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A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
Sponsor: Boehringer Ingelheim
Summary
Nerandomilast is being developed to help people with systemic sclerosis by potentially improving symptoms and slowing disease progression. This study is open to adults who are at least 18 years old and have systemic sclerosis (SSc). People can join the study if they have limited or diffuse cutaneous SSc with disease onset within 7 years of the first non-Raynaud's symptom. The purpose of this study is to find out whether a medicine called nerandomilast helps people with systemic sclerosis. This study also aims to find out how well nerandomilast is tolerated in people with systemic sclerosis. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take the tablets twice a day. Participants are in the study for 1 to about 4 years. During this time, they visit the study site regularly and get phone calls from the site staff. During study visits participants regularly have blood samples taken and doctors check changes in skin thickening, lung function, and internal organs, overall health and the safety and tolerability of study treatment in people with SSc. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Official title: A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
448
Start Date
2026-06-09
Completion Date
2030-03-17
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Placebo matching nerandomilast formulation 1
Film-coated tablets
Placebo matching nerandomilast formulation 2
Film-coated tablets
Nerandomilast formulation 1
Film-coated tablets
Nerandomilast formulation 2
Film-coated tablets
Locations (211)
Banner - University Medicine Rheumatology Clinic
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Beverly Hills, California, United States
University of California Los Angeles
Los Angeles, California, United States
Paradigm Clinical Research - San Diego
San Diego, California, United States
Stanford University Medical Center
Stanford, California, United States
Amicus Arthritis and Osteoporosis Center
Whittier, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Georgetown University
Washington D.C., District of Columbia, United States
Millennium Research - Ormond Beach
Ormond Beach, Florida, United States
Integral Rheumatology and Immunology Specialist
Plantation, Florida, United States
BioResearch Partner - South Miami
South Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
DelRicht Research-New Orleans-64100
New Orleans, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Clinical Research Institute of Michigan, LLC - St. Clair Shores
Saint Clair Shores, Michigan, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Arthritis & Rheumatology Institute - Allen
Allen, Texas, United States
Tekton Research, Inc - West Gate Boulevard
Austin, Texas, United States
Centro Medico Reumatologico - OMI
CABA, Argentina
Mautalen- Salud e Investigacion
CABA, Argentina
Instituto de Investigación Clínica TyT
CABA, Argentina
Sanatorio Maipú
Maipú, Argentina
Instituto de Investigaciones Clínicas de Quilmes
Quilmes, Argentina
Sanatorio de la Mujer
Rosario, Argentina
Royal Adelaide Hospital
Adelaide, South Australia, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Medizinische Universitaet Innsbruck
Innsbruck, Austria
Ordensklinikum Linz GmbH
Linz, Austria
ULB Hopital Erasme
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium
CHU UCL Namur
Yvoir, Belgium
SAPIENS - Instituto de Estudos e Pesquisa Clínica
Curitiba, Brazil
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
Hospital das Clínicas da Universidade Federal de Pernambuco
Recife, Brazil
Hospital Mater Dei BA
Salvador, Brazil
Fundação Oswaldo Ramos (Hospital do Rim)
São Paulo, Brazil
Azidus Centro de Pesquisa Clinica Avancada
Valinhos, Brazil
Military medical academy - MHAT Pleven
Pleven, Bulgaria
Diagnostic Consultative Center Alexandrovska
Sofia, Bulgaria
CaRe Clinic (Calgary)
Calgary, Alberta, Canada
St. Joseph's Health Care (London, Ontario)
London, Ontario, Canada
The Ottawa Hospital - Riverside Campus
Ottawa, Ontario, Canada
Centro Internacional de Estudios Clínicos (CIEC)
Comuna de Recoleta, Chile
Ctr Estudios
Providencia, Chile
China-Japan Friendship Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
Xiangya Hospital, Central South University
Changsha, China
The Second Xiangya Hospital Of Central South University
Changsha, China
West China Hospital, Sichuan University
Chengdu, China
Guangdong Provincial People's Hospital
Guangzhou, China
The third affiliated hospital of Sun Yat-Sen University
Guangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Anhui Provincial Hospital
Hefei, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Nanjing Drum Tower Hospital
Nanjing, China
The First Affiliated Hospital of Ningbo University
Ningbo, China
Huashan Hospital, Fudan University
Shanghai, China
Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
Shanghai, China
The Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, China
People's Hospital of Sichuan Province
Sichuan, China
Tianjin Medical University General Hospital
Tianjin, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, China
First Affiliated Hospital of Xiamen University
Xiamen, China
Affiliated Hospital, Xuzhou Medical college
Xuzhou, China
Zhuzhou Central Hospital
Zhuzhou, China
CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas)
Bogotá, Colombia
Hospital Universitario San Ignacio de Bogotá
Bogotá, Colombia
Corporación Hospitalaria Juan Ciudad, Sede denominada Méderi
Bogotá, Colombia
Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana
Medellín, Colombia
University Hospital Centre Osijek
Osijek, Croatia
Specialty Hospital Medico
Rijeka, Croatia
Solmed Polyclinic
Zagreb, Croatia
University Hospital Brno
Brno, Czechia
Revmatologicky Ustav
Prague, Czechia
Rigshospitalet Copenhagen
Copenhagen, Denmark
Odense University Hospital
Odense C, Denmark
East Tallinn Central Hospital
Tallinn, Estonia
North Estonia Medical Centre Foundation, Tallinn
Tallinn, Estonia
Tartu University Hospital
Tartu, Estonia
Helsinki University Hospital
Helsinki, Finland
Northern Clinical Trial Coordinators
Oulu, Finland
Turku University Hospital / TYKS
Turku, Finland
HOP Pellegrin
Bordeaux, France
HOP de la Cavale Blanche
Brest, France
HOP CHU Caen
Caen, France
HOP Annecy-Genevois
Epagny Metz-Tessy, France
Hôpital Cochin
Paris, France
HOP Sud
Rennes, France
HOP Civil
Strasbourg, France
Hôpital Rangueil - CHU de Toulouse
Toulouse, France
HOP Bretonneau
Tours, France
Emergency Cardiology Center by Academician G. Chapidze
Tbilisi, Georgia
LTD Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, Georgia
LLC Mtskheta street Clinic
Tbilisi, Georgia
Auenlandklinik Bad Bramstedt GmbH
Bad Bramstedt, Germany
Immanuel-Krankenhaus GmbH
Berlin, Germany
Technische Universität Dresden
Dresden, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
Westfälische Wilhelms-Universität Münster
Münster, Germany
Helios St. Elisabeth Klinik Oberhausen
Oberhausen, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Helios Fachklinik Vogelsang-Gommern GmbH
Vogelsang, Germany
IASO General
Athens, Greece
Univ. Gen. Hosp. of Ioannina
Ioannina, Greece
General Hospital of Thessaloniki "Ippokrateio"
Thessaloniki, Greece
Semmelweis University
Budapest, Hungary
University of Pecs
Pécs, Hungary
Meir Medical Center
Kfar Saba, Israel
Azienda Ospedaliero Universitaria delle Marche
Ancona, Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, Italy
A. O. Universitaria Careggi
Florence, Italy
Istituto Ortopedico G.Pini
Milan, Italy
Ospedale San Raffaele S.r.l.
Milan, Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, Italy
AOU Università degli Studi della Campania Luigi Vanvitelli
Naples, Italy
Fondazione Policlinico Universitario Campus Bio-medico
Roma, Italy
Fujita Health University Hospital
Aichi, Toyoake, Japan
Gifu Prefectural General Medical Center
Gifu, Gifu, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Kanazawa University Hospital
Ishikawa, Kanazawa, Japan
Kagawa University Hospital
Kagawa, Kita-gun, Japan
St. Marianna University Hospital
Kanagawa, Kawasaki, Japan
Yokohama City University Hospital
Kanagawa, Yokohama, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
Tohoku Medical and Pharmaceutical University Hospital
Miyagi, Sendai, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, Japan
Keio University Hospital
Tokyo, Shinjuku-ku, Japan
Toyama University Hospital
Toyama, Toyama, Japan
Kaunas City Policlinic
Kaunas, Lithuania
Vilnius University Hospital, Santariskiu
Vilnius, Lithuania
Hospital Selayang
Batu Caves, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Sarawak General Hospital
Kuching, Malaysia
Investigacion y Biomedicina de Chihuahua S.C.
Chihuahua City, Mexico
Mediadvance Clinical S.A.P.I de C.V.
Chihuahua City, Mexico
Hosptial General de Occidente
Jalisco, Mexico
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
Mexico City, Mexico
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
UMC Utrecht
Utrecht, Netherlands
Aotearoa Clinical Trials
Papatoetoe, Auckland, New Zealand
Waikato Hospital
Hamilton, New Zealand
Sørlandet sykehus HF Kristiansand
Kristiansand, Norway
Levanger sykehus
Levanger, Norway
Sykehuset Innlandet Lillehammer
Lillehammer, Norway
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, Norway
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, Norway
Manila Doctors Hospital
Manila, Philippines
Ospital ng Makati
Metro Manil, Philippines
Philippine General Hospital
Taft, Manila, Philippines
University Clinical Hospital in Bialystok I
Bialystok, Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Bydgoszcz, Poland
Malopolskie Badania Kliniczne
Krakow, Poland
Medical Center Hetmanska
Poznan, Poland
Medicover Integrated Clinical Services Sp. z o.o.
Warsaw, Poland
ULS de Almada -Seixal, E. P. E. - Hospital Garcia de Orta
Almada, Portugal
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, Portugal
ULS de Santa Maria, E.P.E
Lisbon, Portugal
ULSAM, EPE - Hospital Conde de Bertiandos
Ponte de Lima, Portugal
Centro Hospitalar Universitário São João,EPE
Porto, Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Porto, Portugal
Delta Health Care
Bucharest, Romania
S.C. Policlinica CCBR S.R.L.
Bucharest, Romania
Spitalul Clinic Judetean de urgenta Cluj
Cluj-Napoca, Romania
Aqua Clinic (AquaMed Consulting SRL- juridic)
Constanța, Romania
National University Hospital
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Kyung Hee University Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Soonchunhyang University Hospital Seoul
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Universitario de Cruces
Barakaldo, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Spain
Hospital Juan Ramón Jimenez
Huelva, Spain
Hospital Universitari de Bellvitge
L'Hospitalet Del Llobregat, Spain
Hospital Universitario Ramon Y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
CS Parc Taulí
Sabadell, Spain
Hospital Dr. Peset
Valencia, Spain
Karolinska Universitetssjukhuset
Stockholm, Sweden
HOCH Health Ostschweiz
Sankt Gallen, Switzerland
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkoknoi, Thailand
Srinagarind Hospital
Khon Kaen, Thailand
108 Military Central Hospital
Hà Nội, Vietnam
University Medical Center HCMC
Ho Chi Minh City, Vietnam