Clinical trial NCT05626751: An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diffuse Cutaneous Systemic Sclerosis
Sclerosis, Systemic
Keywords: Scleroderma
Forced vital capacity
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-11-25
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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
measure: 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
measure: Incidence of treatment emergent adverse events (TEAEs)
timeFrame: Day 1 to Week 56
measure: Incidence of adverse events of special interest (AESI) orthostatic hypotension
timeFrame: Day 1 to Week 52
measure: Incidence and frequency of use of concomitant medication
timeFrame: Day 1 to Week 56
measure: Change from trial baseline in vital signs as reported as TEAEs
timeFrame: Day 1 to Week 56
measure: Change from HZN-825 baseline in vital signs as reported as TEAEs
timeFrame: Day 1 to Week 56
measure: Change from trial baseline in abnormal and clinically significant 12-lead electrocardiogram (ECG) measurements.
timeFrame: Baseline to Week 52
measure: Change from HZN-825 trial baseline in abnormal and clinically significant 12-lead ECG measurements.
timeFrame: Baseline to Week 52
measure: Change from trial baseline in abnormal laboratory test results
timeFrame: Day 1 to Week 56
measure: Change from HZN-825 baseline in abnormal laboratory test results
timeFrame: Day 1 to Week 56
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development LLC
state: Florida
city: New Orleans
country: United States
facility: DelRicht Clinical Research, LLC - Internal - Covington - PPDS
state: Louisiana
city: Boston
country: United States
facility: Boston University School Of Medicine
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Medicine University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Cancer Center - Rochester - PPDS
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC) - PPDS
state: South Carolina
city: Houston
country: United States
facility: UT Physicians Rheumatology
state: Texas
city: La Plata
country: Argentina
facility: Framingham Centro Médico
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Consultorio Médico Dra. Rivera
state: Ciudad Autónoma De BuenosAires
city: San Miguel De Tucumán
country: Argentina
facility: Centro de Investigaciones Médicas Tucumán - PPDS
state: Tucumán
city: San Miguel De Tucumán
country: Argentina
facility: Centro de Investigaciones Reumatológicas
state: Tucumán
city: San Miguel De Tucumán
country: Argentina
facility: Clínica Mayo de U.M.C.B. S.R.L
state: Tucumán
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Aprillus Asistencia e Investigacion de Arcis Salud SRL
city: Cuiudad Autónoma De Buenos Aires
country: Argentina
facility: Clínica Adventista Belgrano
city: Mendoza
country: Argentina
facility: I.R. Medical Center - Hospital de Dia
city: Santiago
country: Chile
facility: Prosalud y Cia Ltda.
state: Región-MetropolitanadeSantiago
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
state: Attiki
city: Thessaloniki
country: Greece
facility: Euromedica Kianous Stavros
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki ''Hippokratio''
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center - PPDS
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center Ichilov - PPDS
state: Tel-Aviv
city: Haifa
country: Israel
facility: Rambam Health Care Campus - PPDS
city: Petah Tiqva
country: Israel
facility: Rabin Medical Center - PPDS
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
state: Friuli-Venezia Giulia
city: Sapporo-Shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaidô
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaidô
city: Nagasaki-Shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Iruma-Gun
country: Japan
facility: Saitama Medical University Hospital
state: Saitama
city: Bunkyo-Ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyo-Ku
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo
city: Takatsuki-Shi
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Ôsaka
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Gwangju Gwang'yeogsi
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggido
city: Seongdong-gu
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: Distrito Federal
city: San Miguel Chapultepec
country: Mexico
facility: Centro de Investigación y Tratamiento Reumatológico S.C
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica Y Clinica SC
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro Integral Reumatologia SA de CV
state: Jalisco
city: Burócratas del Estado
country: Mexico
facility: Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC
state: San Luis Potosí
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad
city: Merida
country: Mexico
facility: Unidad de Atencion Medica e Investigacion en Salud
city: Mexico
country: Mexico
facility: CITER, Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV
city: Nowa Sól
country: Poland
facility: Twoja Przychodnia NCM
state: Lubuskie
city: Kraków
country: Poland
facility: Malopolskie Centrum Kliniczne
state: Malopolskie
city: Warszawa
country: Poland
facility: Medicover Integrated Clinical Services sp. z o.o - MICS - PPDS
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Medyczne Reuma Park NZOZ
state: Mazowieckie
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria-Avenida Prof. Egas Moniz - PPDS
city: Bucharest
country: Romania
facility: Sf.Maria Clinical Hospital
state: Bucuresti
city: Bucharest
country: Romania
facility: Dr I Cantacuzino Clinical Hospital
state: Bucuresti
city: Brasov
country: Romania
facility: Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL
city: Belgrade
country: Serbia
facility: Institute of Rheumatology - PPDS
city: Niška Banja
country: Serbia
facility: Institute for Treatment and Rehabilitation Niska Banja
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: a Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Sevilla
country: Spain
facility: Hospital Quironsalud Infanta Luisa
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: London
country: United Kingdom
facility: Royal Free Hospital
state: London, City Of
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: