Only 142 spots left

~142 spots leftby Jun 2026

HZN-1116 for Sjogren's Syndrome

Recruiting in Palo Alto (17 mi)

+80 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Amgen

Must not be taking: Biologics, B cell therapies

Disqualifiers: System sclerosis, Active malignancy, Pregnancy, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have taken experimental biologic or oral agents recently, you may need to wait before joining the study.

Research Team

Principal Investigator

Amgen

Eligibility Criteria

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.

Inclusion Criteria

My ESSDAI score is 5 or higher.

My ESSDAI score is below 5.

Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification Criteria

See 2 more

Exclusion Criteria

I haven't had B cell-depleting or targeting therapy, or anti-type I IFN pathway therapy in the last 6-12 months.

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

I have systemic sclerosis.

See 5 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment

Participants receive subcutaneous (SC) dose of HZN-1116 or placebo for 48 weeks

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

HZN-1116 (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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