HZN-1116 for Sjogren's Syndrome

Recruiting at 93 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Amgen

Must not be taking: Biologics, B cell therapies

Disqualifiers: System sclerosis, Active malignancy, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

262 Participants Needed

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

MD

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

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.

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

Trial Overview 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.

Participant Groups

Group I: HZN-1116 Dose 4 in Population 2 Experimental Treatment 1 Intervention

Participants will receive Dose 4 of HZN-1116

Group II: HZN-1116 Dose 3 in Population 2 Experimental Treatment 1 Intervention

Participants will receive Dose 3 of HZN-1116

Group III: HZN-1116 Dose 2 in Population 2 Experimental Treatment 1 Intervention

Participants will receive Dose 2 of HZN-1116

Group IV: HZN-1116 Dose 2 in Population 1 Experimental Treatment 1 Intervention

Participants will receive Dose 2 of HZN-1116

Group V: HZN-1116 Dose 1 in Population 2 Experimental Treatment 1 Intervention

Participants will receive Dose 1 of HZN-1116

Group VI: HZN-1116 Dose 1 in Population 1 Experimental Treatment 1 Intervention

Participants will receive Dose 1 of HZN-1116

Group VII: Placebo in Population 1 Placebo Group 1 Intervention

Participants will receive Placebo matched to HZN-1116

Group VIII: Placebo in Population 2 Placebo Group 1 Intervention

Participants will receive Placebo matched to HZN-1116

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Horizon Therapeutics Ireland DAC

Lead Sponsor

Trials

21

Recruited

2,500+