An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)
Study Details
Study Description
Brief Summary
Primary Objectives:
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The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted.
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The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
This is an open-label, repeat-dose, multicenter extension trial of HZNP-HZN-825-301. Participants who complete the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301 will be eligible to enter this 52-week extension trial. Participants entering this extension trial will complete the Week 52 Visit activities in HZNP-HZN-825-301 and will not complete the Safety Follow-up Visit 4 weeks after the last dose of trial drug in HZNP-HZN-825-301.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HZN-825 HZN-825 will be administered by mouth (PO) twice daily (BID) for 52 weeks |
Drug: HZN-825
HZN-825 will be administered BID for 52 weeks
|
Outcome Measures
Primary Outcome Measures
- Change from trial baseline, defined as the latest measurement prior to the first dose of HZN-825 in FVC % predicted [Baseline to Week 52]
As measured by a pulmonary function test called a spirometry.
- 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 [Baseline to Week 52]
As measured by a pulmonary function test called a spirometry.
- Incidence of treatment emergent adverse events (TEAEs) [Day 1 to Week 56]
- Incidence of adverse events of special interest (AESI) orthostatic hypotension [Day 1 to Week 52]
- Incidence and frequency of use of concomitant medication [Day 1 to Week 56]
- Change from trial baseline in vital signs as reported as TEAEs [Day 1 to Week 56]
- Change from HZN-825 baseline in vital signs as reported as TEAEs [Day 1 to Week 56]
- Change from trial baseline in abnormal and clinically significant 12-lead electrocardiogram (ECG) measurements. [Baseline to Week 52]
Clinically significant changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT interval corrected using Fridericia's formula (QTcF).
- Change from HZN-825 trial baseline in abnormal and clinically significant 12-lead ECG measurements. [Baseline to Week 52]
Clinically significant changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT interval corrected using Fridericia's formula (QTcF).
- Change from trial baseline in abnormal laboratory test results [Day 1 to Week 56]
Clinically significant lab values in serum chemistry, hematology, lipids, coagulation tests and urinalyses will be assessed (including Grade 3 or higher per common terminology criteria for adverse events)
- Change from HZN-825 baseline in abnormal laboratory test results [Day 1 to Week 56]
Clinically significant lab values in serum chemistry, hematology, lipids, coagulation tests and urinalyses will be assessed (including Grade 3 or higher per common terminology criteria for adverse events)
Eligibility Criteria
Criteria
Key Inclusion Criteria:
- Completed the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301; participants prematurely discontinued from trial drug in Trial HZNP-HZN-825-301 for reasons other than safety or toxicity can be included at the discretion of the Investigator after completing Trial HZNP-HZN-825-301 scheduled visits, including Week 52 assessments.
Key Exclusion Criteria:
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Anticipated use of another investigational agent for any condition during the course of the trial.
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Women of childbearing potential (WOCBP) or male participants not agreeing to use highly effective method(s) of birth control throughout the trial and for 4 weeks after last dose of trial drug as defined in the protocol.
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Any new development with the participant's disease or condition or any significant laboratory test abnormality during the course of Trial HZNP-HZN-825-301 that, in the opinion of the Investigator, would potentially put the subject at unacceptable risk.
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Pregnant or lactating women.
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Participants will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the trial protocol or have a concomitant disease or condition that could interfere with the conduct of the trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | DelRicht Clinical Research, LLC | New Orleans | Louisiana | United States | 70115 |
Sponsors and Collaborators
- Horizon Pharma Ireland, Ltd., Dublin Ireland
Investigators
- Study Director: Arati Kanchi, MD, Horizon Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HZNP-HZN-825-302
- 2021-006271-42