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HZN-825 for Systemic Sclerosis
Study Summary
This trial is testing a new drug to see if it is safe and effective for people with Huntington's disease. The trial will last for 52 weeks and will include people who take the drug and people who take a placebo.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
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- I haven't taken strong immune-suppressing drugs, except for allowed ones at low doses, in the last 4 weeks.I haven't had cancer in the past 5 years, except for certain skin or cervical cancers.I agree to use effective birth control during and for 1 month after the trial.I have PAH and need multiple oral treatments or any injection treatment.I have an autoimmune disease, but it's not fibromyalgia, scleroderma-associated myopathy, or secondary Sjogren's syndrome.I haven't taken corticosteroids for non-SSc conditions in the last 4 weeks, except for skin, inhalation, or joint treatments.My blood test is positive for anti-centromere antibodies.I was diagnosed with scleroderma renal crisis less than 6 months ago.I have had serious heart issues or very high or low blood pressure in the last 6 months.I do not have any active infections, except for fungal nail infections.I haven't used any FDA-approved or investigational drugs for scleroderma or any condition in the last 90 days or 5 half-lives, whichever is longer.You have a recent history of drug or alcohol abuse within the past 2 years.I have a liver condition related to alcohol, biliary cirrhosis, or sclerosing cholangitis.I have had an organ or bone marrow transplant.My lung function test shows less than 40% of what's expected.I have thickened skin on my forearm that can be biopsied again.My lung function test shows I can breathe well enough.The investigator believes that you have a medical condition that would make it unsafe for you to participate in the trial.My skin condition affects areas above my elbows and knees.I have been diagnosed with a type of scleroderma.I am between 18 and 75 years old.It's been less than 3 years since my first symptom of scleroderma, not counting Raynaud's.
- Group 1: HZN-825 300 mg once daily (QD)
- Group 2: HZN-825 300 mg twice daily (BID)
- Group 3: Placebo
- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 52 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 4 Weeks after you stop receiving the treatment.
Frequently Asked Questions
Is there an opportunity for me to participate in this clinical trial?
"This trial is open to scleroderma patients aged between 18 and 75. This experiment requires the participation of 300 applicants in total."
Is this research actively seeking participants at present?
"Yes, the latest data exhibited on clinicaltrials.gov demonstrate that this medical study is actively recruiting volunteers. This trial was first made available to potential participants on April 1st 2021 and has been recently updated on November 22nd 2022. 300 patients are required at 17 different sites for successful completion of the experiment."
What are the associated risks with consuming HZN-825 QD?
"Our team at Power evaluated the safety of HZN-825 QD to be a 2 on our scale due to its Phase 2 classification, i.e., there has been some evidence of security but no proof for effectiveness."
Is eligibility for the trial limited to those under 60 years of age?
"The age criterion for this study is 18-75, with 46 trials available to those under the legal age and 374 studies open to those over the senior threshold."
How many healthcare facilities are hosting this clinical trial?
"Numerous medical establishments are participating in this trial, including Perelman Center for Advanced Medicine (Philadelphia), Duke University Medical Center (Durham) and University of Miami Miller School of Medicine (Miami). There exists an additional 14 sites."
What is the maximum capacity for participants in this research?
"To commence the trial, 300 qualified participants are needed. Horizon Therapeutics Ireland DAC will be managing this study from several locations including Perelman Center for Advanced Medicine in Philadelphia, Pennsylvania and Duke University Medical Centre in Durham, North carolina."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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