will receive Dose 2 of HZN-1116
Group IV: HZN-1116 Dose 2 in Population 1Experimental Treatment1 Intervention
Participants will receive Dose 2 of HZN-1116
Group V: HZN-1116 Dose 1 in Population 2Experimental Treatment1 Intervention
Participants will receive Dose 1 of HZN-1116
Group VI: HZN-1116 Dose 1 in Population 1Experimental Treatment1 Intervention
Participants will receive Dose 1 of HZN-1116
Group VII: Placebo in Population 1Placebo Group1 Intervention
Participants will receive Placebo matched to HZN-1116
Group VIII: Placebo in Population 2Placebo Group1 Intervention
Participants will receive Placebo matched to HZN-1116

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,392 Previous Clinical Trials
1,380,858 Total Patients Enrolled
3 Trials studying Sjogren's Syndrome
650 Patients Enrolled for Sjogren's Syndrome
Horizon Therapeutics Ireland DACLead Sponsor
20 Previous Clinical Trials
2,214 Total Patients Enrolled
1 Trials studying Sjogren's Syndrome
510 Patients Enrolled for Sjogren's Syndrome
MDStudy DirectorAmgen
937 Previous Clinical Trials
927,005 Total Patients Enrolled
3 Trials studying Sjogren's Syndrome
1,128 Patients Enrolled for Sjogren's Syndrome
~175 spots leftby Sep 2026