A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
VERANDA™-SSc
A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)
3 other identifiers
interventional
448
42 countries
222
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2026
Typical duration for phase_3
222 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2026
CompletedFirst Posted
Study publicly available on registry
March 27, 2026
CompletedStudy Start
First participant enrolled
June 22, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2030
Study Completion
Last participant's last visit for all outcomes
March 17, 2030
June 10, 2026
June 1, 2026
3.7 years
March 23, 2026
June 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to the first occurrence of disease progression or all-cause death
up to 4 years
Secondary Outcomes (10)
Change from baseline in mRSS at Week 52
At baseline and at Week 52.
Change from baseline in HAQ-DI score at Week 52
At baseline and at Week 52.
Change from baseline in FVC [mL] at Week 52
At baseline and at Week 52.
Disease improvement as defined by rCRISS-25 at Week 52
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
up to 4 years
- +5 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORNerandomilast
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- 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.
- Patients must be diagnosed with limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc), as defined by LeRoy et al. (1988).
- Disease onset (defined by first non-RP \[Raynaud's phenomenon\] symptom) must be within 7 years of Visit 1.
- Trial participants with dcSSc must have evidence of active disease during screening.
- Trial participants with lcSSc must have evidence of active disease during screening. LcSSc patients must be anti-centromere antibody (ACA) negative.
- FVC % predicted ≥45% at Visit 1.
- Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted ≥25% corrected for haemoglobin (Hb) at Visit 1.
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control.
- 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
You may not qualify if:
- Active, unstable, or uncontrolled vasculitis within 8 weeks prior to Visit 1 or during the screening period.
- Any suicidal behaviour in the past 2 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (235)
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 Prince Alfred Hospital
Camperdown, Sydney, New South Wales, 2050, Australia
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
ULB 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
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
Universidad Pontificia Bolivariana - Clinica 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
Hôpital Cochin
Paris, 75014, France
HOP Sud
Rennes, 35000, France
HOP Civil
Strasbourg, 67091, France
Hôpital Rangueil - CHU de Toulouse
Toulouse, 31059, 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
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, 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
AIIMS Bhubaneshwar
Bhubaneswar, 751019, 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
Papatoetoe, 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 Universitário 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
108 Military Central Hospital
Hà Nội, Vietnam
University Medical Center HCMC
Ho Chi Minh City, 70000, Vietnam
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2026
First Posted
March 27, 2026
Study Start (Estimated)
June 22, 2026
Primary Completion (Estimated)
February 26, 2030
Study Completion (Estimated)
March 17, 2030
Last Updated
June 10, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.