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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 March 2025
• Main ID: NCT05626751
• Date of registration: 01/11/2022
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)
• Scientific title: A Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis
• Date of first enrolment: November 4, 2022
• Target sample size: 174
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT05626751
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Argentina, Austria, Chile, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Romania, Serbia, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Key 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.


Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sclerosis, Systemic

Diffuse Cutaneous Systemic Sclerosis

Intervention(s)

Drug: HZN-825

Primary Outcome(s)

Incidence of adverse events of special interest (AESI) orthostatic hypotension [Time Frame: Day 1 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 [Time Frame: Baseline to Week 52]

Change from trial baseline in abnormal and clinically significant 12-lead electrocardiogram (ECG) measurements. [Time Frame: Baseline to Week 52]

Change from HZN-825 baseline in abnormal laboratory test results [Time Frame: Day 1 to Week 56]

Change from trial baseline, defined as the latest measurement prior to the first dose of HZN-825 in FVC % predicted [Time Frame: Baseline to Week 52]

Incidence and frequency of use of concomitant medication [Time Frame: Day 1 to Week 56]

Change from trial baseline in abnormal laboratory test results [Time Frame: Day 1 to Week 56]

Change from HZN-825 baseline in vital signs as reported as TEAEs [Time Frame: Day 1 to Week 56]

Incidence of treatment emergent adverse events (TEAEs) [Time Frame: Day 1 to Week 56]

Change from HZN-825 trial baseline in abnormal and clinically significant 12-lead ECG measurements. [Time Frame: Baseline to Week 52]

Change from trial baseline in vital signs as reported as TEAEs [Time Frame: Day 1 to Week 56]

Secondary ID(s)

2021-006271-42

HZNP-HZN-825-302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors