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Monoclonal Antibodies

HZN-1116 Dose 2 in Population 1 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 24 and week 48
Awards & highlights

Study 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
Select...
I tested positive for anti-Ro autoantibodies or rheumatoid factor.

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
1,382 Previous Clinical Trials
1,379,421 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
928 Previous Clinical Trials
926,468 Total Patients Enrolled
3 Trials studying Sjogren's Syndrome
1,128 Patients Enrolled for Sjogren's Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current total number of participants being recruited for this clinical study?

"Affirmative, the information available on clinicaltrials.gov indicates that this medical study is actively seeking participants. This trial was initially posted on April 9th, 2024 and its most recent update occurred on April 26th, 2024. The research aims to recruit a total of 262 patients from three designated locations."

Answered by AI

Is the enrollment process open for this medical study at present?

"Yes, information from clinicaltrials.gov indicates that this trial is currently enrolling participants. The trial was first posted on April 9th, 2024 and last updated on April 26th, 2024. It aims to recruit 262 patients across three designated sites."

Answered by AI

Does this study allow participants who are older than 70 years of age?

"For enrollment in this clinical trial, individuals must be at least 18 years old but no older than 75."

Answered by AI

What is the potential harm of administering HZN-1116 Dose 2 to individuals in Population 1?

"Based on our evaluation, the safety rating for HZN-1116 Dose 2 among Population 1 is scored at 2 by our team. This assessment is influenced by the absence of efficacy data despite some evidence supporting its safety in this Phase 2 trial."

Answered by AI

Who else is applying?

What site did they apply to?
DJL Clinical Research PLLC
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I weasnt help for my dry mouth.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome
2024. "A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06312020.
All > High Point > Greensboro
~175 spots leftby Sep 2026
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