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Terminated/Withdrawn
Sponsor ID
HZNP-HZN-825-302

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

Sponsor ID
HZNP-HZN-825-302
Clinicaltrials.gov ID
NCT05626751
EUCTIS ID
2023-509783-23-00
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
174
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change from trial baseline, defined as the latest measurement prior to the first dose of HZN-825 in FVC % predicted

Timeframe: 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

Timeframe: Baseline to Week 52

Incidence of treatment emergent adverse events (TEAEs)

Timeframe: Day 1 to Week 56

Incidence of adverse events of special interest (AESI) orthostatic hypotension

Timeframe: Day 1 to Week 52

Incidence and frequency of use of concomitant medication

Timeframe: Day 1 to Week 56

Change from trial baseline in vital signs as reported as TEAEs

Timeframe: Day 1 to Week 56

Change from HZN-825 baseline in vital signs as reported as TEAEs

Timeframe: Day 1 to Week 56

Change from trial baseline in abnormal and clinically significant 12-lead electrocardiogram (ECG) measurements.

Timeframe: Baseline to Week 52

Change from HZN-825 trial baseline in abnormal and clinically significant 12-lead ECG measurements.

Timeframe: Baseline to Week 52

Change from trial baseline in abnormal laboratory test results

Timeframe: Day 1 to Week 56

Change from HZN-825 baseline in abnormal laboratory test results

Timeframe: Day 1 to Week 56

Secondary Outcome Measures
Not Available

Study Documents

Plain Language Summary of Results
Available Language(s): English, Spanish, Romanian, Polish, Korean, Italian, Greek, German, French, German (Austria), Spanish (Latin America), Portuguese (Native)
Download Document(s)

Locations

Location
Status
Contact Us
Location
Saitama Medical University Hospital
Iruma-Gun, Saitama, Japan, 350-0495
Status
Recruiting
Location
Centro de Investigaciones Reumatológicas
San Miguel De Tucumán, Tucumán, Argentina, T4000AXL
Status
Recruiting
Location
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel De Tucumán, Tucumán, Argentina, T4000AXL
Status
Recruiting
Location
Aprillus Asistencia e Investigacion de Arcis Salud SRL
Ciudad Autónoma de Buenos Aires, Argentina, C1406AGA
Status
Recruiting
Location
Clínica Adventista Belgrano
Cuiudad Autónoma de Buenos Aires, Argentina, C1430EGF
Status
Recruiting
Location
Framingham Centro Médico
La Plata, Buenos Aires, Argentina, B1900
Status
Recruiting
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Study Info
Age
N/A
Condition
  • Diffuse Cutaneous Systemic Sclerosis
    • Show more
  • Sclerosis
    • Sex
    All
    Trial Dates
    Nov 2022 - Feb 2025
    Inclusion and Exclusion Criteria
    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.
    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.