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HZN-825 for Systemic Sclerosis

Centro de Investigaciones Reumatologicas, San Miguel De Tucumán, Argentina
Systemic Sclerosis+1 More ConditionsHZN-825 - Drug
Eligibility
18+
All Sexes

Study Summary

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

Eligible Conditions
  • Systemic Sclerosis
  • Progressive Systemic Sclerosis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

11 Primary · 0 Secondary · Reporting Duration: Day 1 to Week 56

Baseline to Week 52
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 trial baseline in abnormal and clinically significant 12-lead ECG measurements.
Change from trial baseline in abnormal and clinically significant 12-lead electrocardiogram (ECG) measurements.
Change from trial baseline, defined as the latest measurement prior to the first dose of HZN-825 in FVC % predicted
Week 52
Incidence of adverse events of special interest (AESI) orthostatic hypotension
Week 56
Change from HZN-825 baseline in abnormal laboratory test results
Change from HZN-825 baseline in vital signs as reported as TEAEs
Change from trial baseline in abnormal laboratory test results
Change from trial baseline in vital signs as reported as TEAEs
Incidence and frequency of use of concomitant medication
Incidence of treatment emergent adverse events (TEAEs)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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11C-BMS-986196
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

HZN-825
1 of 1

Experimental Treatment

300 Total Participants · 1 Treatment Group

Primary Treatment: HZN-825 · No Placebo Group · Phase 2

HZN-825
Drug
Experimental Group · 1 Intervention: HZN-825 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to week 56

Who is running the clinical trial?

Horizon Pharma Ireland, Ltd., Dublin IrelandLead Sponsor
29 Previous Clinical Trials
3,132 Total Patients Enrolled
Arati Kanchi, MDStudy DirectorHorizon Therapeutics

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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