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An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)

Phase 2
Terminated
Conditions
Diffuse Cutaneous Systemic Sclerosis
Sclerosis, Systemic
Interventions
Registration Number
NCT05626751
Lead Sponsor
Amgen
Brief Summary

Primary Objectives:

1. 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.

2. 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.

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.

Acquired from Horizon in 2024.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
174
Inclusion Criteria
  1. 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
  1. Anticipated use of another investigational agent for any condition during the course of the trial.
  2. New diagnosis of malignant condition after enrolling in Trial HZNP-HZN-825-301 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
  3. 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.
  4. 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.
  5. Pregnant or lactating women.
  6. 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
HZN-825HZN-825HZN-825 will be administered by mouth (PO) twice daily (BID) for 52 weeks
Primary Outcome Measures
NameTimeMethod
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 % predictedBaseline to Week 52

As measured by a pulmonary function test called a spirometry.

Incidence of adverse events of special interest (AESI) orthostatic hypotensionDay 1 to Week 52
Incidence and frequency of use of concomitant medicationDay 1 to Week 56
Change from trial baseline in vital signs as reported as TEAEsDay 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).

Incidence of treatment emergent adverse events (TEAEs)Day 1 to Week 56
Change from trial baseline, defined as the latest measurement prior to the first dose of HZN-825 in FVC % predictedBaseline to Week 52

As measured by a pulmonary function test called a spirometry.

Change from trial baseline in abnormal laboratory test resultsDay 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 resultsDay 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 vital signs as reported as TEAEsDay 1 to Week 56
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).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (65)

Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd

🇺🇸

Phoenix, Arizona, United States

UCLA Medical Center

🇺🇸

Los Angeles, California, United States

University of Miami Miller School of Medicine

🇺🇸

Miami, Florida, United States

IRIS Research and Development LLC

🇺🇸

Plantation, Florida, United States

DelRicht Clinical Research, LLC - Internal - Covington - PPDS

🇺🇸

New Orleans, Louisiana, United States

Boston University School Of Medicine

🇺🇸

Boston, Massachusetts, United States

Michigan Medicine University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

Mayo Clinic - Cancer Center - Rochester - PPDS

🇺🇸

Rochester, Minnesota, United States

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

Medical University of South Carolina (MUSC) - PPDS

🇺🇸

Charleston, South Carolina, United States

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Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd
🇺🇸Phoenix, Arizona, United States

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