A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

April 24, 2024 updated by: Horizon Therapeutics Ireland DAC

A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 6 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks.

The trial will include up to a 42-day Screening Period and a 52-week Double-blind Treatment Period. Participants will take their first dose of trial drug at the clinic and will participate in trial visits at Week 4 and every 6 weeks thereafter until Week 52.

All participants who complete the Double-blind Treatment Period (Week 52) will be eligible to enter a 52-week extension trial (HZNP-HZN-825-302, NCT05626751). Participants not entering the extension trial will participate in a Safety Follow-up Visit 4 weeks after the last dose of trial drug.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • 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 Contact

Study Locations

  • Argentina
      • Ciudad Autónoma de Buenos Aires, Argentina, C1015
        • Recruiting
        • Organización Médica de Investigación
        • Contact:
        • Principal Investigator:
          • Patricio Tate, MD
      • Ciudad Autónoma de Buenos Aires, Argentina, C1406AGA
        • Recruiting
        • Aprillus Asistencia e Investigacion de Arcis Salud SRL
        • Contact:
        • Principal Investigator:
          • Pablo Mannucci Walter, MD
      • Ciudad Autónoma de Buenos Aires, Argentina, C1426
        • Recruiting
        • Consultorio Médico Dra. Rivera
        • Contact:
        • Principal Investigator:
          • Oscar Luis Rillo, MD
      • Ciudad Autónoma de Buenos Aires, Argentina, C1430
        • Recruiting
        • Clinica Adventista Belgrano
        • Contact:
        • Principal Investigator:
          • Federico Ariel, MD
      • Mendoza, Argentina, M5500CPH
        • Recruiting
        • I.R. Medical Center - Hospital de Dia
        • Principal Investigator:
          • Alfredo Luis Borgia, MD
        • Contact:
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, B1902COS
        • Recruiting
        • Framingham Centro Médico
        • Contact:
        • Principal Investigator:
          • Juan Pedro Russo, MD
    • Ciudad Autónoma De BuenosAires
      • Recoleta, Ciudad Autónoma De BuenosAires, Argentina, C1111AAL
        • Withdrawn
        • Consultorios Médicos Dr. Catalán Pellet
    • Tucumán
      • San Miguel De Tucumán, Tucumán, Argentina, T4000AXL
        • Recruiting
        • Consultorio de Investigaciones Reumatologicas
        • Contact:
        • Principal Investigator:
          • Maria Silvia Yacuzzi, MD
      • San Miguel de Tucuman, Tucumán, Argentina, T4000AXL
        • Recruiting
        • Centro de Investigaciones Medicas Tucuman
        • Contact:
        • Principal Investigator:
          • Horacio Berman, MD
      • San Miguel de Tucumán, Tucumán, Argentina, T4000
        • Recruiting
        • Clinica Mayo de U.M.C.B. S.R.L
        • Contact:
        • Principal Investigator:
          • Francisco Colombres, MD
  • Austria
      • Wien, Austria, 1090
        • Recruiting
        • Medizinische Universitat Wien (Medical University of Vienna)
        • Contact:
    • Steiermark
      • Graz, Steiermark, Austria, 8010
        • Recruiting
        • Medizinische Universität Graz
        • Contact:
        • Principal Investigator:
          • Martin Helmut Stradner, MD
  • Chile
      • Santiago, Chile, 8330034
        • Recruiting
        • Centro de Investigación Clínica de la Universidad Católica
        • Contact:
          • Maria Soledad Navarrete
          • Phone Number: +56955043334
          • Email: msnavarr@uc.cl
        • Principal Investigator:
          • Antonia Valenzuela Vergara, MD
    • Valparaíso
      • Viña del Mar, Valparaíso, Chile, 2520612
  • France
      • Paris, France, 75014
        • Recruiting
        • Hopital Cochin
        • Contact:
        • Principal Investigator:
          • Yannick Allanore, MD
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67000
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • Recruiting
        • Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin
        • Contact:
        • Principal Investigator:
          • Marie-Elise Truchetet, MD
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31000
        • Recruiting
        • Hôpital de Rangueil
        • Contact:
        • Principal Investigator:
          • Gregory Pugnet, MD
    • Nord
      • Lille, Nord, France, 59000
        • Recruiting
        • Hopital Claude Huriez
        • Contact:
        • Principal Investigator:
          • Eric Hachulla, MD
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité - Universitätsmedizin Berlin
        • Contact:
        • Principal Investigator:
          • Robert Biesen, MD
      • Dresden, Germany, 1307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus an der TU Dresden
        • Contact:
        • Principal Investigator:
          • Claudia Günther, MD
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
        • Recruiting
        • Universitatsklinikum Freiburg
        • Principal Investigator:
          • Stephanie Finzel, MD
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Recruiting
        • Friedrich Alexander Universität Erlangen Nürnberg
        • Contact:
        • Principal Investigator:
          • Christina Bergmann, MD
      • München, Bayern, Germany, 80336
        • Not yet recruiting
        • LMU Klinikum der Universität
        • Principal Investigator:
          • Hendrik Schulze-Koops, MD
      • Würzburg, Bayern, Germany, 97080
        • Recruiting
        • Universitätsklinikum Würzburg
        • Contact:
        • Principal Investigator:
          • Marc Schmalzing, MD
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37075
        • Active, not recruiting
        • Universität Georg August
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 6120
        • Recruiting
        • Universitatsklinikum Halle (Saale)
        • Contact:
        • Principal Investigator:
          • Gernot Keyßer, MD
  • Greece
      • Thessaloniki, Greece, 564 29
        • Recruiting
        • Ippokratio General Hospital of Thessaloniki
        • Contact:
        • Principal Investigator:
          • Theodoros Dimitroulas, MD
      • Thessaloniki, Greece, 546 36
        • Recruiting
        • Kianous Stavros
        • Contact:
        • Principal Investigator:
          • Lucas Settas, MD, PhD
    • Attiki
      • Athens, Attiki, Greece, 115 27
        • Recruiting
        • Laiko General Hospital of Athens
        • Contact:
        • Principal Investigator:
          • Petros Sfikakis, MD
      • Athina, Attiki, Greece, 115 27
        • Recruiting
        • Laiko General Hospital of Athens
        • Principal Investigator:
          • Panayiotis Vlachoyiannopoulos
  • Israel
      • Haifa, Israel, 34362
        • Recruiting
        • Lady Davis Carmel Medical Center
        • Contact:
        • Principal Investigator:
          • Devy Zisman, MD
      • Haifa, Israel, 31096
        • Recruiting
        • Rambam Medical Center - PDDS
        • Contact:
        • Principal Investigator:
          • Alexandra Balbir-Gurman, MD
      • Petah tikva, Israel, 49100
        • Recruiting
        • Rabin Medical Center
        • Contact:
        • Principal Investigator:
          • Yair Molad, MD
      • Tel HaShomer, Israel, 52621
        • Recruiting
        • Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Merav Merav, MD
    • HaMerkaz
      • Kfar Sava, HaMerkaz, Israel, 44281
        • Recruiting
        • Meir Medical Center
        • Contact:
        • Principal Investigator:
          • Yair Levy, MD
    • Tel-Aviv
      • Tel Aviv-Yafo, Tel-Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Contact:
        • Principal Investigator:
          • Irena Irena, MD
  • Italy
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Contact:
        • Principal Investigator:
          • Marta Mosca, MD
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italy, 33100
        • Not yet recruiting
        • Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
        • Principal Investigator:
          • Luca Quartuccio, MD
    • Lazio
      • Roma, Lazio, Italy, 00168
    • Liguria
      • Genova, Liguria, Italy, 16132
        • Recruiting
        • Ospedale Policlinico San Martino
        • Contact:
        • Principal Investigator:
          • Maurizio Cutolo, MD
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele S.r.l. - PPDS
        • Contact:
        • Principal Investigator:
          • Lorenzo Dagna, MD
      • Pavia, Lombardia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo di Pavia
        • Contact:
        • Principal Investigator:
          • Carlomaurizio Montecucco, MD
      • Rozzano, Lombardia, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Contact:
        • Principal Investigator:
          • Carlo Selmi, MD
    • Toscana
      • Firenze, Toscana, Italy, 50141
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi
        • Contact:
        • Principal Investigator:
          • Marco Matucci Cerinic, MD
  • Japan
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
        • Contact:
        • Principal Investigator:
          • Hiroaki Niiro, MD
      • Tokyo, Japan, 104-8560
        • Recruiting
        • St. Luke's International Hospital
        • Contact:
        • Principal Investigator:
          • Futoshi Iwata
      • Tokyo, Japan, 113-8603
        • Recruiting
        • Nippon Medical School Hospital
        • Contact:
        • Principal Investigator:
          • Masataka Kuwana, MD, PhD
    • Aiti
      • Toyoake-shi, Aiti, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital
        • Contact:
        • Principal Investigator:
          • Hidekata Yasuoka, BCh, MD, PhD
    • Hokkaidô
      • Sapporo-Shi, Hokkaidô, Japan, 060-0061
        • Recruiting
        • Sapporo Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Hiroki Takahashi, MD, PhD
      • Sapporo-Shi, Hokkaidô, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
        • Principal Investigator:
          • Masaru Kato
    • Kumamoto
      • Kumamoto-Shi, Kumamoto, Japan, 860-0811
        • Recruiting
        • Kumamoto University Hospital
        • Principal Investigator:
          • Shinya Hirata, MD
        • Contact:
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
        • Principal Investigator:
          • Tomonori Ishii
    • Nagasaki
      • Nagasaki-Shi, Nagasaki, Japan, 852-8501
        • Recruiting
        • Nagasaki University Hospital
        • Contact:
        • Principal Investigator:
          • Atsushi Kawakami, MD
    • Saitama
      • Iruma-Gun, Saitama, Japan, 350-0495
        • Recruiting
        • Saitama Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Toshihide Mimura, MD, PhD
      • Kitamoto-Shi, Saitama, Japan, 364-0026
        • Recruiting
        • Kitasato University Medical Center
        • Contact:
        • Principal Investigator:
          • Sumiaki Tanaka, MD
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
        • Contact:
        • Principal Investigator:
          • Masakazu Matsushita, MD
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Not yet recruiting
        • Tokyo Women's Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Yasushi Kawaguchi, MD
    • Ôsaka
      • Suita-Shi, Ôsaka, Japan, 565-0871
        • Recruiting
        • Osaka University Hospital
        • Contact:
        • Principal Investigator:
          • Yoshihito Shima, MD
      • Takatsuki-Shi, Ôsaka, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital
        • Principal Investigator:
          • Tohru Takeuchi, MD
        • Contact:
  • Korea, Republic of
      • Gwangju, Korea, Republic of, 61469
        • Recruiting
        • Chonnam National University Hospital
        • Principal Investigator:
          • Shin-Seok Lee, MD
        • Contact:
      • Seoul, Korea, Republic of, 6273
        • Recruiting
        • Gangnam Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • Min-Chan Park, MD
        • Contact:
    • Gyeonggido
      • Seongnam, Gyeonggido, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Yun-Jong Lee, MD
    • Seoul Teugbyeolsi
      • Seongdong-gu, Seoul Teugbyeolsi, Korea, Republic of, 4763
        • Recruiting
        • Hanyang University Seoul Hospital
        • Contact:
        • Principal Investigator:
          • Jae-Bum Jun, MD
  • Mexico
      • Guadalajara, Mexico, 44650
        • Recruiting
        • Clinica de Investigacion en Reumatologia y Obesidad
        • Contact:
        • Principal Investigator:
          • Sergio Duran-Barragan, MD
    • Distrito Federal
      • Ciudad de México, Distrito Federal, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contact:
        • Principal Investigator:
          • Tatiana Rodriguez-Reyna, MD
      • Mexico, Distrito Federal, Mexico, 6700
        • Recruiting
        • CITER, Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV
        • Contact:
        • Principal Investigator:
          • Gabriel Medrano-Ramirez, MD
      • Miguel Hidalgo, Distrito Federal, Mexico, 11850
        • Recruiting
        • Centro de Investigación y Tratamiento Reumatológico S.C
        • Contact:
        • Principal Investigator:
          • Fedra Irazoque-Palazuelos, MD
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44690
        • Recruiting
        • Centro de Estudios de Investigacion Basica Y Clinica SC
        • Contact:
        • Principal Investigator:
          • Ignacio Garcia-Valladares, MD
      • Guadalajara, Jalisco, Mexico, ZC 44160
        • Recruiting
        • Centro Integral Reumatologia SA de CV
        • Contact:
        • Principal Investigator:
          • Hilario Avila Armengol, MD
    • San Luis Potosí
      • Burócratas del Estado, San Luis Potosí, Mexico, 78213
        • Recruiting
        • Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC
        • Contact:
        • Principal Investigator:
          • Juan Rizo Rodríguez, MD
    • Yucatán
      • Merida, Yucatán, Mexico, 97000
        • Recruiting
        • Unidad de Atencion Medica e Investigacion en Salud
        • Contact:
        • Principal Investigator:
          • Angélica Vanessa Angulo Ramírez, MD
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • Universitair Medisch Centrum Groningen
        • Contact:
        • Principal Investigator:
          • Alja Stel, MD
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333 ZA
        • Withdrawn
        • Leids Universitair Medisch Centrum
  • Poland
      • Kraków, Poland, 30-510
        • Recruiting
        • MCM Krakow - PRATIA
        • Principal Investigator:
          • Mariusz Korkosz, MD, PhD
        • Contact:
      • Łódź, Poland, 91-363
        • Recruiting
        • FutureMeds - Lodz - PPDS
        • Contact:
        • Principal Investigator:
          • Dorota Lis-Studniarska
    • Lubuskie
      • Nowa Sól, Lubuskie, Poland, 67-100
        • Recruiting
        • Twoja Przychodnia NCM
        • Principal Investigator:
          • Malgorzata Miakisz, MD
        • Contact:
    • Malopolskie
      • Kraków, Malopolskie, Poland, 30-149
        • Recruiting
        • Malopolskie Centrum Kliniczne
        • Contact:
        • Principal Investigator:
          • Ewa Zimmer-Satora, MD
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 00-874
        • Recruiting
        • Medicover Integrated Clinical Services sp. z o.o
        • Contact:
        • Principal Investigator:
          • Katarzyna Romanowska-Prochnicka, MD
      • Warszawa, Mazowieckie, Poland, 02-665
        • Recruiting
        • Centrum Medyczne Reuma Park NZOZ
        • Principal Investigator:
          • Anna Zubrzycka-Sienkiewicz, MD
        • Contact:
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-545
        • Recruiting
        • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi
        • Contact:
        • Principal Investigator:
          • Wlodzimierz Samborski, MD, PhD
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • Hospital de Braga
        • Principal Investigator:
          • Joana Silva, MD
        • Contact:
      • Coimbra, Portugal, 3000-459
        • Recruiting
        • Centro Hospitalar E Universitário de Coimbra EPE
        • Principal Investigator:
          • Maria João Henriques, MD
        • Contact:
      • Lisboa, Portugal, 1649-035
        • Recruiting
        • Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
        • Contact:
        • Principal Investigator:
          • Catarina Resende, MD
      • Ponte De Lima, Portugal, 4990-041
        • Recruiting
        • Hospital Conde de Bertiandos Unidade Local de Saúde Do Alto Minho
        • Contact:
        • Principal Investigator:
          • Jose Costa, MD
      • Porto, Portugal, 4200-319
    • Setúbal
      • Almada, Setúbal, Portugal, 2805-267
        • Recruiting
        • Hospital Garcia de Orta
        • Principal Investigator:
          • Ana Cordeiro, MD
        • Contact:
  • Romania
      • Brasov, Romania, 500283
        • Recruiting
        • Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL
        • Principal Investigator:
          • Liliana Duca, MD
      • Bucuresti, Romania, 20475
        • Recruiting
        • Dr I Cantacuzino Clinical Hospital
        • Contact:
        • Principal Investigator:
          • Ana Maria Gheorghiu, MD
    • Bucuresti
      • Bucharest, Bucuresti, Romania, 11172
        • Recruiting
        • Sf.Maria Clinical Hospital
        • Principal Investigator:
          • Violeta Bojinca, MD, PhD
      • Bucharest, Bucuresti, Romania, 11172
        • Withdrawn
        • Sf.Maria Clinical Hospital
  • Spain
      • Barcelona, Spain, 008035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Alfredo Guillen del Castillo, MD
      • Barcelona, Spain, 8025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Principal Investigator:
          • Ivan Castellvi Barranco, MD
        • Contact:
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
        • Contact:
        • Principal Investigator:
          • Julia Martinez Barrio, MD
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz - PPDS
        • Contact:
        • Principal Investigator:
          • Alejandro Balsa Criado, MD
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Alejandro Muñoz Jimenez
      • Sevilla, Spain, 41010
        • Recruiting
        • Hospital Quironsalud Infanta Luisa
        • Contact:
        • Principal Investigator:
          • Noemi Garrido Puñal, MD
      • Valencia, Spain, 46017
        • Recruiting
        • Hospital Universitario Doctor Peset
        • Contact:
        • Principal Investigator:
          • Juan Jose Alegre, MD
      • a Coruña, Spain, 15006
        • Recruiting
        • Hospital Universitario A Coruña
        • Principal Investigator:
          • Francisco Javier Blanco Garcia, MD
        • Contact:
    • Badajoz
      • Merida, Badajoz, Spain, 6800
        • Recruiting
        • Hospital de Merida-Avenida d' Antonio Campos Hoyos 26
        • Contact:
        • Principal Investigator:
          • Eugenio Chamizo Carmona, MD
    • Barcelona
      • Sabadell, Barcelona, Spain, 8208
        • Recruiting
        • Corporacio Sanitaria Parc Tauli
        • Contact:
        • Principal Investigator:
          • Joan Calvet Fontova, MD
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Principal Investigator:
          • Ricardo Blanco Alonso, MD
    • Córdoba
      • Cordoba, Córdoba, Spain, 14004
        • Recruiting
        • C.H. Regional Reina Sofia
        • Contact:
        • Principal Investigator:
          • Rafaela Ortega Castro
  • Switzerland
      • Fribourg, Switzerland, 1708
        • Recruiting
        • HFR Fribourg Hôpital Cantonal
        • Contact:
        • Principal Investigator:
          • Jean Dudler, MD
      • Sankt Gallen, Switzerland, 9000
        • Recruiting
        • Kantonsspital St. Gallen
        • Principal Investigator:
          • Andrea Rubbert-Roth, MD
    • Bern (de)
      • Bern, Bern (de), Switzerland, 3010
        • Recruiting
        • Inselspital Bern
        • Principal Investigator:
          • Britta Maurer, MD
  • United Kingdom
    • London, City Of
      • London, London, City Of, United Kingdom, NW3 2QG
        • Recruiting
        • The Royal Free Hospital
        • Contact:
        • Principal Investigator:
          • Christopher Denton, PhD
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Arizona Arthritis and Rheumatology Research, PLLC
        • Contact:
        • Principal Investigator:
          • Saima Chohan, MD
    • California
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Pacific Arthritis Care Center
        • Principal Investigator:
          • Daniel Furst, MD
        • Contact:
      • Los Angeles, California, United States, 90095-1670
        • Recruiting
        • UCLA Department of Medicine
        • Contact:
        • Principal Investigator:
          • Elizabeth Volkmann, MD
      • Stanford, California, United States, 94305-2200
        • Recruiting
        • Stanford University School of Medicine
        • Principal Investigator:
          • Lorinda Chung, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine
        • Principal Investigator:
          • Eric Greidinger, MD
        • Contact:
      • Plantation, Florida, United States, 33324
        • Recruiting
        • IRIS Research and Development LLC
        • Contact:
        • Principal Investigator:
          • Guillermo Valenzuela, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • DelRicht Clinical Research, LLC
        • Contact:
        • Principal Investigator:
          • Lesley Saketkoo, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02118-2642
        • Recruiting
        • Boston University School Of Medicine
        • Contact:
        • Principal Investigator:
          • Marcin Trojanowski, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Michigan Medicine University of Michigan
        • Contact:
        • Principal Investigator:
          • Carleigh Zahn
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic - Cancer Center - Rochester - PPDS
        • Principal Investigator:
          • Ashima Makol, MD
        • Contact:
    • New York
      • New York, New York, United States, 10021-4823
        • Recruiting
        • Hospital for Special Surgery
        • Contact:
        • Principal Investigator:
          • Robert Spiera, MD
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Recruiting
        • Duke University Medical Center
        • Contact:
        • Principal Investigator:
          • Ankoor Shah, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • South Carolina
      • Charleston, South Carolina, United States, 29425-8900
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Richard Silver, MD
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Metroplex Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Stanley Cohen, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT Physicians Rheumatology
        • Contact:
        • Principal Investigator:
          • Maureen Mayes, MD

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Written informed consent.
  2. Male or female between the ages of 18 and 75 years, inclusive, at Screening.
  3. Meets the 2013 American College of Rheumatology/European League Against Rheumatism classification criteria for SSc with a total score of ≥9 (Van den Hoogen et al., 2013).
  4. Classified as having skin involvement proximal to the elbow and knee (diffuse cutaneous SSc subset by LeRoy and Medsger, 2001).
  5. At the time of enrollment, less than or equal to 72 months (6 years) since the onset of the first SSc manifestation, other than Raynaud's phenomenon.
  6. Skin thickening from SSc in the forearm suitable for repeat biopsy.
  7. mRSS units ≥15 at Screening.
  8. FVC ≥45% predicted at Screening, as determined by spirometry.
  9. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.

Exclusion Criteria:

  1. Positive for anti-centromere antibodies with the exception that subjects who are positive for both anti-centromere and anti-topoisomerase 1 antibodies may be enrolled.
  2. Diagnosed with sine scleroderma or limited cutaneous SSc.
  3. Diagnosed with other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma-associated myopathy and secondary Sjogren's syndrome.
  4. Scleroderma renal crisis diagnosed within 6 months of the Screening Visit.

  5. Any of the following cardiovascular diseases:

    1. uncontrolled, severe hypertension (≥160/100 mmHg) or persistent low blood pressure (systolic blood pressure <90 mmHg) within 6 months of Screening,
    2. myocardial infarction within 6 months of Screening,
    3. unstable cardiac angina within 6 months of Screening.
  6. DLCO <40% predicted (corrected for hemoglobin). If severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure is of clinical concern for any subject, consider using a DLCO up to 6 months before the Screening Visit.
  7. Pulmonary arterial hypertension (PAH) by right heart catheterization requiring treatment with more than 1 oral PAH-approved therapy or any parenteral therapy. Treatment is allowed for erectile dysfunction and/or Raynaud's phenomenon/digital ulcers.
  8. Corticosteroid use for conditions other than SSc within 4 weeks prior to Screening (topical steroids for dermatological conditions and inhaled/intranasal/intra-articular steroids are allowed).
  9. Use of any other non-steroid immunosuppressive agent, small biologic molecule, cytotoxic or anti-fibrotic drug within 4 weeks of Screening, including cyclophosphamide, azathioprine (Imuran®) or other immunosuppressive or cytotoxic medication. Exceptions include mycophenolate mofetil (CellCept®), mycophenolic acid (Myfortic®), methotrexate and low-dose prednisone, as follows: use of CellCept ≤3 g/day, Myfortic ≤2.14 g/day, methotrexate ≤20 mg/week and prednisone ≤10 mg/day (or equivalent dosing of glucocorticoids) is allowed. Subjects taking CellCept, Myfortic or methotrexate must have been doing so for ≥6 months and the dose must have been stable for ≥4 weeks prior to the Day 1 Visit. Prednisone must have been at a stable dose for ≥8 weeks prior to the Day 1 Visit. It is acceptable to be on background low-dose prednisone and anti-malarial drug along with CellCept, Myfortic or methotrexate. Rituximab must not have been used within 6 months of the Day 1 Visit.
  10. Known active bacterial, viral, fungal, mycobacterial or other infection, including tuberculosis or atypical mycobacterial disease (fungal infections of nail beds are allowed) at the time of randomization.
  11. Use of a United States Food and Drug Administration-approved agent for SSc or an investigational agent for any condition within 90 days or 5 half-lives, whichever is longer, prior to Screening or anticipated use during the course of the trial.
  12. Malignant condition in the past 5 years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
  13. Women of childbearing potential or male subjects not agreeing to use highly effective method(s) of birth control throughout the trial and for 1 month after last dose of trial drug. Male subjects must refrain from sperm donation and females from egg/ova donation for this same time period.
  14. Pregnant or lactating women.
  15. Current drug or alcohol abuse or history of either within the previous 2 years, in the opinion of the Investigator or as reported by the subject.
  16. Previous enrollment in this trial or participation in a prior HZN-825 or SAR100842 clinical trial.
  17. Known history of positive test for human immunodeficiency virus (HIV). HIV testing is optional based on Investigator assessment, institutional practices or local guidelines to rule out suspected HIV or potential for a positive HIV result. Subject consent is required prior to HIV testing.
  18. Active hepatitis (hepatitis B: positive hepatitis B surface antigen and positive anti-hepatitis B core antibody [anti-HBcAb] and negative hepatitis B surface antibody [HBsAb] or positive for HBcAb with a positive test for HBsAb and with presence of hepatitis B virus DNA at Screening; hepatitis C: positive anti-hepatitis C virus [anti-HCV] and positive RNA HCV).
  19. Current alcoholic liver disease, primary biliary cirrhosis or primary sclerosing cholangitis.
  20. Previous organ transplant (including allogeneic and autologous marrow transplant).
  21. International normalized ratio >2, prolonged prothrombin time >1.5 × the upper limit of normal (ULN) or partial thromboplastin time >1.5 × ULN at Screening.
  22. Alanine aminotransferase or aspartate aminotransferase >2 × ULN.
  23. Estimated glomerular filtration rate <30 mL/min/1.73 m^2 at Screening.
  24. Total bilirubin >2 × ULN. Subjects with documented diagnosis of Gilbert's syndrome may be enrolled if their total bilirubin is ≤3.0 mg/dL.
  25. Any other condition that, in the opinion of the Investigator, would preclude enrollment in the trial.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HZN-825 300 mg once daily (QD)
One set of 2 HZN-825 150mg tablets in the morning and one set of 2 placebo tablets in the evening.
Drug: HZN-825 QD
300 mg oral tablets QD
Experimental: HZN-825 300 mg twice daily (BID)
One set of 2 HZN-825 150mg tablets in the morning and one set of 2 HZN-825 150mg tablets in the evening.
Drug: HZN-825 BID
300 mg oral tablets BID
Placebo Comparator: Placebo
One set of 2 placebo tablets in the morning and one set of 2 placebo tablets in the evening.
Drug: Placebo
Placebo BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in FVC (forced vital capacity) percent predicted from Baseline to Week 52
Time Frame: Baseline to Week 52
As measured by a pulmonary function test called a spirometry.
Baseline to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in HAQ-DI (Health Assessment Questionnaire - Disability Index) at Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Change from Baseline in MDGA (Physician Global Assessment) at Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Change from Baseline in PTGA (Patient Global Assessment) at Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Change from Baseline in the Physical Effects subscale of the scleroderma skin patient-reported outcome (SSPRO-18) at Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Change from Baseline in the Physical Limitations subscale of the scleroderma skin patient-reported outcome SSPRO-18 at Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Proportion of participants with an mRSS (modified Rodnan skin score) decrease of ≥5 points and 25% from Baseline at Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Responder rate (defined as ACR-CRISS [predicted probability] of at least 0.6) at Week 52
Time Frame: Week 52
American College of Rheumatology-Composite Response Index in Systemic Sclerosis
Week 52
Proportion of participants with an improvement in ≥3 of 5 core measures from Baseline: ≥20% in mRSS, ≥20% in HAQ-DI, ≥20% in PTGA, ≥20% in MDGA and ≥5% for FVC % predicted at Week 52 (ACR-CRISS-20)
Time Frame: Baseline to Week 52
American College of Rheumatology-Composite Response Index in Systemic Sclerosis
Baseline to Week 52

Collaborators and Investigators

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

Sponsor

Horizon Therapeutics Ireland DAC

Investigators

  • Study Director: Medical Director, Horizon Therapeutics

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)

April 1, 2021

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HZNP-HZN-825-301
  • 2020-005764-62 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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