A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis (eSScape)

October 15, 2026 updated by: argenx

A Randomized, Double-Blinded, Placebo-Controlled, Phase 2, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Adult Participants With Systemic Sclerosis

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1405BFN
        • Instituto de Investigación Clínica TyT
      • Buenos Aires, Argentina, C1046AAQ
        • Aprillus Asistencia e Investigacion
      • Buenos Aires, Argentina, C1426ABP
        • Consultorios Médicos Dr. Doreski - Fundacion Respirar
      • Buenos Aires, Argentina
        • Hospital General de Agudos Dr. José María Ramos Mejia
      • Córdoba, Argentina, 5000
        • Sanatorio Allende S.A.
      • San Miguel de Tucumán, Argentina, T4000IAP
        • Centro de Investigaciones Reumatológicas
      • San Miguel de Tucumán, Argentina, T4000IHE
        • Clínica Mayo de U.M.C.B. S.R.L
      • San Miguel de Tucumán, Argentina, T4000IKJ
        • Centro de Investigaciones Médicas Tucumán
  • Belgium
      • Ghent, Belgium, 9000
        • UZ Gent
      • Jette, Belgium, 1090
        • UZ Brussel
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Medical Center Artmed OOD
      • Sofia, Bulgaria, 1680
        • Diagnostic Consultative Center Convex EOOD
  • Chile
      • Santiago, Chile, 8330034
        • Centro de Investigaciones Clinicas UC (CICUC)
      • Santiago, Chile, 8320000
        • BIOCINETIC Ltda
      • Temuco, Chile, 4810345
        • Centro de especialidades médicas Vanguardia
  • Croatia
      • Osijek, Croatia, 31000
        • Clinical Hospital Centre Osijek
      • Split, Croatia, 21000
        • University Hospital of Split
      • Zadar, Croatia, 23000
        • General Hospital Zadar
  • Czechia
      • Prague, Czechia, 140 59
        • Revmatologicky Ustav
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux - Hôpital Pellegrin
      • Lille, France, 59000
        • CHU de Lille - Hopital Claude Huriez
      • Marseille, France, 13274
        • CHU de Strasbourg - Hôpital de Hautepierre
      • Montpellier, France, 34090
        • CHU de Montpellier- Hôpital Saint Eloi
      • Paris, France, 75014
        • AP-HP - Hôpital Cochin - Port-Royal, site Cochin
    • Nord
      • Lille, Nord, France, 59000
        • CHU de Lille - Hopital Claude Huriez
  • Germany
      • Bad Bramstedt, Germany, 24576
        • Auenlandklinik Bad Bramstedt GmbH
      • Lübeck, Germany, 23562
        • Universitätsklinikum Schleswig-Holstein - Campus Lübeck
      • Minden, Germany, 32429
        • Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen
  • Greece
      • Pátrai, Greece, 265 04
        • University General Hospital of Patras
      • Pátrai, Greece, 264 43
        • Olympion General Clinic
      • Thessaloniki, Greece, 546 36
        • Euromedica Kianous Stavros
  • Hungary
      • Pécs, Hungary, 7632
        • Pecsi Tudomanyegyetem, Klinika Kozpont, Bor, Nemikortani es Onkodermatologiai Klinika
  • Italy
      • Florence, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Milan, Italy, 20132
        • Ospedale San Raffaele S.r.l.
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena
      • Naples, Italy, 80131
        • Azienda Ospedaliera Universitaria Luigi Vanvitelli
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
      • Roma, Italy, 128
        • Fondazione Policlinico Universitario Campus Bio-Medico
      • Rozzano, Italy, 20089
        • IRCCS Istituto Clinico Humanitas
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kauno klinikos
      • Klaipėda, Lithuania, LT-92288
        • Klaipeda Hospital, Affiliate of Klaipeda University Hospital
  • Mexico
      • Chihuahua City, Mexico, 31203
        • Mediadvance Clinical S.A.P.I. de C.V.
      • Guadalajara, Mexico, 44160
        • Centro Integral Reumatologia SA de CV
      • Mexico City, Mexico, 11850
        • Centro de Investigación y Tratamiento Reumatológico S.C
      • Mérida, Mexico, 97070
        • Medical Care and Research S.A. de C.V.
    • Tlalpan
      • Belisario Domínguez, Tlalpan, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Leids Universitair Medisch Centrum
  • Poland
      • Krakow, Poland, 30-002
        • Malopolskie Badania Kliniczne
      • Lublin, Poland, 20-607
        • Zespol Poradni Specjalistycznych REUMED
      • Nowa Sól, Poland, 67-100
        • Twoja Przychodnia NCM
      • Warsaw, Poland, 00-874
        • MICS Centrum Medyczne Warszawa
      • Wroclaw, Poland, 53-224
        • Niepubliczny Zaklad Opieki Zdrowotnej Biogenes
  • Portugal
      • Lisbon, Portugal, 1349-019
        • ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
      • Lisbon, Portugal, 1649-035
        • ULS de Santa Maria,EPE - Hospital de Santa Maria
      • Vila Nova de Gaia, Portugal, 4434-502
        • ULS de Gaia/Espinho, EPE - Unidade I
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • The Alliance Medical Sciences Campus
  • Romania
      • Bucharest, Romania, 11172
        • Sf.Maria Clinical Hospital
      • Bucharest, Romania, 20475
        • Dr I Cantacuzino Clinical Hospital
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute of Rheumatology - PPDS
      • Belgrade, Serbia, 11152
        • Military Medical Academy
  • Spain
      • Barcelona, Spain, 8023
        • Hospital Del Mar
      • Córdoba, Spain, 14004
        • C.H. Regional Reina Sofia
      • Sabadell, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
  • Switzerland
      • Sankt Gallen, Switzerland, 9000
        • Kantonsspital St. Gallen
      • Zurich, Switzerland, 8090
        • Universitätsspital Zürich
  • United Kingdom
      • Leeds, United Kingdom, LS7 4SA
        • Chapel Allerton Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • Luton, United Kingdom, LU4 0DZ
        • Luton and Dunstable University Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032-9306
        • Arizona Arthritis and Rheumatology Associates
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Ronald Reagan University of California Los Angeles Medical Center
    • Florida
      • Plantation, Florida, United States, 33324
        • IRIS Research and Development LLC
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois Health Outpatient Care Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • DelRicht Research, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Asthma and Allergy Center
      • Columbia, Maryland, United States, 21044
        • Thomas Jefferson University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Perelman Center for Advanced Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Efgartigimod PH20 SC

Participants receiving efgartigimod PH20 SC
Combination product: Efgartigimod PH20 SC

Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Placebo Comparator: Placebo PH20 SC

Participants receiving placebo PH20 SC
Other: Placebo PH20 SC

Subcutaneous placebo PH20 SC given by prefilled syringe

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in mRSS at week 24
Time Frame: Up to 24 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 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent (serious) adverse events
Time Frame: Up to 55 weeks
Up to 55 weeks
Efgartigimod serum concentrations over time
Time Frame: Up to 48 weeks
Up to 48 weeks
Percent change from baseline in total IgG levels in serum over time
Time Frame: Up to 55 weeks
Up to 55 weeks
Incidence of anti-drug antibodies against efgartigimod in serum over time
Time Frame: Up to 55 weeks
Up to 55 weeks
Incidence of antibodies against rHuPH20 in plasma over time
Time Frame: Up to 55 weeks
Up to 55 weeks
Change from baseline in mRSS at week 48
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Change from baseline in PGA at weeks 24 and 48
Time Frame: 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
Change from baseline in CGA at weeks 24 and 48
Time Frame: 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
Time Frame: Up to 48 weeks

Forced Vital Capacity is a tool to assess lung function
Up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
argenx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ARGX-113-2317
  • 2024-514539-67-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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