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New shot could ease skin tightening in rare disease

NCT ID NCT06655155

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This study tests an experimental drug called efgartigimod PH20 SC in adults with systemic sclerosis, a disease that causes skin thickening and organ problems. About 81 participants will receive either the drug or a placebo as a shot under the skin for up to 48 weeks. Researchers will measure changes in skin thickness and check for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
efgartigimod PH20 SC (a drug given as a shot under the skin)
What this could lead to
If it works, this could point toward a new treatment to reduce skin thickening and other symptoms of systemic sclerosis.
What could go wrong
This is an early Phase 2 trial with only 81 people, so results may not apply to everyone. The drug may not improve symptoms or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 81 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic sclerosis (SSC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    77 sites in 24 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AP-HP - Hôpital Cochin - Port-Royal, site Cochin

    RECRUITING

    Paris, 75014, France

  • Aprillus Asistencia e Investigacion

    RECRUITING

    Buenos Aires, C1046AAQ, Argentina

  • Arizona Arthritis and Rheumatology Associates

    RECRUITING

    Phoenix, Arizona, 85032-9306, United States

  • Auenlandklinik Bad Bramstedt GmbH

    RECRUITING

    Bad Bramstedt, 24576, Germany

  • Azienda Ospedaliera Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli

    RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena

    RECRUITING

    Modena, 41124, Italy

  • BIOCINETIC Ltda

    RECRUITING

    Santiago, 8320000, Chile

  • C.H. Regional Reina Sofia

    RECRUITING

    Córdoba, 14004, Spain

  • CHU de Bordeaux - Hôpital Pellegrin

    RECRUITING

    Bordeaux, 33000, France

  • CHU de Lille - Hopital Claude Huriez

    RECRUITING

    Lille, 59000, France

  • CHU de Montpellier- Hôpital Saint Eloi

    RECRUITING

    Montpellier, 34090, France

  • CHU de Strasbourg - Hôpital de Hautepierre

    RECRUITING

    Marseille, 13274, France

  • Centro Integral Reumatologia SA de CV

    RECRUITING

    Guadalajara, 44160, Mexico

  • Centro de Investigaciones Clinicas UC (CICUC)

    RECRUITING

    Santiago, 8330034, Chile

    Contact Email: •••••@•••••

  • Centro de Investigaciones Médicas Tucumán

    RECRUITING

    San Miguel de Tucumán, T4000IKJ, Argentina

  • Centro de Investigaciones Reumatológicas

    RECRUITING

    San Miguel de Tucumán, T4000IAP, Argentina

  • Centro de Investigación y Tratamiento Reumatológico S.C

    RECRUITING

    Mexico City, 11850, Mexico

  • Centro de especialidades médicas Vanguardia

    RECRUITING

    Temuco, 4810345, Chile

  • Chapel Allerton Hospital

    RECRUITING

    Leeds, LS7 4SA, United Kingdom

  • Clinical Hospital Centre Osijek

    RECRUITING

    Osijek, 31000, Croatia

  • Clínica Mayo de U.M.C.B. S.R.L

    RECRUITING

    San Miguel de Tucumán, T4000IHE, Argentina

  • Consultorios Médicos Dr. Doreski - Fundacion Respirar

    RECRUITING

    Buenos Aires, C1426ABP, Argentina

  • Corporacio Sanitaria Parc Tauli

    RECRUITING

    Sabadell, 08208, Spain

  • DelRicht Research, LLC

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Diagnostic Consultative Center Convex EOOD

    RECRUITING

    Sofia, 1680, Bulgaria

  • Dr I Cantacuzino Clinical Hospital

    RECRUITING

    Bucharest, 20475, Romania

  • Euromedica Kianous Stavros

    RECRUITING

    Thessaloniki, 546 36, Greece

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • Fondazione Policlinico Universitario Campus Bio-Medico

    RECRUITING

    Roma, 128, Italy

  • General Hospital Zadar

    RECRUITING

    Zadar, 23000, Croatia

  • Hospital Del Mar

    RECRUITING

    Barcelona, 8023, Spain

  • Hospital General de Agudos Dr. José María Ramos Mejia

    RECRUITING

    Buenos Aires, Argentina

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    RECRUITING

    Kaunas, 50161, Lithuania

  • IRCCS Istituto Clinico Humanitas

    RECRUITING

    Rozzano, 20089, Italy

  • IRIS Research and Development LLC

    RECRUITING

    Plantation, Florida, 33324, United States

  • Institute of Rheumatology - PPDS

    RECRUITING

    Belgrade, 11000, Serbia

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    ACTIVE_NOT_RECRUITING

    Belisario Domínguez, Tlalpan, 14080, Mexico

  • Instituto de Investigación Clínica TyT

    RECRUITING

    Buenos Aires, C1405BFN, Argentina

  • Johns Hopkins Asthma and Allergy Center

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Kantonsspital St. Gallen

    RECRUITING

    Sankt Gallen, 9000, Switzerland

  • Klaipeda Hospital, Affiliate of Klaipeda University Hospital

    RECRUITING

    Klaipėda, LT-92288, Lithuania

  • Leids Universitair Medisch Centrum

    RECRUITING

    Leiden, 2333 ZA, Netherlands

  • Luton and Dunstable University Hospital

    RECRUITING

    Luton, LU4 0DZ, United Kingdom

  • MICS Centrum Medyczne Warszawa

    RECRUITING

    Warsaw, 00-874, Poland

  • Malopolskie Badania Kliniczne

    RECRUITING

    Krakow, 30-002, Poland

  • Mediadvance Clinical S.A.P.I. de C.V.

    RECRUITING

    Chihuahua City, 31203, Mexico

    Contact Email: •••••@•••••

  • Medical Care and Research S.A. de C.V.

    RECRUITING

    Mérida, 97070, Mexico

  • Medical Center Artmed OOD

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • Military Medical Academy

    RECRUITING

    Belgrade, 11152, Serbia

  • Mühlenkreiskliniken - Johannes Wesling Klinikum Minden

    RECRUITING

    Minden, 32429, Germany

  • Niepubliczny Zaklad Opieki Zdrowotnej Biogenes

    RECRUITING

    Wroclaw, 53-224, Poland

  • Olympion General Clinic

    RECRUITING

    Pátrai, 264 43, Greece

  • Ospedale San Raffaele S.r.l.

    RECRUITING

    Milan, 20132, Italy

  • Pecsi Tudomanyegyetem, Klinika Kozpont, Bor, Nemikortani es Onkodermatologiai Klinika

    RECRUITING

    Pécs, 7632, Hungary

  • Perelman Center for Advanced Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Revmatologicky Ustav

    RECRUITING

    Prague, 140 59, Czechia

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Royal Free Hospital

    RECRUITING

    London, NW3 2QG, United Kingdom

  • Sanatorio Allende S.A.

    RECRUITING

    Córdoba, 5000, Argentina

  • Sf.Maria Clinical Hospital

    RECRUITING

    Bucharest, 11172, Romania

  • The Alliance Medical Sciences Campus

    RECRUITING

    San Juan, 00936, Puerto Rico

  • Thomas Jefferson University

    RECRUITING

    Columbia, Maryland, 21044, United States

  • Twoja Przychodnia NCM

    RECRUITING

    Nowa Sól, 67-100, Poland

  • UCLA Ronald Reagan University of California Los Angeles Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • ULS de Gaia/Espinho, EPE - Unidade I

    RECRUITING

    Vila Nova de Gaia, 4434-502, Portugal

  • ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

    RECRUITING

    Lisbon, 1349-019, Portugal

  • ULS de Santa Maria,EPE - Hospital de Santa Maria

    RECRUITING

    Lisbon, 1649-035, Portugal

  • UZ Brussel

    RECRUITING

    Jette, 1090, Belgium

  • UZ Gent

    RECRUITING

    Ghent, 9000, Belgium

  • University General Hospital of Patras

    RECRUITING

    Pátrai, 265 04, Greece

  • University Hospital of Split

    RECRUITING

    Split, 21000, Croatia

  • University of Illinois Health Outpatient Care Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Michigan Hospital

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

    Contact Email: •••••@•••••

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    RECRUITING

    Lübeck, 23562, Germany

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, 72076, Germany

  • Universitätsspital Zürich

    RECRUITING

    Zurich, 8090, Switzerland

  • Zespol Poradni Specjalistycznych REUMED

    RECRUITING

    Lublin, 20-607, Poland

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