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Unknown

HZN-825 for Scleroderma

Phase 2
Waitlist Available
Research Sponsored by Horizon Pharma Ireland, Ltd., Dublin Ireland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to week 56
Awards & highlights

Study Summary

This trial will measure the safety and efficacy of a drug given to people with systemic sclerosis over a year.

Who is the study for?
This trial is for adults who've completed a previous HZNP-HZN-825-301 trial for diffuse cutaneous systemic sclerosis, even if they stopped early for non-safety reasons. It's not open to pregnant women, those at reproductive age not using birth control, or anyone with new risks that could make the trial unsafe.Check my eligibility
What is being tested?
The study tests HZN-825 over 52 weeks in patients with diffuse cutaneous systemic sclerosis. The focus is on lung function improvement (FVC %) and safety by monitoring adverse events up to four weeks after the last dose.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be closely monitored for any adverse reactions including serious ones and special interest events related to HZN-825 throughout the treatment period.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to week 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to week 56 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 HZN-825 Baseline, defined as the latest measurement prior to the first dose of HZN-825 in either trial HZNP-HZN-825-301 or this extension trial in FVC % predicted
Change from HZN-825 baseline in abnormal laboratory test results
Change from HZN-825 baseline in vital signs as reported as TEAEs
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: HZN-825Experimental Treatment1 Intervention
HZN-825 will be administered by mouth (PO) twice daily (BID) for 52 weeks

Find a Location

Who is running the clinical trial?

Horizon Pharma Ireland, Ltd., Dublin IrelandLead Sponsor
30 Previous Clinical Trials
3,567 Total Patients Enrolled
Medical DirectorStudy DirectorHorizon Therapeutics
2,769 Previous Clinical Trials
8,061,954 Total Patients Enrolled
Arati Kanchi, MDStudy DirectorHorizon Therapeutics

Media Library

HZN-825 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05626751 — Phase 2
Systemic Sclerosis Research Study Groups: HZN-825
Systemic Sclerosis Clinical Trial 2023: HZN-825 Highlights & Side Effects. Trial Name: NCT05626751 — Phase 2
HZN-825 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05626751 — Phase 2

Frequently Asked Questions

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

Are there still opportunities for participants to join this experiment?

"That is accurate. According to information on clinicaltrials.gov, this medical trial which was initially published on November 4th 2022, continues seeking participants actively. 300 people need to be recruited at 1 centre for the study's completion."

Answered by AI

Has the FDA granted clearance to HZN-825?

"Our team has assessed HZN-825's safety to be a 2, as there is some documentation confirming the medication's security but no clinical evidence of its efficacy."

Answered by AI

How many individuals have opted to take part in this experiment?

"Affirmative. Clinicaltrials.gov displays that this clinical trial is presently seeking participants, with the initial posting occurring on November 4th 2022 and an update made on November 15th 2022. 300 individuals must be enrolled from 1 site in total."

Answered by AI
~154 spots leftby Jul 2026