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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
2026-07-27
Completion Date
2030-03-17
Last Updated
2026-10-14
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 (248)
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