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Studies

Interventional Active not recruiting Phase 2

NCT06655155 on ClinicalTrials.gov

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

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

  • Sponsor: Argenx (Belgium)
  • Enrollment: 87 (Actual)
  • Study start: 2024-11-11 (Actual)
  • Primary completion: 2027-03-01 (Estimated)
  • Study completion: 2027-10-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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. 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)

Intervention / Treatment

  • Combination Product: Efgartigimod PH20 SC
  • Other: Placebo PH20 SC

Primary Outcome Measures

  • Change from baseline in mRSS at week 24 (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.

Countries

Argentina, Belgium, Bulgaria, Chile, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Lithuania, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Serbia, Spain, Switzerland, United Kingdom, United States

Locations and Investigators

  • Universitair Ziekenhuis Gent, Gent, Belgium
    • Vanessa, Smith
  • UZ Brussel, Jette, Belgium
    • Karin, Melsens
  • Diagnostics And Consultation Center Convex Ltd., Sofiya, Bulgaria
    • Vladimira, Boyadzhieva
  • Klinicki Bolnicki Centar Osijek, Osijek, Croatia
    • Jasminka, Milas-Ahic
  • KBC Split, Split, Croatia
    • Mislav, Radic
  • Opca Bolnica Zadar, Zadar, Croatia
    • Kristina, Frketic Marovic
  • Revmatologicky Ustav, Prague 2, Czechia
    • Michal, Tomčík
  • Rigshospitalet, Copenhagen Oe, Denmark
    • Søren, Jacobsen
  • Centre Hospitalier Universitaire De Bordeaux, Bordeaux, France
    • Marie-Elise, TRUCHETET
  • Assistance Publique Hopitaux De Paris, Paris, France
    • Yannick, ALLANORE
  • Hopital Huriez, Lille Cedex, France
    • Vincent, SOBANSKI
  • Centre Hospitalier Universitaire De Montpellier, Montpellier, France
    • Christian, JORGENSEN
  • Les Hopitaux Universitaires De Strasbourg, Strasbourg Cedex 2, France
    • Emmanuel, CHATELUS
  • Universitaetsklinikum Schleswig-Holstein AöR, Luebeck, Germany
    • Gabriela, Riemekasten
  • Klinikum Bad Bramstedt GmbH, Bad Bramstedt, Germany
  • Universitaetsklinikum Tuebingen AöR, Tuebingen, Germany
  • Johannes Wesling Klinikum Minden, Minden, Germany
    • Gunter, Aßmann
  • Olympion Therapeftirio General Clinic Of Patras S.A., Patra, Greece
    • Andreas, Bounas
  • General University Hospital Of Patras, Patras, Greece
    • Dimitrios, Daousis
  • Euromedica Kyanous Stavros, Thessaloniki, Greece
    • Lukas, Settas
  • University Of Pecs, Pecs, Hungary
    • Gábor, KUMÁNOVICS
  • Humanitas Mirasole S.p.A., Rozzano, Italy
    • Maria, De Santis
  • Ospedale San Raffaele S.r.l., Milan, Italy
    • Marco, Matucci Cerinic
  • Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli, Naples, Italy
    • Giovanna, Cuomo
  • Azienda Ospedaliero Universitaria Careggi, Florence, Italy
    • Silvia, Bellando Randone
  • Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon, Rome, Italy
    • Roberto, Giacomelli
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
    • Maria Antonietta, D'Agostino
  • Azienda Ospedaliero Universitaria Di Modena, Modena, Italy
    • Dilia, Giuggioli
  • Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos, Kaunas, Lithuania
    • Asta, Baranauskaitė
  • Klaipedos universiteto ligonine VšĮ, Klaipeda, Lithuania
    • Loreta, Loreta Bukauskienė
  • Leids Universitair Medisch Centrum (LUMC), Leiden, Netherlands
    • Jeska K., De Vries - Bouwstra
  • Reumed Sp. z o.o., Lublin, Poland
    • Robert, Zwolak
  • Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o, Wroclaw, Poland
    • Piotr, Wiland
  • Malopolskie Badania Kliniczne Sp. z o.o., Cracow, Poland
    • Bogdan, Batko
  • Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o., Nowa Sol, Poland
    • Małgorzata, Miakisz
  • MICS Centrum Medyczne Warszawa, Medicover Integrated Clinical Services Sp. z o.o, Warszawa, Poland
    • Katarzyna, Romanowska-Próchnicka
  • Saint Maria Hospital, Bucharest, Romania
    • Florian, Berghea
  • Spitalul Clinic Dr. I. Cantacuzino, Bucharest, Romania
    • Ana-Maria, Gheorghiu
  • Hospital Del Mar, Barcelona, Spain
    • Ana, Pros Simon
  • Parc Tauli Hospital Universitari, Sabadell, Spain
    • Joan, Calvet Fontova
  • Hospital Universitario Reina Sofia, Cordoba, Spain
    • Rafaela, Ortega Castro
  • Unidade Local De Saude De Gaia/Espinho E.P.E., Vila Nova De Gaia, Portugal
    • Tiago, Meirinhos
  • Unidade Local De Saude De Santa Maria E.P.E., Lisbon, Portugal
    • Catarina, Resende
  • Unidade Local De Saude De Lisboa Ocidental E.P.E., Lisbon, Portugal
    • Manuela, Costa