A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
Start Date
7/27/2026
Completion Date
3/17/2030
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Placebo matching nerandomilast formulation 1
Placebo matching nerandomilast formulation 2
Nerandomilast formulation 1
Nerandomilast formulation 2
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Banner - University Medicine Rheumatology Clinic
Phoenix, Arizona 85006
United States
Arizona Arthritis and Rheumatology Associates - Paradise Valley
Scottsdale, Arizona 85032
United States
University of California Los Angeles
Los Angeles, California 90095
United States
Paradigm Clinical Research - San Diego
San Diego, California 92108
United States
Stanford University School of Medicine
Stanford, California 94305
United States
Medvin Clinical Research-Whittier-69033
Whittier, California 90602
United States
University of Colorado Denver
Aurora, Colorado 80045
United States
Georgetown University
Washington D.C., District of Columbia 20007
United States
Millennium Research - Ormond Beach
Ormond Beach, Florida 32174
United States
Integral Rheumatology and Immunology Specialist
Plantation, Florida 33324
United States
BioResearch Partner - South Miami
South Miami, Florida 33143
United States
Northwestern University
Chicago, Illinois 60611
United States
The University of Chicago Medical Center
Chicago, Illinois 60637
United States
DelRicht Research-New Orleans-64100
New Orleans, Louisiana 70115
United States
Johns Hopkins Hospital
Baltimore, Maryland 21224
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Clinical Research Institute of Michigan, LLC - St. Clair Shores
Saint Clair Shores, Michigan 48081
United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901
United States
Hospital for Special Surgery
New York, New York 10021
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York 10032
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
West Tennessee Research Institute
Jackson, Tennessee 38305
United States
Arthritis & Rheumatology Institute - Allen
Allen, Texas 75013
United States
Tekton Research, Inc - West Gate Boulevard
Austin, Texas 78745
United States
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States
Centro Medico Reumatologico - OMI
CABA, 1015
Argentina
Mautalen- Salud e Investigacion
CABA, C1128AAF
Argentina
Instituto de Investigación Clínica TyT
CABA, C1405BFN
Argentina
Sanatorio Maipú
Maipu, M5515DQA
Argentina
Instituto de Investigaciones Clínicas de Quilmes
Quilmes, B1878GEG
Argentina
Sanatorio de la Mujer
Rosario, S2000ORE
Argentina
Royal Adelaide Hospital
Adelaide, South Australia 5000
Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria 3065
Australia
Medizinische Universitaet Innsbruck
Innsbruck, 6020
Austria
Ordensklinikum Linz GmbH
Linz, 4020
Austria
Hopital Erasme
Brussels, 1070
Belgium
Universitair Ziekenhuis Gent
Ghent, 9000
Belgium
Universitair Ziekenhuis Brussel
Jette, 1090
Belgium
UZ Leuven
Leuven, 3000
Belgium
Centre Hospitalier Universitaire de Liège
Liège, 4000
Belgium
CHU UCL Namur
Yvoir, 5530
Belgium
SAPIENS - Instituto de Estudos e Pesquisa Clínica
Curitiba, 80810-000
Brazil
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90035-074
Brazil
Hospital das Clínicas da Universidade Federal de Pernambuco
Recife, 50740900
Brazil
Hospital Mater Dei BA
Salvador, 40221-500
Brazil
Fundacao Oswaldo Ramos (Hospital do Rim)
São Paulo, 04038-002
Brazil
Azidus Centro de Pesquisa Clinica Avancada
Valinhos, 13271-130
Brazil
Military medical academy - MHAT Pleven
Pleven, 5800
Bulgaria
UMHAT Pulmed OOD
Plovdiv, 4002
Bulgaria
Diagnostic Consultative Center Alexandrovska
Sofia, 1431
Bulgaria
CaRe Clinic (Calgary)
Calgary, Alberta T2N 4L7
Canada
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta T6G 1Z1
Canada
St. Joseph's Health Care (London, Ontario)
London, Ontario N6A 4V2
Canada
Centro Internacional de Estudios Clínicos (CIEC)
Comuna de Recoleta, 8420383
Chile
Ctr Estudios
Providencia, 7500571
Chile
China-Japan Friendship Hospital
Beijing, 100029
China
Peking University First Hospital
Beijing, 100034
China
Peking Union Medical College Hospital
Beijing, 100730
China
The First Hospital of Jilin University
Changchun, 130021
China
Xiangya Hospital, Central South University
Changsha, 410008
China
The Second Xiangya Hospital Of Central South University
Changsha, 410011
China
West China Hospital, Sichuan University
Chengdu, 610041
China
Guangdong Provincial People's Hospital
Guangzhou, 510080
China
The third affiliated hospital of Sun Yat-Sen University
Guangzhou, 510630
China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009
China
Anhui Provincial Hospital
Hefei, 230001
China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471003
China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
China
Nanjing Drum Tower Hospital
Nanjing, 210008
China
The First Affiliated Hospital of Ningbo University
Ningbo, 315010
China
Huashan Hospital, Fudan University
Shanghai, 200040
China
Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
Shanghai, 201112
China
The Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, 518033
China
People's Hospital of Sichuan Province
Sichuan, 610031
China
Tianjin Medical University General Hospital
Tianjin, 30052
China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
China
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, 430030
China
First Affiliated Hospital of Xiamen University
Xiamen, 361003
China
Affiliated Hospital, Xuzhou Medical college
Xuzhou, 221006
China
Zhuzhou Central Hospital
Zhuzhou, 412007
China
CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas)
Bogotá, 110231
Colombia
Hospital Universitario San Ignacio de Bogotá
Bogotá, 110231
Colombia
Corporación Hospitalaria Juan Ciudad, Sede denominada Méderi
Bogotá, 111411
Colombia
Fundación Clínica Universitaria Bolivariana
Medellín, 50034
Colombia
Klinicki Bolnicki Centar Osijek
Osijek, 31000
Croatia
Specijalna Bolnica Medico
Rijeka, 51000
Croatia
Solmed Polyclinic
Zagreb, 10000
Croatia
University Hospital Brno
Brno, 625 00
Czechia
Revmatologicky Ustav
Prague, 12800
Czechia
Rigshospitalet Copenhagen
Copenhagen, 2100
Denmark
Odense University Hospital
Odense C, 5000
Denmark
East Tallinn Central Hospital
Tallinn, 11312
Estonia
North Estonia Medical Centre Foundation, Tallinn
Tallinn, 13419
Estonia
Tartu University Hospital
Tartu, 50406
Estonia
Helsinki University Hospital
Helsinki, 00290
Finland
Northern Clinical Trial Coordinators
Oulu, 90150
Finland
Turku University Hospital / TYKS
Turku, 20520
Finland
HOP Pellegrin
Bordeaux, 33076
France
HOP de la Cavale Blanche
Brest, 29200
France
HOP CHU Caen
Caen, 14000
France
HOP Annecy-Genevois
Epagny Metz-Tessy, 74370
France
Centre Hospitalier Universitaire De Nantes
Nantes, 44093
France
Hôpital Cochin
Paris, 75014
France
HOP Sud
Rennes, 35000
France
HOP Civil
Strasbourg, 67091
France
Hôpital Rangueil - CHU de Toulouse
Toulouse, 31000
France
HOP Bretonneau
Tours, 37044
France
Emergency Cardiology Center by Academician G. Chapidze
Tbilisi, 0159
Georgia
LTD Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, 112
Georgia
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 141
Georgia
LLC Mtskheta street Clinic
Tbilisi, 179
Georgia
Auenlandklinik Bad Bramstedt GmbH
Bad Bramstedt, 24576
Germany
Immanuel-Krankenhaus GmbH
Berlin, 13125
Germany
Technische Universität Dresden
Dresden,
Germany
Medizinische Hochschule Hannover
Hanover, 30625
Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120
Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
Germany
Westfälische Wilhelms-Universität Münster
Münster,
Germany
Helios St. Elisabeth Klinik Oberhausen
Oberhausen, 46045
Germany
Universitätsklinikum Tübingen
Tübingen, 72076
Germany
Helios Fachklinik Vogelsang-Gommern GmbH
Vogelsang, 39245
Germany
IASO General
Athens, 151 23
Greece
Univ. Gen. Hosp. of Ioannina
Ioannina, 45 500
Greece
General Hospital of Thessaloniki "Ippokrateio"
Thessaloniki, 546 42
Greece
Semmelweis University
Budapest, 1023
Hungary
University of Pecs
Pécs, 7634
Hungary
St John's Medical College
Bangalore, 560034
India
AIIMS Bhubaneshwar
Bhubaneswar, 751019
India
Medanta- The Medicity
Gurugram, 122001
India
Nizam's Institute of Medical Sciences
Hyderabad, 500082
India
Care hospital
Kochi, 682040
India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Maharashtra, 400053
India
AIIMS, New Delhi
New Delhi, 110029
India
Meir Medical Center
Kfar Saba, 44281
Israel
Sheba MC
Ramat Gan, 52621
Israel
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60123
Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, 70124
Italy
A. O. Universitaria Careggi
Florence, 50134
Italy
Istituto Ortopedico G.Pini
Milan, 20122
Italy
Ospedale San Raffaele S.r.l.
Milan, 20132
Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, 41124
Italy
AOU Università degli Studi della Campania Luigi Vanvitelli
Naples, 80131
Italy
Fondazione Policlinico Universitario Campus Bio-medico
Roma, 00128
Italy
Japan Community Healthcare Organization Chukyo Hospital
Aichi, Nagoya, 457-8510
Japan
Fujita Health University Hospital
Aichi, Toyoake, 470-1192
Japan
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556
Japan
Gifu Prefectural General Medical Center
Gifu, Gifu, 500-8717
Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Japan
Sapporo Medical University Hospital
Hokkaido, Sapporo, 060-8543
Japan
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
Japan
Kanazawa University Hospital
Ishikawa, Kanazawa, 920-8641
Japan
Kagawa University Hospital
Kagawa, Kita-gun, 761-0793
Japan
St. Marianna University Hospital
Kanagawa, Kawasaki, 216-8511
Japan
Kitasato University Hospital
Kanagawa, Sagamihara, 252-0375
Japan
Yokohama City University Hospital
Kanagawa, Yokohama, 236-0004
Japan
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Japan
Tohoku Medical and Pharmaceutical University Hospital
Miyagi, Sendai, 983-8512
Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501
Japan
Osaka Medical and Pharmaceutical University Hospital
Osaka, Takatsuki, 569-8686
Japan
Saitama Medical University Hospital
Saitama, Iruma-gun, 350-0495
Japan
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, 113-8603
Japan
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582
Japan
Toyama University Hospital
Toyama, Toyama, 930-0194
Japan
Kaunas City Policlinic
Kaunas, 51270
Lithuania
Vilnius University Hospital, Santariskiu
Vilnius, 08406
Lithuania
Hospital Selayang
Batu Caves, 68100
Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100
Malaysia
Sarawak General Hospital
Kuching, 93586
Malaysia
Investigacion y Biomedicina de Chihuahua S.C.
Chihuahua City, 31020
Mexico
Mediadvance Clinical S.A.P.I de C.V.
Chihuahua City, 31203
Mexico
Centro Integral en Reumatologia, SA. de CV.
Guadalajara, 44160
Mexico
Hosptial General de Occidente
Jalisco, 45170
Mexico
Centro de Investigacion Farmacologica del Bajío, S.C.
León, 37160
Mexico
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
Mexico City, 06700
Mexico
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
Mexico
Clinical Research Institute S.C.
Tlalnepantla, 54055
Mexico
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Netherlands
Aotearoa Clinical Trials
Auckland, 2025
New Zealand
Waikato Hospital
Hamilton, 3240
New Zealand
Sørlandet sykehus HF Kristiansand
Kristiansand, 4615
Norway
Levanger sykehus
Levanger, 7600
Norway
Sykehuset Innlandet Lillehammer
Lillehammer, 2609
Norway
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, 0372
Norway
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, 4011
Norway
Manila Doctors Hospital
Manila, 1000
Philippines
Ospital ng Makati
Metro Manil, 1218
Philippines
Philippine General Hospital
Taft, Manila, 1000
Philippines
University Clinical Hospital in Bialystok I
Bialystok, 15-276
Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Bydgoszcz, 85-168
Poland
Malopolskie Badania Kliniczne
Krakow, 30-002
Poland
Medical Center Hetmanska
Poznan, 60-218
Poland
Medicover Integrated Clinical Services Sp. z o.o.
Warsaw, 00874
Poland
ULS de Almada -Seixal, E. P. E. - Hospital Garcia de Orta
Almada, 2801-951
Portugal
CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, 3004-561
Portugal
ULS de Santa Maria, E.P.E
Lisbon, 1649-035
Portugal
ULSAM, EPE - Hospital Conde de Bertiandos
Ponte de Lima, 4990-041
Portugal
Centro Hospitalar Universitário São João,EPE
Porto, 4200-319
Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Porto, 4434-502
Portugal
Delta Health Care
Bucharest, 014142
Romania
S.C. Policlinica CCBR S.R.L.
Bucharest, 030463
Romania
Spitalul Clinic Judetean de urgenta Cluj
Cluj-Napoca, 400006
Romania
Aqua Clinic (AquaMed Consulting SRL- juridic)
Constanța, 900622
Romania
National University Hospital
Singapore, 119074
Singapore
Singapore General Hospital
Singapore, 169608
Singapore
Mediclinic Winelands Orthopaedic Hospital
Stellenbosch, 7599
South Africa
Kyung Hee University Hospital
Seoul, 02447
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Soonchunhyang University Hospital Seoul
Seoul, 04401
South Korea
Ajou University Hospital
Suwon, 16499
South Korea
Hospital Germans Trias i Pujol
Badalona, 08916
Spain
Hospital Universitario de Cruces
Barakaldo, 48903
Spain
Hospital del Mar
Barcelona, 08003
Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital Santa Creu i Sant Pau
Barcelona, 08041
Spain
Hospital Juan Ramón Jimenez
Huelva, 21005
Spain
Hospital Universitari de Bellvitge
L'Hospitalet Del Llobregat, 08907
Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
CS Parc Taulí
Sabadell, 08208
Spain
Hospital Dr. Peset
Valencia, 46017
Spain
Karolinska Universitetssjukhuset
Stockholm, 171 76
Sweden
HOCH Health Ostschweiz
Sankt Gallen, 9007
Switzerland
China Medical University Hospital
Taichung, 404
Taiwan
Taichung Veterans General Hospital
Taichung, 40705
Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Thailand
Ramathibodi Hospital
Bangkok, 10400
Thailand
Siriraj Hospital
Bangkoknoi, 10700
Thailand
Srinagarind Hospital
Khon Kaen, 40002
Thailand
Southmead Hospital
Bristol, BS10 5NB
United Kingdom
Chapel Allerton Hospital
Leeds, LS7 4SA
United Kingdom
Royal Free Hospital
London, NW3 2QG
United Kingdom
Salford Royal
Salford, M6 8HD
United Kingdom
Bach Mai hospital
Hanoi, 100000
Vietnam
University Medical Center HCMC
Ho Chi Minh City, 70000
Vietnam