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Other

HZN-825 for Systemic Sclerosis

Phase 2
Recruiting
Research Sponsored by Horizon Therapeutics Ireland DAC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female between the ages of 18 and 75 years, inclusive, at Screening.
Classified as having skin involvement proximal to the elbow and knee (diffuse cutaneous SSc subset by LeRoy and Medsger, 2001).
Must not have
Positive for anti-centromere antibodies.
Diagnosed with sine scleroderma or limited cutaneous SSc.
Timeline
Screening 2 weeks
Treatment 52 weeks
Follow Up 4 weeks

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.

Who is the study for?
This trial is for adults aged 18-75 with diffuse cutaneous systemic sclerosis, a skin condition causing thickening and hardening. Participants must have certain severity scores, no recent severe heart issues or organ transplants, stable medication use if applicable, and agree to birth control measures. Those with specific infections or other autoimmune diseases are excluded.
What is being tested?
The study tests HZN-825 taken once (QD) or twice daily (BID) against a placebo over 52 weeks to assess its effectiveness in treating systemic sclerosis. It's randomized and double-blind, meaning neither the participants nor the researchers know who receives the actual drug versus placebo.
What are the potential side effects?
While not specified here, potential side effects of drugs like HZN-825 could include gastrointestinal discomfort, skin reactions at the site of application or biopsy, fatigue due to immune system modulation, and possible abnormal liver function tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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My skin condition affects areas above my elbows and knees.
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I have thickened skin on my forearm that can be biopsied again.
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My lung function test shows I can breathe well enough.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood test is positive for anti-centromere antibodies.
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I have been diagnosed with a type of scleroderma.
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I have an autoimmune disease, but it's not fibromyalgia, scleroderma-associated myopathy, or secondary Sjogren's syndrome.
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I have had serious heart issues or very high or low blood pressure in the last 6 months.
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I do not have any active infections, except for fungal nail infections.
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I agree to use effective birth control during and for 1 month after the trial.
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I have a liver condition related to alcohol, biliary cirrhosis, or sclerosing cholangitis.
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I have had an organ or bone marrow transplant.

Timeline

Screening ~ 2 weeks
Treatment ~ 52 weeks
Follow Up ~4 weeks
This trial's timeline: 2 weeks for screening, 52 weeks for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in FVC (forced vital capacity) percent predicted from Baseline to Week 52
Secondary study objectives
Change from Baseline in HAQ-DI (Health Assessment Questionnaire - Disability Index) at Week 52
Change from Baseline in MDGA (Physician Global Assessment) at Week 52
Change from Baseline in PTGA (Patient Global Assessment) at Week 52
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: HZN-825 300 mg twice daily (BID)Experimental Treatment1 Intervention
One set of 2 HZN-825 150mg tablets in the morning and one set of 2 HZN-825 150mg tablets in the evening.
Group II: HZN-825 300 mg once daily (QD)Experimental Treatment1 Intervention
One set of 2 HZN-825 150mg tablets in the morning and one set of 2 placebo tablets in the evening.
Group III: PlaceboPlacebo Group1 Intervention
One set of 2 placebo tablets in the morning and one set of 2 placebo tablets in the evening.

Find a Location

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?

Horizon Therapeutics Ireland DACLead Sponsor
20 Previous Clinical Trials
2,092 Total Patients Enrolled
Medical DirectorStudy DirectorHorizon Therapeutics
2,882 Previous Clinical Trials
8,088,846 Total Patients Enrolled
Farah Ali, MDStudy DirectorHorizon Therapeutics
1 Previous Clinical Trials
153 Total Patients Enrolled

Media Library

HZN-825 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04781543 — Phase 2
Systemic Sclerosis Research Study Groups: HZN-825 300 mg once daily (QD), HZN-825 300 mg twice daily (BID), Placebo
Systemic Sclerosis Clinical Trial 2023: HZN-825 Highlights & Side Effects. Trial Name: NCT04781543 — Phase 2
HZN-825 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04781543 — Phase 2
~36 spots leftby Jun 2025
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