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

Diffuse Cutaneous Systemic Sclerosis Clinical Trial

Official title:

A Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05626751
• Other study ID #: HZNP-HZN-825-302
• Secondary ID: 2021-006271-42
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: November 4, 2022
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 246
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Cutaneous Systemic Sclerosis
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Sclerosis, Systemic

Intervention

Drug:
• HZN-825
HZN-825 will be administered BID for 52 weeks

Locations

Country	Name	City	State
Argentina	Aprillus Asistencia e Investigacion de Arcis Salud SRL	Ciudad Autónoma de Buenos Aires	Ciudad Autónoma De BuenosAires
Argentina	Clínica Adventista Belgrano	Cuiudad Autónoma De	Buenos Aires
Argentina	Framingham Centro Médico	La Plata	Buenos Aires
Argentina	I.R. Medical Center - Hospital de Dia	Mendoza
Argentina	Centro de Investigaciones Médicas Tucumán	San Miguel De Tucumán	Tucumán
Argentina	Centro de Investigaciones Reumatologicas	San Miguel De Tucumán	Tucumán
Argentina	Clinica Mayo de U.M.C.B. S.R.L	San Miguel De Tucumán	Tucumán
France	Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin	Bordeaux	Gironde
France	Hopital Cochin	Paris
Greece	Ippokratio General Hospital of Thessaloniki	Thessaloniki
Greece	Kianous Stavros	Thessaloniki
Israel	Tel Aviv Sourasky Medical Center - PPDS	Tel Aviv-Yafo	Tel-Aviv
Japan	Saitama Medical University Hospital	Iruma-Gun	Saitama
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Hanyang University Medical Center	Seoul
Mexico	Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC	Burocratas Del Estado	San Luis Potosí
Mexico	Centro de Estudios de Investigacion Basica Y Clinica SC	Guadalajara	Jalisco
Mexico	Centro Integral Reumatologia SA de CV	Guadalajara	Jalisco
Mexico	Clinica de Investigacion en Reumatologia y Obesidad	Guadalajara
Mexico	Unidad de Atencion Medica e Investigacion en Salud	Merida
Mexico	CITER, Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV	Mexico
Mexico	Centro de Investigación y Tratamiento Reumatológico S.C	San Miguel Chapultepec	Distrito Federal
Spain	Hospital Quironsalud Infanta Luisa	Sevilla
United States	Michigan Medicine University of Michigan	Ann Arbor	Michigan
United States	Medical University of South Carolina - PPDS	Charleston	South Carolina
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	UT Physicians Rheumatology	Houston	Texas
United States	DelRicht Clinical Research, LLC	New Orleans	Louisiana
United States	IRIS Research and Development LLC	Plantation	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  France,  Greece,  Israel,  Japan,  Korea, Republic of,  Mexico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from trial baseline, defined as the latest measurement prior to the first dose of HZN-825 in FVC % predicted	As measured by a pulmonary function test called a spirometry.	Baseline to Week 52
Primary	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	As measured by a pulmonary function test called a spirometry.	Baseline to Week 52
Primary	Incidence of treatment emergent adverse events (TEAEs)		Day 1 to Week 56
Primary	Incidence of adverse events of special interest (AESI) orthostatic hypotension		Day 1 to Week 52
Primary	Incidence and frequency of use of concomitant medication		Day 1 to Week 56
Primary	Change from trial baseline in vital signs as reported as TEAEs		Day 1 to Week 56
Primary	Change from HZN-825 baseline in vital signs as reported as TEAEs		Day 1 to Week 56
Primary	Change from trial baseline in abnormal and clinically significant 12-lead electrocardiogram (ECG) measurements.	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).	Baseline to Week 52
Primary	Change from HZN-825 trial baseline in abnormal and clinically significant 12-lead ECG measurements.	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).	Baseline to Week 52
Primary	Change from trial baseline in abnormal laboratory test results	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)	Day 1 to Week 56
Primary	Change from HZN-825 baseline in abnormal laboratory test results	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)	Day 1 to Week 56