En studie for å vurdere effektiviteten og sikkerheten til Efgartigimod PH20 SC hos voksne med systemisk sklerose (eSScape)
En randomisert, dobbeltblindet, placebokontrollert, fase 2, parallellgruppestudie for å evaluere effektiviteten, sikkerheten, tolerabiliteten, farmakodynamikken, farmakokinetikken og immunogenisiteten til Efgartigimod PH20 SC hos voksne deltakere med systemisk sklerose
The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis. The study consists of a screening period, a treatment period of up to 48 weeks and a safety follow-up period. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod PH20 SC or placebo. The total study duration can be up to approximately 15 months.
More information can be found on: https://clinicaltrials.argenx.com/esscape
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Buenos Aires, Argentina, C1405BFN
- Instituto de Investigación Clínica TyT
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Buenos Aires, Argentina, C1046AAQ
- Aprillus Asistencia e Investigacion
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Buenos Aires, Argentina, C1426ABP
- Consultorios Médicos Dr. Doreski - Fundacion Respirar
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Buenos Aires, Argentina
- Hospital General de Agudos Dr. José María Ramos Mejia
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Córdoba, Argentina, 5000
- Sanatorio Allende S.A.
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San Miguel de Tucumán, Argentina, T4000IAP
- Centro de Investigaciones Reumatológicas
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San Miguel de Tucumán, Argentina, T4000IHE
- Clínica Mayo de U.M.C.B. S.R.L
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San Miguel de Tucumán, Argentina, T4000IKJ
- Centro de Investigaciones Médicas Tucumán
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Ghent, Belgia, 9000
- UZ Gent
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Jette, Belgia, 1090
- UZ Brussel
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Plovdiv, Bulgaria, 4002
- Medical Center Artmed OOD
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Sofia, Bulgaria, 1680
- Diagnostic Consultative Center Convex EOOD
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Santiago, Chile, 8330034
- Centro de Investigaciones Clinicas UC (CICUC)
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Santiago, Chile, 8320000
- BIOCINETIC Ltda
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Temuco, Chile, 4810345
- Centro de especialidades médicas Vanguardia
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Copenhagen, Danmark, 2100
- Rigshospitalet
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Arizona
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Phoenix, Arizona, Forente stater, 85032-9306
- Arizona Arthritis and Rheumatology Associates
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California
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Los Angeles, California, Forente stater, 90095
- UCLA Ronald Reagan University of California Los Angeles Medical Center
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Florida
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Plantation, Florida, Forente stater, 33324
- IRIS Research and Development LLC
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Illinois
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Chicago, Illinois, Forente stater, 60612
- University of Illinois Health Outpatient Care Center
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Louisiana
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New Orleans, Louisiana, Forente stater, 70112
- DelRicht Research, LLC
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Maryland
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Baltimore, Maryland, Forente stater, 21224
- Johns Hopkins Asthma and Allergy Center
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Columbia, Maryland, Forente stater, 21044
- Thomas Jefferson University
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- University of Michigan Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Perelman Center for Advanced Medicine
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Bordeaux, Frankrike, 33000
- CHU de Bordeaux - Hôpital Pellegrin
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Lille, Frankrike, 59000
- CHU de Lille - Hopital Claude Huriez
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Marseille, Frankrike, 13274
- CHU de Strasbourg - Hôpital de Hautepierre
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Montpellier, Frankrike, 34090
- CHU de Montpellier- Hôpital Saint Eloi
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Paris, Frankrike, 75014
- AP-HP - Hôpital Cochin - Port-Royal, site Cochin
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Nord
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Lille, Nord, Frankrike, 59000
- CHU de Lille - Hopital Claude Huriez
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Pátrai, Hellas, 265 04
- University General Hospital of Patras
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Pátrai, Hellas, 264 43
- Olympion General Clinic
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Thessaloniki, Hellas, 546 36
- Euromedica Kianous Stavros
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Florence, Italia, 50134
- Azienda Ospedaliera Universitaria Careggi
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Milan, Italia, 20132
- Ospedale San Raffaele S.r.l.
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Modena, Italia, 41124
- Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena
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Naples, Italia, 80131
- Azienda Ospedaliera Universitaria Luigi Vanvitelli
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Roma, Italia, 00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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Roma, Italia, 128
- Fondazione Policlinico Universitario Campus Bio-Medico
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Rozzano, Italia, 20089
- IRCCS Istituto Clinico Humanitas
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Osijek, Kroatia, 31000
- Clinical Hospital Centre Osijek
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Split, Kroatia, 21000
- University Hospital of Split
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Zadar, Kroatia, 23000
- General Hospital Zadar
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Kaunas, Litauen, 50161
- Hospital of Lithuanian University of Health Sciences Kauno klinikos
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Klaipėda, Litauen, LT-92288
- Klaipeda Hospital, Affiliate of Klaipeda University Hospital
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Chihuahua City, Mexico, 31203
- Mediadvance Clinical S.A.P.I. de C.V.
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Guadalajara, Mexico, 44160
- Centro Integral Reumatologia SA de CV
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Mexico City, Mexico, 11850
- Centro de Investigación y Tratamiento Reumatológico S.C
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Mérida, Mexico, 97070
- Medical Care and Research S.A. de C.V.
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Tlalpan
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Belisario Domínguez, Tlalpan, Mexico, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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Leiden, Nederland, 2333 ZA
- Leids Universitair Medisch Centrum
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Krakow, Polen, 30-002
- Malopolskie Badania Kliniczne
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Lublin, Polen, 20-607
- Zespol Poradni Specjalistycznych REUMED
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Nowa Sól, Polen, 67-100
- Twoja Przychodnia NCM
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Warsaw, Polen, 00-874
- MICS Centrum Medyczne Warszawa
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Wroclaw, Polen, 53-224
- Niepubliczny Zaklad Opieki Zdrowotnej Biogenes
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Lisbon, Portugal, 1349-019
- ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
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Lisbon, Portugal, 1649-035
- ULS de Santa Maria,EPE - Hospital de Santa Maria
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Vila Nova de Gaia, Portugal, 4434-502
- ULS de Gaia/Espinho, EPE - Unidade I
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San Juan, Puerto Rico, 00936
- The Alliance Medical Sciences Campus
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Bucharest, Romania, 11172
- Sf.Maria Clinical Hospital
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Bucharest, Romania, 20475
- Dr I Cantacuzino Clinical Hospital
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Belgrade, Serbia, 11000
- Institute of Rheumatology - PPDS
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Belgrade, Serbia, 11152
- Military Medical Academy
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Barcelona, Spania, 8023
- Hospital Del Mar
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Córdoba, Spania, 14004
- C.H. Regional Reina Sofia
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Sabadell, Spania, 08208
- Corporacio Sanitaria Parc Tauli
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Leeds, Storbritannia, LS7 4SA
- Chapel Allerton Hospital
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London, Storbritannia, NW3 2QG
- Royal Free Hospital
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Luton, Storbritannia, LU4 0DZ
- Luton and Dunstable University Hospital
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Sankt Gallen, Sveits, 9000
- Kantonsspital St. Gallen
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Zurich, Sveits, 8090
- Universitätsspital Zürich
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Prague, Tsjekkia, 140 59
- Revmatologicky Ustav
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Bad Bramstedt, Tyskland, 24576
- Auenlandklinik Bad Bramstedt GmbH
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Lübeck, Tyskland, 23562
- Universitätsklinikum Schleswig-Holstein - Campus Lübeck
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Minden, Tyskland, 32429
- Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
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Tübingen, Tyskland, 72076
- Universitätsklinikum Tübingen
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Pécs, Ungarn, 7632
- Pecsi Tudomanyegyetem, Klinika Kozpont, Bor, Nemikortani es Onkodermatologiai Klinika
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Is aged ≥18 years and the local legal age of consent for clinical studies
- Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR/EULAR classification criteria
- Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160
- Has a Health Assessment Questionnaire-Disability Index (HAQ-DI) score of at least 0.5 OR a Patient Global Assessment (PGA) score of at least 3
- Has a modified Rodnan Skin Score (mRSS) score between 15 and 35
- The participant is anti-RNA polymerase III autoantibody negative at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 5 years before screening or the participant is anti-RNA polymerase III autoantibody positive at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 2 years before screening
- Has uninvolved or mildly thickened skin area in at least 1 injection site
Exclusion Criteria:
- Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory
- Significant Pulmonary Arterial Hypertension
- Severe digital vasculopathy within the past 3 months
- Skin thickening due to scleroderma mimics or localized scleroderma
- Scleroderma renal crisis within the past 6 months of participating to the study
- Another rheumatic autoimmune disease, except for secondary Sjögren's syndrome or fibromyalgia
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Efgartigimod PH20 SC
Participants receiving efgartigimod PH20 SC |
Subcutaneous efgartigimod PH20 SC given by prefilled syringe |
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Placebo komparator: Placebo PH20 SC
Participants receiving placebo PH20 SC |
Subcutaneous placebo PH20 SC given by prefilled syringe |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline in mRSS at week 24
Tidsramme: Up to 24 weeks
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The Modified Rodnan Skin Score is a scoring tool to assess skin thickness in 17 cutaneous sites across the body. Each site is rated on a semiquantitative score ranging from 0 (normal) to 3 (severe). The total score is the sum of the individual skin scores and can range from 0 to 51. |
Up to 24 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Forekomst av behandlingsfremkallende (alvorlige) bivirkninger
Tidsramme: Opptil 55 uker
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Opptil 55 uker
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Efgartigimod serumkonsentrasjoner over tid
Tidsramme: Inntil 48 uker
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Inntil 48 uker
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Prosentvis endring fra baseline i totale IgG-nivåer i serum over tid
Tidsramme: Opptil 55 uker
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Opptil 55 uker
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Forekomst av anti-legemiddelantistoffer mot efgartigimod i serum over tid
Tidsramme: Opptil 55 uker
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Opptil 55 uker
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Forekomst av antistoffer mot rHuPH20 i plasma over tid
Tidsramme: Opptil 55 uker
|
Opptil 55 uker
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Change from baseline in mRSS at week 48
Tidsramme: Up to 48 weeks
|
The Modified Rodnan Skin Score is a scoring tool to assess skin thickness in 17 cutaneous sites across the body. Each site is rated on a semiquantitative score ranging from 0 (normal) to 3 (severe). The total score is the sum of the individual skin scores and can range from 0 to 51. |
Up to 48 weeks
|
|
Proportion of participants who improve in at least 2 or at least 3 of the 5 core items of CRISS-25 at weeks 24 and 48 and do not have worsening in >1 component and have no significant SSc-related event(s)
Tidsramme: Up to 48 weeks
|
Revised Composite Response Index in Systemic Sclerosis (CRISS-25) is a global composite outcome assessment that provides a holistic perspective of the disease. It includes 5 core items: the Modified Rodnan Skin Score, the Clinician's global assessment, the Forced Vital Capacity, the Patient global assessment, and the Health Assessment Questionnaire-Disability Index. |
Up to 48 weeks
|
|
Change from baseline in HAQ-DI at weeks 24 and 48
Tidsramme: Up to 48 weeks
|
Health Assessment Questionnaire-Disability Index is a tool to assess physical function and disability. It consists of 8 categories with each question scored from 0 (without any difficulty) to 3 (unable to do). |
Up to 48 weeks
|
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Change from baseline in PGA at weeks 24 and 48
Tidsramme: Up to 48 weeks
|
Patient's Global Assessment is a tool that measures a participant's global evaluation of their overall health during the previous week using a 10-point numerical scale. The score varies between 0 (excellent overall health) and 10 (extremely poor overall health). |
Up to 48 weeks
|
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Change from baseline in CGA at weeks 24 and 48
Tidsramme: Up to 48 weeks
|
Clinician's Global Assessment is a tool that measures a clinician's assessment of the overall health of a participant during the previous week using a 10-point numerical scale. The score varies between 0 (excellent overall health) and 10 (extremely poor overall health). |
Up to 48 weeks
|
|
Annualized rate of decline in FVC (in mL) in participants with interstitial lung disease
Tidsramme: Up to 48 weeks
|
Forced Vital Capacity is a tool to assess lung function |
Up to 48 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ARGX-113-2317
- 2024-514539-67-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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