Systemic Sclerosis (SSc)Phase 2eSScapeNCT06655155
A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
A Phase 2 study testing Efgartigimod PH20 SC in people with Systemic Sclerosis (SSc), run by argenx at 79 sites in 24 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis (SSc)
- What is being tested?
- Efgartigimod PH20 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 79 sitesin 24 countries
- Study dates
- 11 Nov 2024to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
79 sites in 24 countries.
79 sites in 24 countries
United States9 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, 21224
University of Illinois Health Outpatient Care Center
Chicago, Illinois, 60612
Thomas Jefferson University
Columbia, Maryland, 21044
UCLA Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California, 90095
DelRicht Research, LLC
New Orleans, Louisiana, 70112
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Arizona Arthritis and Rheumatology Associates
Phoenix, Arizona, 85032-9306
IRIS Research and Development LLC
Plantation, Florida, 33324
Argentina8 sites
Aprillus Asistencia e Investigacion
Buenos Aires, C1046AAQ
Instituto de Investigación Clínica TyT
Buenos Aires, C1405BFN
Consultorios Médicos Dr. Doreski - Fundacion Respirar
Buenos Aires, C1426ABP
Hospital General de Agudos Dr. José María Ramos Mejia
Buenos Aires
Sanatorio Allende S.A.
Córdoba, 5000
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, T4000IAP
Clínica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, T4000IHE
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, T4000IKJ
Italy7 sites
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Ospedale San Raffaele S.r.l.
Milan, 20132
Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena
Modena, 41124
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, 80131
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, 128
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
France6 sites
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33000
CHU de Lille - Hopital Claude Huriez
Lille, Nord, 59000
CHU de Lille - Hopital Claude Huriez
Lille, 59000
CHU de Strasbourg - Hôpital de Hautepierre
Marseille, 13274
CHU de Montpellier- Hôpital Saint Eloi
Montpellier, 34090
AP-HP - Hôpital Cochin - Port-Royal, site Cochin
Paris, 75014
Mexico5 sites
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Belisario Domínguez, Tlalpan, 14080
Mediadvance Clinical S.A.P.I. de C.V.
Chihuahua City, 31203
Centro Integral Reumatologia SA de CV
Guadalajara, 44160
Medical Care and Research S.A. de C.V.
Mérida, 97070
Centro de Investigación y Tratamiento Reumatológico S.C
Mexico City, 11850
Poland5 sites
Malopolskie Badania Kliniczne
Krakow, 30-002
Zespol Poradni Specjalistycznych REUMED
Lublin, 20-607
Twoja Przychodnia NCM
Nowa Sól, 67-100
MICS Centrum Medyczne Warszawa
Warsaw, 00-874
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes
Wroclaw, 53-224
Germany4 sites
Auenlandklinik Bad Bramstedt GmbH
Bad Bramstedt, 24576
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, 23562
Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
Minden, 32429
Universitätsklinikum Tübingen
Tübingen, 72076
Chile3 sites
BIOCINETIC Ltda
Santiago, 8320000
Centro de Investigaciones Clinicas UC (CICUC)
Santiago, 8330034
Centro de especialidades médicas Vanguardia
Temuco, 4810345
Croatia3 sites
Clinical Hospital Centre Osijek
Osijek, 31000
University Hospital of Split
Split, 21000
General Hospital Zadar
Zadar, 23000
Greece3 sites
Olympion General Clinic
Pátrai, 264 43
University General Hospital of Patras
Pátrai, 265 04
Euromedica Kianous Stavros
Thessaloniki, 546 36
Portugal3 sites
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, 1349-019
ULS de Santa Maria,EPE - Hospital de Santa Maria
Lisbon, 1649-035
ULS de Gaia/Espinho, EPE - Unidade I
Vila Nova de Gaia, 4434-502
Spain3 sites
Hospital Del Mar
Barcelona, 8023
C.H. Regional Reina Sofia
Córdoba, 14004
Corporacio Sanitaria Parc Tauli
Sabadell, 08208
United Kingdom3 sites
Chapel Allerton Hospital
Leeds, LS7 4SA
Royal Free Hospital
London, NW3 2QG
Luton and Dunstable University Hospital
Luton, LU4 0DZ
Bulgaria2 sites
Medical Center Artmed OOD
Plovdiv, 4002
Diagnostic Consultative Center Convex EOOD
Sofia, 1680
Lithuania2 sites
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, 50161
Klaipeda Hospital, Affiliate of Klaipeda University Hospital
Klaipėda, LT-92288
Romania2 sites
Sf.Maria Clinical Hospital
Bucharest, 11172
Dr I Cantacuzino Clinical Hospital
Bucharest, 20475
Serbia2 sites
Institute of Rheumatology - PPDS
Belgrade, 11000
Military Medical Academy
Belgrade, 11152
Switzerland2 sites
Kantonsspital St. Gallen
Sankt Gallen, 9000
Universitätsspital Zürich
Zurich, 8090
Hungary1 site
Pecsi Tudomanyegyetem, Klinika Kozpont, Bor, Nemikortani es Onkodermatologiai Klinika
Pécs, 7632
About this study
Official title: 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
- Conditions
- Systemic Sclerosis (SSc)
- Being tested
- Efgartigimod PH20 SC, Placebo PH20 SC
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efgartigimod PH20 SCCombination product
Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Placebo PH20 SCOther
Subcutaneous placebo PH20 SC given by prefilled syringe
| Study group | Role | What they receive |
|---|---|---|
| Efgartigimod PH20 SC | Experimental | Participants receiving efgartigimod PH20 SC Receives: Combination Product: Efgartigimod PH20 SC |
| Placebo PH20 SC | Placebo comparator | Participants receiving placebo PH20 SC Receives: Other: Placebo PH20 SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mRSS at week 24
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.
Measured: Up to 24 weeks
Secondary outcomes (11)
Change from baseline in mRSS at week 48
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.
Measured: Up to 48 weeks
Incidence of treatment-emergent (serious) adverse events
Measured: Up to 55 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)
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.
Measured: Up to 48 weeks
Change from baseline in HAQ-DI at weeks 24 and 48
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).
Measured: Up to 48 weeks
Change from baseline in PGA at weeks 24 and 48
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).
Measured: Up to 48 weeks
Change from baseline in CGA at weeks 24 and 48
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).
Measured: Up to 48 weeks
Annualized rate of decline in FVC (in mL) in participants with interstitial lung disease
Forced Vital Capacity is a tool to assess lung function
Measured: Up to 48 weeks
Efgartigimod serum concentrations over time
Measured: Up to 48 weeks
Percent change from baseline in total IgG levels in serum over time
Measured: Up to 55 weeks
Incidence of anti-drug antibodies against efgartigimod in serum over time
Measured: Up to 55 weeks
Incidence of antibodies against rHuPH20 in plasma over time
Measured: Up to 55 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start11 Nov 2024
- Primary completionMar 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655155
- Sponsor's protocol ID
- ARGX-113-2317
- Other IDs
- 2024-514539-67-00
- Acronym
- eSScape
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06655155
- Acronym / sponsor ID
- eSScape / ARGX-113-2317
- Conditions
- Systemic Sclerosis (SSc)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efgartigimod PH20 SC | Experimental | Combination Product: Efgartigimod PH20 SCParticipants receiving efgartigimod PH20 SC |
| Placebo PH20 SC | Placebo comparator | Other: Placebo PH20 SCParticipants receiving placebo PH20 SC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efgartigimod PH20 SCSubcutaneous efgartigimod PH20 SC given by prefilled syringe | Combination product | Efgartigimod PH20 SC |
| Placebo PH20 SCSubcutaneous placebo PH20 SC given by prefilled syringe | Other | Placebo PH20 SC |
Primary outcome
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.
11 secondary outcomes
Change from baseline in mRSS at week 48
Time frame: Up to 48 weeks
Incidence of treatment-emergent (serious) adverse events
Time frame: Up to 55 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
Change from baseline in HAQ-DI at weeks 24 and 48
Time frame: Up to 48 weeks
Change from baseline in PGA at weeks 24 and 48
Time frame: Up to 48 weeks
Change from baseline in CGA at weeks 24 and 48
Time frame: Up to 48 weeks
Annualized rate of decline in FVC (in mL) in participants with interstitial lung disease
Time frame: Up to 48 weeks
Efgartigimod serum concentrations over time
Time frame: Up to 48 weeks
Percent change from baseline in total IgG levels in serum over time
Time frame: Up to 55 weeks
Incidence of anti-drug antibodies against efgartigimod in serum over time
Time frame: Up to 55 weeks
Incidence of antibodies against rHuPH20 in plasma over time
Time frame: Up to 55 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
79 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efgartigimod PH20 SC in people with Systemic Sclerosis (SSc), run by argenx at 79 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Argentina, Italy, France, Mexico and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mRSS at week 24 (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.