A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis (VERANDA™-SSc)

August 19, 2026 updated by: Boehringer Ingelheim

A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

448

Phase

  • Phase 3

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
      • CABA, Argentina, C1128AAF
      • CABA, Argentina, 1015
      • CABA, Argentina, C1405BFN
        • Recruiting
        • Instituto de Investigacion Clinica TyT
        • Contact:
      • Maipu, Argentina, M5515DQA
      • Quilmes, Argentina, B1878GEG
        • Recruiting
        • Instituto de Investigaciones Clinicas de Quilmes
        • Contact:
      • Rosario, Argentina, S2000ORE
  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Not yet recruiting
        • St Vincent's Hospital Melbourne
        • Contact:
  • Austria
      • Innsbruck, Austria, 6020
      • Linz, Austria, 4020
  • Belgium
      • Brussels, Belgium, 1070
      • Ghent, Belgium, 9000
        • Not yet recruiting
        • Universitair Ziekenhuis Gent
        • Contact:
      • Jette, Belgium, 1090
        • Not yet recruiting
        • Universitair Ziekenhuis Brussel
        • Contact:
      • Leuven, Belgium, 3000
      • Liège, Belgium, 4000
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Liège
        • Contact:
      • Yvoir, Belgium, 5530
  • Brazil
      • Curitiba, Brazil, 80810-000
        • Not yet recruiting
        • SAPIENS - Instituto de Estudos e Pesquisa Clínica
        • Contact:
      • Porto Alegre, Brazil, 90035-074
        • Not yet recruiting
        • Santa Casa de Misericordia de Porto Alegre
        • Contact:
      • Recife, Brazil, 50740900
        • Not yet recruiting
        • Hospital das Clínicas da Universidade Federal de Pernambuco
        • Contact:
      • Salvador, Brazil, 40221-500
        • Not yet recruiting
        • Hospital Mater Dei BA
        • Contact:
      • São Paulo, Brazil, 04038-002
        • Recruiting
        • Fundacao Oswaldo Ramos (Hospital do Rim)
        • Contact:
      • Valinhos, Brazil, 13271-130
        • Recruiting
        • Azidus Centro de Pesquisa Clinica Avancada
        • Contact:
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Not yet recruiting
        • Military medical academy - MHAT Pleven
        • Contact:
      • Plovdiv, Bulgaria, 4002
      • Sofia, Bulgaria, 1431
        • Not yet recruiting
        • Diagnostic Consultative Center Alexandrovska
        • Contact:
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4L7
        • Not yet recruiting
        • CaRe Clinic (Calgary)
        • Contact:
      • Edmonton, Alberta, Canada, T6G 1Z1
        • Not yet recruiting
        • University of Alberta Hospital (University of Alberta)
        • Contact:
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Not yet recruiting
        • St. Joseph's Health Care (London, Ontario)
        • Contact:
  • Chile
      • Comuna de Recoleta, Chile, 8420383
        • Not yet recruiting
        • Centro Internacional de Estudios Clinicos (CIEC)
        • Contact:
      • Providencia, Chile, 7500571
  • China
      • Beijing, China, 100730
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, China, 100034
        • Not yet recruiting
        • Peking University First Hospital
        • Contact:
      • Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
      • Changchun, China, 130021
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changsha, China, 410011
        • Not yet recruiting
        • The second Xiangya Hospital of Central South University
        • Contact:
      • Changsha, China, 410008
        • Not yet recruiting
        • Xiangya Hospital, Central South University
        • Contact:
      • Chengdu, China, 610041
        • Not yet recruiting
        • West China Hospital, Sichuan University
        • Contact:
      • Guangzhou, China, 510080
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guangzhou, China, 510630
        • Not yet recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
      • Hangzhou, China, 310009
        • Not yet recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hefei, China, 230001
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Contact:
      • Luoyang, China, 471003
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of science and Technology
        • Contact:
      • Nanchang, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
      • Nanjing, China, 210008
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Ningbo, China, 315010
        • Not yet recruiting
        • The First Affiliated Hospital of Ningbo University
        • Contact:
      • Shanghai, China, 200040
        • Not yet recruiting
        • Huashan Hospital, Fudan University
        • Contact:
      • Shanghai, China, 201112
        • Not yet recruiting
        • Renji Hospital Shanghai Jiaotong University School of Medicine
        • Contact:
      • Shenzhen, China, 518033
        • Not yet recruiting
        • The Eighth Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Sichuan, China, 610031
        • Not yet recruiting
        • People's Hospital of Sichuan Province
        • Contact:
      • Tianjin, China, 30052
        • Not yet recruiting
        • Tianjin Medical University General Hospital
        • Contact:
      • Wenzhou, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
      • Wuhan, China, 430030
        • Not yet recruiting
        • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
        • Contact:
      • Xiamen, China, 361003
        • Not yet recruiting
        • First Affiliated Hospital of Xiamen University
        • Contact:
      • Xuzhou, China, 221006
        • Not yet recruiting
        • The Affiliated Hospital of Xuzhou Medical College
        • Contact:
      • Zhuzhou, China, 412007
        • Not yet recruiting
        • ZhuZhou Central Hospital
        • Contact:
  • Colombia
      • Bogotá, Colombia, 110231
        • Not yet recruiting
        • CIREEM SAS (Centro de Investigacion en Reumatologia y Especialidades Medicas)
        • Contact:
      • Bogotá, Colombia, 110231
        • Not yet recruiting
        • Hospital Universitario San Ignacio de Bogota
        • Contact:
      • Bogotá, Colombia, 111411
        • Not yet recruiting
        • Corporacion Hospitalaria Juan Ciudad, Sede denominada Mederi
        • Contact:
      • Medellín, Colombia, 50034
        • Not yet recruiting
        • Fundacion Clinica Universitaria Bolivariana
        • Contact:
  • Croatia
      • Osijek, Croatia, 31000
        • Not yet recruiting
        • Klinicki bolnicki centar Osijek
        • Contact:
      • Rijeka, Croatia, 51000
      • Zagreb, Croatia, 10000
  • Czechia
      • Brno, Czechia, 625 00
        • Not yet recruiting
        • University Hospital Brno
        • Contact:
      • Prague, Czechia, 12800
        • Not yet recruiting
        • Revmatologicky ustav
        • Contact:
  • Denmark
      • Copenhagen, Denmark, 2100
        • Not yet recruiting
        • Rigshospitalet Copenhagen
        • Contact:
      • Odense C, Denmark, 5000
        • Not yet recruiting
        • Odense University Hospital
        • Contact:
  • Estonia
      • Tallinn, Estonia, 13419
        • Not yet recruiting
        • North Estonia Medical Centre Foundation, Tallinn
        • Contact:
      • Tallinn, Estonia, 11312
        • Not yet recruiting
        • East Tallinn Central Hospital
        • Contact:
      • Tartu, Estonia, 50406
        • Not yet recruiting
        • Tartu University Hospital
        • Contact:
  • Finland
      • Helsinki, Finland, 00290
        • Not yet recruiting
        • Helsinki University Hospital
        • Contact:
      • Oulu, Finland, 90150
        • Not yet recruiting
        • Northern Clinical Trial Coordinators
        • Contact:
      • Turku, Finland, 20520
        • Not yet recruiting
        • Turku University Hospital / TYKS
        • Contact:
  • France
      • Bordeaux, France, 33076
      • Brest, France, 29200
        • Not yet recruiting
        • HOP de la Cavale Blanche
        • Contact:
      • Caen, France, 14000
      • Epagny Metz-Tessy, France, 74370
        • Not yet recruiting
        • HOP Annecy-Genevois
        • Contact:
      • Nantes, France, 44093
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Nantes
        • Contact:
      • Paris, France, 75014
      • Rennes, France, 35000
      • Strasbourg, France, 67091
      • Toulouse, France, 31000
        • Not yet recruiting
        • Hôpital Rangueil - CHU de Toulouse
        • Contact:
      • Tours, France, 37044
  • Georgia
      • Tbilisi, Georgia, 112
        • Not yet recruiting
        • LTD Israeli-Georgian Medical Research Clinic Healthycore
        • Contact:
      • Tbilisi, Georgia, 0159
        • Not yet recruiting
        • Emergency Cardiology Center by Academician G. Chapidze
        • Contact:
      • Tbilisi, Georgia, 141
        • Not yet recruiting
        • LEPL The First University Clinic of Tbilisi State Medical University
        • Contact:
      • Tbilisi, Georgia, 179
  • Germany
      • Bad Bramstedt, Germany, 24576
      • Berlin, Germany, 13125
      • Dresden, Germany
      • Freiburg im Breisgau, Germany, 79106
      • Hanover, Germany, 30625
      • Heidelberg, Germany, 69120
      • Lübeck, Germany, 23538
        • Not yet recruiting
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
        • Contact:
      • Münster, Germany
        • Not yet recruiting
        • Westfälische Wilhelms-Universität Münster
        • Contact:
      • Oberhausen, Germany, 46045
        • Not yet recruiting
        • Helios St. Elisabeth Klinik Oberhausen
        • Contact:
      • Tübingen, Germany, 72076
      • Vogelsang, Germany, 39245
        • Not yet recruiting
        • Helios Fachklinik Vogelsang-Gommern GmbH
        • Contact:
  • Greece
      • Athens, Greece, 151 23
      • Ioannina, Greece, 45 500
        • Not yet recruiting
        • Univ. Gen. Hosp. of Ioannina
        • Contact:
      • Thessaloniki, Greece, 546 42
        • Not yet recruiting
        • General Hospital of Thessaloniki "Ippokrateio"
        • Contact:
  • Hungary
      • Budapest, Hungary, 1023
      • Debrecen, Hungary, 4032
      • Pécs, Hungary, 7634
  • India
      • Bangalore, India, 560034
        • Not yet recruiting
        • St John's Medical College
        • Contact:
      • Bhubaneswar, India, 751019
        • Not yet recruiting
        • AIIMS Bhubaneshwar
        • Contact:
      • Gurugram, India, 122001
        • Not yet recruiting
        • Medanta- The Medicity
        • Contact:
      • Hyderabad, India, 500082
        • Not yet recruiting
        • Nizam's Institute of Medical Sciences
        • Contact:
      • Kochi, India, 682040
        • Not yet recruiting
        • Care hospital
        • Contact:
      • Maharashtra, India, 400053
        • Not yet recruiting
        • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
        • Contact:
      • New Delhi, India, 110029
        • Not yet recruiting
        • AIIMS, New Delhi
        • Contact:
  • Israel
      • Haifa, Israel, 3109601
        • Not yet recruiting
        • Rambam Health Care Campus
        • Contact:
      • Haifa, Israel, 31048
        • Not yet recruiting
        • Bnai Zion Medical Center, Haifa
        • Contact:
      • Kfar Saba, Israel, 44281
        • Not yet recruiting
        • Meir Medical Center
        • Contact:
      • Ramat Gan, Israel, 52621
  • Italy
      • Ancona, Italy, 60123
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria Delle Marche
        • Contact:
      • Bari, Italy, 70124
        • Not yet recruiting
        • Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
        • Contact:
      • Florence, Italy, 50134
        • Not yet recruiting
        • A. O. Universitaria Careggi
        • Contact:
      • Milan, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele S.r.l.
        • Contact:
      • Milan, Italy, 20122
        • Not yet recruiting
        • Istituto Ortopedico G.Pini
        • Contact:
      • Modena, Italy, 41124
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria di Modena
        • Contact:
      • Naples, Italy, 80131
        • Not yet recruiting
        • AOU Università degli Studi della Campania Luigi Vanvitelli
        • Contact:
      • Roma, Italy, 00128
        • Not yet recruiting
        • Fondazione Policlinico Universitario Campus Bio-Medico
        • Contact:
  • Japan
      • Aichi, Nagoya, Japan, 457-8510
        • Not yet recruiting
        • Japan Community Healthcare Organization Chukyo Hospital
        • Contact:
      • Aichi, Toyoake, Japan, 470-1192
        • Not yet recruiting
        • Fujita Health University Hospital
        • Contact:
      • Fukuoka, Kitakyushu, Japan, 807-8556
        • Not yet recruiting
        • Hospital of the University of Occupational and Environmental Health
        • Contact:
      • Gifu, Gifu, Japan, 500-8717
        • Not yet recruiting
        • Gifu Prefectural General Medical Center
        • Contact:
      • Hiroshima, Hiroshima, Japan, 734-8551
        • Not yet recruiting
        • Hiroshima University Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8543
        • Not yet recruiting
        • Sapporo Medical University Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8648
        • Not yet recruiting
        • Hokkaido University Hospital
        • Contact:
      • Ishikawa, Kanazawa, Japan, 920-8641
        • Not yet recruiting
        • Kanazawa University Hospital
        • Contact:
      • Kagawa, Kita-gun, Japan, 761-0793
        • Not yet recruiting
        • Kagawa University Hospital
        • Contact:
      • Kanagawa, Kawasaki, Japan, 216-8511
        • Not yet recruiting
        • St. Marianna University Hospital
        • Contact:
      • Kanagawa, Sagamihara, Japan, 252-0375
        • Not yet recruiting
        • Kitasato University Hospital
        • Contact:
      • Kanagawa, Yokohama, Japan, 236-0004
        • Not yet recruiting
        • Yokohama City University Hospital
        • Contact:
      • Kyoto, Kyoto, Japan, 606-8507
        • Not yet recruiting
        • Kyoto University Hospital
        • Contact:
      • Miyagi, Sendai, Japan, 983-8512
        • Not yet recruiting
        • Tohoku Medical and Pharmaceutical University Hospital
        • Contact:
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Not yet recruiting
        • Nagasaki University Hospital
        • Contact:
      • Osaka, Takatsuki, Japan, 569-8686
        • Not yet recruiting
        • Osaka Medical and Pharmaceutical University Hospital
        • Contact:
      • Saitama, Iruma-gun, Japan, 350-0495
        • Not yet recruiting
        • Saitama Medical University Hospital
        • Contact:
      • Tokyo, Bunkyo-ku, Japan, 113-8603
        • Not yet recruiting
        • Nippon Medical School Hospital
        • Contact:
      • Tokyo, Shinjuku-ku, Japan, 160-8582
        • Not yet recruiting
        • Keio University Hospital
        • Contact:
      • Toyama, Toyama, Japan, 930-0194
        • Not yet recruiting
        • Toyama University Hospital
        • Contact:
  • Lithuania
      • Kaunas, Lithuania, 51270
      • Vilnius, Lithuania, 08406
        • Not yet recruiting
        • Vilnius University Hospital, Santariskiu
        • Contact:
  • Malaysia
      • Batu Caves, Malaysia, 68100
      • Kuala Lumpur, Malaysia, 59100
        • Not yet recruiting
        • University Malaya Medical Centre
        • Contact:
      • Kuching, Malaysia, 93586
        • Not yet recruiting
        • Sarawak General Hospital
        • Contact:
  • Mexico
      • Chihuahua City, Mexico, 31203
        • Not yet recruiting
        • Mediadvance Clinical S.A.P.I de C.V.
        • Contact:
      • Chihuahua City, Mexico, 31020
        • Not yet recruiting
        • Investigacion y Biomedicina de Chihuahua S.C.
        • Contact:
      • Guadalajara, Mexico, 44160
        • Not yet recruiting
        • Centro Integral en Reumatologia, SA. de CV.
        • Contact:
      • Jalisco, Mexico, 45170
        • Not yet recruiting
        • Hosptial General de Occidente
        • Contact:
      • León, Mexico, 37160
        • Not yet recruiting
        • Centro de Investigacion Farmacologica del Bajío, S.C.
        • Contact:
      • Mexico City, Mexico, 06700
        • Not yet recruiting
        • CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
        • Contact:
      • Mexico City, Mexico, 14080
        • Not yet recruiting
        • Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contact:
      • Tlalnepantla, Mexico, 54055
        • Not yet recruiting
        • Clinical Research Institute S.C.
        • Contact:
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Not yet recruiting
        • Universitair Medisch Centrum Groningen
        • Contact:
      • Nijmegen, Netherlands, 6525 GA
        • Not yet recruiting
        • Radboud Universitair Medisch Centrum
        • Contact:
      • Rotterdam, Netherlands, 3015 GD
  • New Zealand
      • Auckland, New Zealand, 2025
      • Hamilton, New Zealand, 3240
  • Norway
      • Kristiansand, Norway, 4615
        • Not yet recruiting
        • Sørlandet sykehus HF Kristiansand
        • Contact:
      • Levanger, Norway, 7600
        • Not yet recruiting
        • Levanger sykehus
        • Contact:
      • Lillehammer, Norway, 2609
        • Not yet recruiting
        • Sykehuset Innlandet Lillehammer
        • Contact:
      • Oslo, Norway, 0372
        • Not yet recruiting
        • Oslo universitetssykehus HF, Rikshospitalet
        • Contact:
      • Stavanger, Norway, 4011
        • Not yet recruiting
        • Helse Stavanger, Stavanger Universitetssykehus
        • Contact:
  • Philippines
      • Manila, Philippines, 1000
      • Metro Manil, Philippines, 1218
      • Taft, Manila, Philippines, 1000
        • Not yet recruiting
        • Philippine General Hospital
        • Contact:
  • Poland
      • Bialystok, Poland, 15-276
        • Not yet recruiting
        • University Clinical Hospital in Bialystok I
        • Contact:
      • Bydgoszcz, Poland, 85-168
        • Not yet recruiting
        • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
        • Contact:
      • Krakow, Poland, 30-002
        • Not yet recruiting
        • Malopolskie Badania Kliniczne
        • Contact:
      • Poznan, Poland, 60-218
        • Not yet recruiting
        • Medical Center Hetmanska
        • Contact:
      • Warsaw, Poland, 00874
        • Not yet recruiting
        • Medicover Integrated Clinical Services Sp. z o.o.
        • Contact:
  • Portugal
      • Almada, Portugal, 2801-951
        • Not yet recruiting
        • ULS de Almada -Seixal, E. P. E. - Hospital Garcia de Orta
        • Contact:
      • Coimbra, Portugal, 3004-561
        • Not yet recruiting
        • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
        • Contact:
      • Lisbon, Portugal, 1649-035
        • Not yet recruiting
        • ULS de Santa Maria, E.P.E
        • Contact:
      • Ponte de Lima, Portugal, 4990-041
        • Not yet recruiting
        • ULSAM, EPE - Hospital Conde de Bertiandos
        • Contact:
      • Porto, Portugal, 4200-319
        • Not yet recruiting
        • Centro Hospitalar Universitário São João,EPE
        • Contact:
      • Porto, Portugal, 4434-502
        • Not yet recruiting
        • Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
        • Contact:
  • Romania
      • Bucharest, Romania, 030463
        • Not yet recruiting
        • S.C. Policlinica CCBR S.R.L.
        • Contact:
      • Bucharest, Romania, 014142
      • Cluj-Napoca, Romania, 400006
        • Not yet recruiting
        • Spitalul Clinic Judetean de urgenta Cluj
        • Contact:
      • Constanța, Romania, 900622
        • Not yet recruiting
        • Aqua Clinic (AquaMed Consulting SRL- juridic)
        • Contact:
  • Singapore
      • Singapore, Singapore, 169608
      • Singapore, Singapore, 119074
        • Not yet recruiting
        • National University Hospital
        • Contact:
  • South Africa
      • Stellenbosch, South Africa, 7599
        • Not yet recruiting
        • Mediclinic Winelands Orthopaedic Hospital
        • Contact:
  • South Korea
      • Seoul, South Korea, 03080
        • Not yet recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea, 02447
        • Not yet recruiting
        • Kyung Hee University Hospital
        • Contact:
      • Seoul, South Korea, 04401
        • Not yet recruiting
        • Soonchunhyang University Hospital Seoul
        • Contact:
      • Suwon, South Korea, 16499
        • Not yet recruiting
        • Ajou University Hospital
        • Contact:
  • Spain
      • Badalona, Spain, 08916
        • Not yet recruiting
        • Hospital Germans Trias i Pujol
        • Contact:
      • Barakaldo, Spain, 48903
        • Not yet recruiting
        • Hospital Universitario de Cruces
        • Contact:
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08041
        • Not yet recruiting
        • Hospital Santa Creu i Sant Pau
        • Contact:
      • Huelva, Spain, 21005
        • Not yet recruiting
        • Hospital Juan Ramón Jimenez
        • Contact:
      • L'Hospitalet Del Llobregat, Spain, 08907
        • Not yet recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
      • Madrid, Spain, 28034
        • Not yet recruiting
        • Hospital Universitario Ramon Y Cajal
        • Contact:
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Sabadell, Spain, 08208
      • Valencia, Spain, 46017
        • Not yet recruiting
        • Hospital Dr. Peset
        • Contact:
  • Sweden
      • Stockholm, Sweden, 171 76
        • Not yet recruiting
        • Karolinska Universitetssjukhuset
        • Contact:
  • Switzerland
      • Sankt Gallen, Switzerland, 9007
        • Not yet recruiting
        • HOCH Health Ostschweiz
        • Contact:
  • Taiwan
      • Taichung, Taiwan, 40705
        • Not yet recruiting
        • Taichung Veterans General Hospital
        • Contact:
      • Taichung, Taiwan, 404
        • Not yet recruiting
        • China Medical University Hospital
        • Contact:
  • Thailand
      • Bangkok, Thailand, 10330
        • Not yet recruiting
        • King Chulalongkorn Memorial Hospital
        • Contact:
      • Bangkok, Thailand, 10400
        • Not yet recruiting
        • Ramathibodi Hospital
        • Contact:
      • Bangkoknoi, Thailand, 10700
        • Not yet recruiting
        • Siriraj Hospital
        • Contact:
      • Khon Kaen, Thailand, 40002
        • Not yet recruiting
        • Srinagarind Hospital
        • Contact:
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
      • Leeds, United Kingdom, LS7 4SA
      • London, United Kingdom, NW3 2QG
      • Salford, United Kingdom, M6 8HD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Not yet recruiting
        • Banner - University Medicine Rheumatology Clinic
        • Contact:
      • Scottsdale, Arizona, United States, 85032
        • Not yet recruiting
        • Arizona Arthritis and Rheumatology Associates - Paradise Valley
        • Contact:
    • California
      • Los Angeles, California, United States, 90095
      • San Diego, California, United States, 92108
      • Stanford, California, United States, 94305
        • Not yet recruiting
        • Stanford University School of Medicine
        • Contact:
      • Whittier, California, United States, 90602
    • Colorado
      • Aurora, Colorado, United States, 80045
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
    • Florida
      • Ormond Beach, Florida, United States, 32174
      • Plantation, Florida, United States, 33324
        • Not yet recruiting
        • Integral Rheumatology and Immunology Specialist
        • Contact:
      • South Miami, Florida, United States, 33143
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • The University of Chicago Medical Center
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
    • Maryland
      • Baltimore, Maryland, United States, 21224
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Saint Clair Shores, Michigan, United States, 48081
        • Not yet recruiting
        • Clinical Research Institute of Michigan, LLC - St. Clair Shores
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Not yet recruiting
        • M Health Fairview University of Minnesota Medical Center
        • Contact:
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Not yet recruiting
        • Rutgers Robert Wood Johnson Medical School
        • Contact:
    • New York
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
      • New York, New York, United States, 10021
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Columbia University Medical Center-New York Presbyterian Hospital
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia, Pennsylvania, United States, 19104
    • Tennessee
      • Jackson, Tennessee, United States, 38305
    • Texas
      • Allen, Texas, United States, 75013
        • Not yet recruiting
        • Arthritis & Rheumatology Institute - Allen
        • Contact:
      • Austin, Texas, United States, 78745
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Not yet recruiting
        • Bach Mai Hospital
        • Contact:
      • Ho Chi Minh City, Vietnam, 70000
        • Not yet recruiting
        • University Medical Center HCMC
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  2. Patients must be at least 18 years of age and fulfil the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) criteria for SSc.
  3. Patients must be diagnosed with limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc), as defined by LeRoy et al. (1988).
  4. Disease onset (defined by first non-RP [Raynaud's phenomenon] symptom) must be within 7 years of Visit 1.
  5. Trial participants with dcSSc must have evidence of active disease during screening.
  6. Trial participants with lcSSc must have evidence of active disease during screening. LcSSc patients must be anti-centromere antibody (ACA) negative.
  7. FVC % predicted ≥45% at Visit 1.
  8. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted ≥25% corrected for haemoglobin (Hb) at Visit 1.
  9. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control.
  10. Patients may be either untreated or on stable treatment with permitted immunosuppressive/immunomodulatory agents and/or nintedanib. All treatments must remain stable prior to Visit 2 and during the screening period

Exclusion criteria:

  1. Active, unstable, or uncontrolled vasculitis within 8 weeks prior to Visit 1 or during the screening period.
  2. Any suicidal behaviour in the past 2 years.
  3. Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months. Further exclusion criteria apply.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo matching nerandomilast formulation 1
Film-coated tablets
Drug: Placebo matching nerandomilast formulation 2
Film-coated tablets
Experimental: Nerandomilast
Drug: Nerandomilast formulation 1
Film-coated tablets
Drug: Nerandomilast formulation 2
Film-coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to the first occurrence of disease progression or all-cause death
Time Frame: up to 4 years
up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in mRSS at Week 52
Time Frame: At baseline and at Week 52.

The modified Rodnan Skin Score (mRSS) measures skin thickness and is the sum of scores from 17 surface anatomic areas rated on a 0-3 scale (0=normal skin; 1=mild thickness; 2=moderate thickness; 3=severe thickness with inability to pinch the skin into a fold).

The total mRSS ranges from 0 (best possible outcome) to 51 (worst possible outcome).
At baseline and at Week 52.
Change from baseline in HAQ-DI score at Week 52
Time Frame: At baseline and at Week 52.

Health Assessment Questionnaire Disability Index (HAQ-DI) is used frequently in rheumatological disorders including SSc, assessing function/activities of daily living with 20 items in 8 categories, namely dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities.

Each category has at least 2 sub-category questions. Within each category, patients report the amount of difficulty they have in performing the specific sub-category items.

There are four response options ranging from "no difficulty" to "unable to do", scored 0 to 3.

A global score will be calculated from the category scores with higher scores indicating more severe disability.
At baseline and at Week 52.
Change from baseline in FVC [mL] at Week 52
Time Frame: At baseline and at Week 52.
Forced vital capacity (FVC)
At baseline and at Week 52.
Disease improvement as defined by rCRISS-25 at Week 52
Time Frame: At baseline and at Week 52.

Revised composite response index in systemic sclerosis (rCRISS) is a composite outcome measure developed for SSc that includes PRO and clinician-reported outcome (ClinRO) measures:

  • mRSS
  • FVC %
  • HAQ-DI
  • Patient Global Assessment (PGA) of overall health status
  • Clinician Global Assessment (CGA) of overall health status

For rCRISS-25 a patient has improvement on at least 2 of the 5 core set measures and without worsening on more than 1 core set measure. The improvement or worsening must be at least 25% relative change from the baseline for 4 core set measures (or ≥5% relative change from baseline for FVC % predicted).
At baseline and at Week 52.
Time to first occurrence of confirmed absolute decline from baseline in FVC % predicted ≥5% (for patients with ILD at baseline) or newly diagnosed ILD (for patients without ILD at baseline) or death
Time Frame: up to 4 years
up to 4 years
Time to first occurrence of absolute increase in mRSS ≥5 points and relative increase from baseline in mRSS ≥25% or death
Time Frame: up to 4 years
up to 4 years
Time to first occurrence of adjudicated SSc-related related clinically meaningful disease progression or complication or death
Time Frame: up to 4 years
up to 4 years
Time to all-cause death
Time Frame: up to 4 years
up to 4 years
Change from baseline in Systemic Sclerosis Impact of Disease (ScleroID) score at Week 52
Time Frame: At baseline and at Week 52.

The Systemic Sclerosis Impact of Disease (ScleroID) is a patient reported outcome (PRO) measure specifically developed to assess how SSc affects a person's life.

The ScleroID has 10 items and it covers 10 domains. Every item is rated on a 0-10 numeric rating scale and the individual scores are computed using a weighted sum, resulting in a final score ranging from 0 to 10.

A higher score means a higher impact of disease.
At baseline and at Week 52.
Change from baseline in digital ulcer total burden at Week 52
Time Frame: At baseline and at Week 52.
At baseline and at Week 52.

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

July 27, 2026

Primary Completion (Estimated)

February 26, 2030

Study Completion (Estimated)

March 17, 2030

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1305-0052
  • 2025-523884-39-00 (Registry Identifier: CTIS (EU))
  • U1111-1329-6365 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor'spublication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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