Actively Recruiting
A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
Led by argenx · Updated on 2026-04-23
81
Participants Needed
74
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect and safety of efgartigimod PH20 SC compared to a placebo in adults with systemic sclerosis. This phase 2, randomized, double-blinded study aims to assess how efgartigimod PH20 SC impacts skin symptoms in this condition. The study is sponsored by argenx and includes participants diagnosed with systemic sclerosis who meet specific classification and antibody criteria. Participants will be randomly assigned in a 2:1 ratio to receive either efgartigimod PH20 SC or a placebo, both given by subcutaneous injection using prefilled syringes. The treatment period can last up to 48 weeks. The study also includes a screening period before treatment and a safety follow-up period after treatment, with a total duration of about 15 months. During the study, participants will have regular assessments including skin scoring using the modified Rodnan Skin Score (mRSS), health questionnaires, and antibody testing. Researchers will monitor safety through tracking adverse events and measuring drug levels in the blood. The primary outcome measured is the change from baseline in mRSS at week 24. Follow-up evaluations continue up to 55 weeks to assess long-term effects and safety.
CONDITIONS
Brief Title
A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older and able to consent to participate
- Diagnosed with diffuse or limited systemic sclerosis meeting 2013 ACR/EULAR criteria
- Positive antinuclear antibody (ANA) test with titer of at least 1:160
- Health Assessment Questionnaire-Disability Index score of at least 0.5 or Patient Global Assessment score of at least 3
- Modified Rodnan Skin Score between 15 and 35
- Anti-RNA polymerase III negative with first non-Raynaud's symptom less than 5 years ago, or anti-RNA polymerase III positive with first non-Raynaud's symptom less than 2 years ago
- Presence of uninvolved or mildly thickened skin at at least one injection site
You will not qualify if you...
- Isolated anticentromere antibody positivity
- Significant pulmonary arterial hypertension
- Severe digital vasculopathy within the past 3 months
- Skin thickening caused by conditions other than systemic sclerosis
- Scleroderma renal crisis within the past 6 months
- Presence of other rheumatic autoimmune diseases, except secondary Sjögren's syndrome or fibromyalgia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive subcutaneous injections of either efgartigimod PH20 SC or placebo PH20 SC by prefilled syringe.
Visits occur according to the treatment schedule over the treatment period
Duration - Up to 7 weeks after treatment
Participants are monitored for safety and treatment effects after completing the treatment period.
Visits for safety monitoring and assessments
Trial Site Locations
Total: 74 locations
1
Arizona Arthritis and Rheumatology Associates
Phoenix, Arizona, United States, 85032-9306
Actively Recruiting
2
UCLA Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
3
IRIS Research and Development LLC
Plantation, Florida, United States, 33324
Actively Recruiting
4
University of Illinois Health Outpatient Care Center
Chicago, Illinois, United States, 60612
Actively Recruiting
5
DelRicht Research, LLC
New Orleans, Louisiana, United States, 70112
Actively Recruiting
6
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
7
Thomas Jefferson University
Columbia, Maryland, United States, 21044
Actively Recruiting
8
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
Aprillus Asistencia e Investigacion
Buenos Aires, Argentina, C1046AAQ
Actively Recruiting
11
Instituto de Investigación Clínica TyT
Buenos Aires, Argentina, C1405BFN
Actively Recruiting
12
Consultorios Médicos Dr. Doreski - Fundacion Respirar
Buenos Aires, Argentina, C1426ABP
Actively Recruiting
13
Hospital General de Agudos Dr. José María Ramos Mejia
Buenos Aires, Argentina
Actively Recruiting
14
Sanatorio Allende S.A.
Córdoba, Argentina, 5000
Actively Recruiting
15
Clínica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Argentina, T4000IHE
Actively Recruiting
16
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, Argentina, T4000IKJ
Actively Recruiting
17
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
18
UZ Brussel
Jette, Belgium, 1090
Actively Recruiting
19
Medical Center Artmed OOD
Plovdiv, Bulgaria, 4002
Actively Recruiting
20
Diagnostic Consultative Center Convex EOOD
Sofia, Bulgaria, 1680
Actively Recruiting
21
BIOCINETIC Ltda
Santiago, Chile, 8320000
Actively Recruiting
22
Centro de Investigaciones Clinicas UC (CICUC)
Santiago, Chile, 8330034
Actively Recruiting
23
Centro de especialidades médicas Vanguardia
Temuco, Chile, 4810345
Actively Recruiting
24
Clinical Hospital Centre Osijek
Osijek, Croatia, 31000
Actively Recruiting
25
University Hospital of Split
Split, Croatia, 21000
Actively Recruiting
26
General Hospital Zadar
Zadar, Croatia, 23000
Actively Recruiting
27
Revmatologicky Ustav
Prague, Czechia, 140 59
Actively Recruiting
28
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
29
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France, 33000
Actively Recruiting
30
CHU de Lille - Hopital Claude Huriez
Lille, France, 59000
Actively Recruiting
31
CHU de Strasbourg - Hôpital de Hautepierre
Marseille, France, 13274
Actively Recruiting
32
CHU de Montpellier- Hôpital Saint Eloi
Montpellier, France, 34090
Actively Recruiting
33
AP-HP - Hôpital Cochin - Port-Royal, site Cochin
Paris, France, 75014
Actively Recruiting
34
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Germany, 23562
Actively Recruiting
35
Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
Minden, Germany, 32429
Actively Recruiting
36
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
37
Olympion General Clinic
Pátrai, Greece, 264 43
Actively Recruiting
38
University General Hospital of Patras
Pátrai, Greece, 265 04
Actively Recruiting
39
Euromedica Kianous Stavros
Thessaloniki, Greece, 546 36
Actively Recruiting
40
Pecsi Tudomanyegyetem, Klinika Kozpont, Bor, Nemikortani es Onkodermatologiai Klinika
Pécs, Hungary, 7632
Actively Recruiting
41
Azienda Ospedaliera Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
42
Ospedale San Raffaele S.r.l.
Milan, Italy, 20132
Actively Recruiting
43
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, Italy, 80131
Actively Recruiting
44
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
45
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy, 128
Actively Recruiting
46
IRCCS Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
47
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Lithuania, 50161
Actively Recruiting
48
Klaipeda Hospital, Affiliate of Klaipeda University Hospital
Klaipėda, Lithuania, LT-92288
Actively Recruiting
49
Mediadvance Clinical S.A.P.I. de C.V.
Chihuahua City, Mexico, 31203
Actively Recruiting
50
Centro Integral Reumatologia SA de CV
Guadalajara, Mexico, 44160
Actively Recruiting
51
Centro de Investigación y Tratamiento Reumatológico S.C
Mexico City, Mexico, 11850
Actively Recruiting
52
Medical Care and Research S.A. de C.V.
Mérida, Mexico, 97070
Actively Recruiting
53
Leids Universitair Medisch Centrum
Leiden, Netherlands, 2333 ZA
Actively Recruiting
54
Malopolskie Badania Kliniczne
Krakow, Poland, 30-002
Actively Recruiting
55
Zespol Poradni Specjalistycznych REUMED
Lublin, Poland, 20-607
Actively Recruiting
56
Twoja Przychodnia NCM
Nowa Sól, Poland, 67-100
Actively Recruiting
57
MICS Centrum Medyczne Warszawa
Warsaw, Poland, 00-874
Actively Recruiting
58
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes
Wroclaw, Poland, 53-224
Actively Recruiting
59
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, Portugal, 1349-019
Actively Recruiting
60
ULS de Santa Maria,EPE - Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Actively Recruiting
61
ULS de Gaia/Espinho, EPE - Unidade I
Vila Nova de Gaia, Portugal, 4434-502
Actively Recruiting
62
The Alliance Medical Sciences Campus
San Juan, Puerto Rico, 00936
Actively Recruiting
63
Sf.Maria Clinical Hospital
Bucharest, Romania, 11172
Actively Recruiting
64
Dr I Cantacuzino Clinical Hospital
Bucharest, Romania, 20475
Actively Recruiting
65
Institute of Rheumatology - PPDS
Belgrade, Serbia, 11000
Actively Recruiting
66
Military Medical Academy
Belgrade, Serbia, 11152
Actively Recruiting
67
Hospital Del Mar
Barcelona, Spain, 8023
Actively Recruiting
68
C.H. Regional Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
69
Corporacio Sanitaria Parc Tauli
Sabadell, Spain, 08208
Actively Recruiting
70
Kantonsspital St. Gallen
Sankt Gallen, Switzerland, 9000
Actively Recruiting
71
Universitätsspital Zürich
Zurich, Switzerland, 8090
Actively Recruiting
72
Chapel Allerton Hospital
Leeds, United Kingdom, LS7 4SA
Actively Recruiting
73
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
74
Luton and Dunstable University Hospital
Luton, United Kingdom, LU4 0DZ
Actively Recruiting
Research Team
S
Sabine Coppieters, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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