HZN-1116 for Sjogren's Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of a new treatment called HZN-1116 for people with Sjogren's syndrome, a condition where the immune system mistakenly attacks moisture-producing glands, causing dry eyes and mouth. The study compares different doses of HZN-1116 and a placebo (a treatment with no active drug) to evaluate their effectiveness and safety. People diagnosed with Sjogren's syndrome who test positive for certain antibodies might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in Sjogren's syndrome treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that HZN-1116 is under study for its safety and effectiveness in treating Sjogren's syndrome. Patients have generally tolerated the treatment well, with no major reports of severe side effects. However, like any medication, some participants might experience mild side effects, such as minor headaches or nausea. The study currently focuses on finding the best dose and identifying common side effects, with safety closely monitored. Early results suggest that HZN-1116 could be a safe option for people with Sjogren's syndrome, but more research is needed to confirm this.12345
Why do researchers think this study treatment might be promising for Sjogren's syndrome?
Researchers are excited about HZN-1116 for Sjogren's Syndrome because it offers a fresh approach compared to existing treatments like artificial tears, pilocarpine, and cevimeline, which mainly focus on symptomatic relief. Unlike these standard options, HZN-1116 is designed to target the underlying immune dysfunction associated with Sjogren's Syndrome. This new mechanism of action could potentially modify the disease process itself, rather than just alleviating symptoms. By directly addressing the root cause, HZN-1116 has the potential to significantly improve patient outcomes and quality of life.
What evidence suggests that HZN-1116 might be an effective treatment for Sjogren's syndrome?
Research shows that HZN-1116 is undergoing testing as a potential treatment for Sjogren's syndrome, an autoimmune disease. The trial includes various treatment arms, with participants receiving different doses of HZN-1116 or a placebo. This drug targets CD40, a protein involved in the immune system. Early results suggest that HZN-1116 might reduce inflammation and improve symptoms in people with Sjogren's syndrome. Although detailed results are not yet available, this approach offers hope for its effectiveness. The ongoing studies aim to determine a safe dose and assess its efficacy for those with this condition.23678
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous (SC) dose of HZN-1116 or placebo for 48 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HZN-1116
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
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