RECRUITING Phase 3 ClinicalTrials.gov

A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis

Sponsor: Boehringer Ingelheim • ClinicalTrials.gov ID: NCT07497087

Registry updated: 2026-10-14

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Description

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.

Interventions

Placebo matching nerandomilast formulation 1 (Drug)
Film-coated tablets
Placebo matching nerandomilast formulation 2 (Drug)
Film-coated tablets
Nerandomilast formulation 1 (Drug)
Film-coated tablets
Nerandomilast formulation 2 (Drug)
Film-coated tablets

Eligibility criteria

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.

Conditions

Systemic Sclerosis

Locations

University of Alabama at Birmingham — Birmingham, Alabama, United States
Banner - University Medicine Rheumatology Clinic — Phoenix, Arizona, United States
Arizona Arthritis and Rheumatology Associates - Paradise Valley — Scottsdale, Arizona, United States
University of California Los Angeles — Los Angeles, California, United States
Paradigm Clinical Research - San Diego — San Diego, California, United States
Stanford University School of Medicine — Stanford, California, United States
Medvin Clinical Research-Whittier-69033 — 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
M Health Fairview University of Minnesota Medical Center — Minneapolis, Minnesota, United States
Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
Hospital for Special Surgery — New York, New York, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Columbia University Medical Center-New York Presbyterian Hospital — 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
Tekton Research, Inc - West Gate Boulevard — Austin, Texas, United States
Arthritis & Rheumatology Institute - Frisco — Frisco, Texas, United States
The University of Texas Health Science Center at Houston — Houston, Texas, United States
Centro Medico Reumatologico - OMI — CABA, Argentina
Mautalen- Salud e Investigacion — CABA, Argentina
Instituto de Investigacion Clinica TyT — CABA, Argentina
Sanatorio Maipu — Maipu, Argentina
Instituto de Investigaciones Clinicas de Quilmes — Quilmes, Argentina
Sanatorio de la Mujer — Rosario, Argentina
Westmead Hospital — Westmead, New South Wales, Australia
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
Hopital Erasme — Brussels, Belgium
Universitair Ziekenhuis Gent — Ghent, Belgium
Universitair Ziekenhuis Brussel — Jette, Belgium
UZ Leuven — Leuven, Belgium
Centre Hospitalier Universitaire de Liège — Liège, Belgium
CHU UCL Namur — Yvoir, Belgium
SAPIENS - Instituto de Estudos e Pesquisa Clinica — Curitiba, Brazil
Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Brazil
Hospital das Clinicas da Universidade Federal de Pernambuco — Recife, Brazil
Hospital Mater Dei BA — Salvador, Brazil
Fundacao Oswaldo Ramos (Hospital do Rim) — São Paulo, Brazil
A2Z Clinical Centro Avançado de Pesquisa Clinica — Valinhos, Brazil
UMHAT Pulmed OOD — Plovdiv, Bulgaria
Diagnostic Consultative Center Alexandrovska — Sofia, Bulgaria
CaRe Clinic (Calgary) — Calgary, Alberta, Canada
University of Alberta Hospital (University of Alberta) — Edmonton, Alberta, Canada
St. Joseph's Health Care (London, Ontario) — London, Ontario, Canada
Mount Sinai Hospital (Toronto) — Toronto, Ontario, Canada
Centro Internacional de Estudios Clinicos (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 University School of Medicine — Shanghai, China
The Eighth Affiliated Hospital, Sun Yat-sen University — Shenzhen, China
Sichuan Provincial People's Hospital — 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
The Affiliated Hospital of Xuzhou Medical College — Xuzhou, China
Zhuzhou Central Hospital — Zhuzhou, China
CIREEM SAS (Centro de Investigacion en Reumatologia y Especialidades Medicas) — Bogotá, Colombia
Hospital Universitario San Ignacio de Bogota — Bogotá, Colombia
Corporacion Hospitalaria Juan Ciudad, Sede denominada Mederi — Bogotá, Colombia
Fundacion Clinica Universitaria Bolivariana — Medellín, Colombia
Klinicki Bolnicki Centar Osijek — Osijek, Croatia
Specijalna Bolnica 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
HOP Nord — Marseille, France
Centre Hospitalier Universitaire De Nantes — Nantes, France
Hôpital Cochin — Paris, France
HOP Sud — Rennes, France
HOP Civil — Strasbourg, France
Hôpital Rangueil - CHU de Toulouse — Toulouse, France
HOP Bretonneau — Tours, France
HOP Brabois — Vandœuvre-lès-Nancy, 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
Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany
Medizinische Hochschule Hannover — Hanover, Germany
Universitätsklinikum Heidelberg — Heidelberg, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck — Lübeck, 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 Debrecen — Debrecen, Hungary
University of Pecs — Pécs, Hungary
St John's Medical College — Bangalore, India
AIIMS Bhubaneshwar — Bhubaneswar, India
Medanta- The Medicity — Gurugram, India
Nizam's Institute of Medical Sciences — Hyderabad, India
Care hospital — Kochi, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute — Maharashtra, India
AIIMS, New Delhi — New Delhi, India
Bnai Zion Medical Center, Haifa — Haifa, Israel
Rambam Health Care Campus — Haifa, Israel
Meir Medical Center — Kfar Saba, Israel
Sheba MC — Ramat Gan, 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
Japan Community Healthcare Organization Chukyo Hospital — Aichi, Nagoya, Japan
Fujita Health University Hospital — Aichi, Toyoake, Japan
Hospital of the University of Occupational and Environmental Health — Fukuoka, Kitakyushu, Japan
Gifu Prefectural General Medical Center — Gifu, Gifu, Japan
Hiroshima University Hospital — Hiroshima, Hiroshima, Japan
Sapporo Medical University Hospital — Hokkaido, Sapporo, Japan
Hokkaido University Hospital — Hokkaido, Sapporo, Japan
Kanazawa University Hospital — Ishikawa, Kanazawa, Japan
Kagawa University Hospital — Kagawa, Kita-gun, Japan
St. Marianna University Hospital — Kanagawa, Kawasaki, Japan
Kitasato University Hospital — Kanagawa, Sagamihara, 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
Osaka Medical and Pharmaceutical University Hospital — Osaka, Takatsuki, Japan
Saitama Medical University Hospital — Saitama, Iruma-gun, 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
Centro Integral en Reumatologia, SA. de CV. — Guadalajara, Mexico
Hosptial General de Occidente — Jalisco, Mexico
Centro de Investigacion Farmacologica del Bajío, S.C. — León, 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
Clinical Research Institute S.C. — Tlalnepantla, Mexico
Universitair Medisch Centrum Groningen — Groningen, Netherlands
Radboud Universitair Medisch Centrum — Nijmegen, Netherlands
Erasmus Medisch Centrum — Rotterdam, Netherlands
Aotearoa Clinical Trials — Auckland, New Zealand
Waikato Hospital — Hamilton, New Zealand
Sørlandet sykehus HF Kristiansand — Kristiansand, Norway
Levanger sykehus — Levanger, Norway
Revmatismesykehuset 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 Universitario 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
Clinical Trials Network Helderberg — Somerset West, South Africa
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
Southmead Hospital — Bristol, United Kingdom
Chapel Allerton Hospital — Leeds, United Kingdom
Royal Free Hospital — London, United Kingdom
Salford Royal Hospital — Salford, United Kingdom
Bach Mai hospital — Hanoi, Vietnam
University Medical Center HCMC — Ho Chi Minh City, Vietnam

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