Systemic SclerosisPhase 3VERANDA™-SScNCT07497087
A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
A Phase 3 study testing Nerandomilast formulation 1 and Nerandomilast formulation 2 in people with Systemic Sclerosis, run by Boehringer Ingelheim at 248 sites in 45 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Nerandomilast formulation 1 and Nerandomilast formulation 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 448 participants
- Where
- 248 sitesin 45 countries
- Study dates
- 27 Jul 2026to 17 Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
- Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months. Further exclusion criteria apply.
Trial locations and contacts
248 sites in 45 countries. Contact the study team or a site near you to ask about taking part.
248 sites in 45 countries
United States30 sites, 30 recruiting
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
University of Colorado Denver
Aurora, Colorado, 80045
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Tekton Research, Inc - West Gate Boulevard
Austin, Texas, 78745
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21224
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Northwestern University
Chicago, Illinois, 60611
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
The University of Chicago Medical Center
Chicago, Illinois, 60637
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Arthritis & Rheumatology Institute - Frisco
Frisco, Texas, 75035
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
West Tennessee Research Institute
Jackson, Tennessee, 38305
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
University of California Los Angeles
Los Angeles, California, 90095
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
DelRicht Research-New Orleans-64100
New Orleans, Louisiana, 70115
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Hospital for Special Surgery
New York, New York, 10021
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Millennium Research - Ormond Beach
Ormond Beach, Florida, 32174
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Banner - University Medicine Rheumatology Clinic
Phoenix, Arizona, 85006
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Integral Rheumatology and Immunology Specialist
Plantation, Florida, 33324
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Clinical Research Institute of Michigan, LLC - St. Clair Shores
Saint Clair Shores, Michigan, 48081
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Paradigm Clinical Research - San Diego
San Diego, California, 92108
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Arizona Arthritis and Rheumatology Associates - Paradise Valley
Scottsdale, Arizona, 85032
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
BioResearch Partner - South Miami
South Miami, Florida, 33143
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Stanford University School of Medicine
Stanford, California, 94305
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Georgetown University
Washington D.C., District of Columbia, 20007
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Medvin Clinical Research-Whittier-69033
Whittier, California, 90602
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
China25 sites, 25 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Peking University First Hospital
Beijing, 100034
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
The First Hospital of Jilin University
Changchun, 130021
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Xiangya Hospital, Central South University
Changsha, 410008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The Second Xiangya Hospital Of Central South University
Changsha, 410011
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, 510080
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
The third affiliated hospital of Sun Yat-Sen University
Guangzhou, 510630
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Anhui Provincial Hospital
Hefei, 230001
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471003
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, 210008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, 315010
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Huashan Hospital, Fudan University
Shanghai, 200040
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 201112
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
The Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, 518033
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Sichuan Provincial People's Hospital
Sichuan, 610031
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, 30052
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, 430030
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
First Affiliated Hospital of Xiamen University
Xiamen, 361003
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, 221006
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Zhuzhou Central Hospital
Zhuzhou, 412007
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Japan20 sites, 20 recruiting
- Recruiting
Japan Community Healthcare Organization Chukyo Hospital
Aichi, Nagoya, 457-8510
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Fujita Health University Hospital
Aichi, Toyoake, 470-1192
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Gifu Prefectural General Medical Center
Gifu, Gifu, 500-8717
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Sapporo Medical University Hospital
Hokkaido, Sapporo, 060-8543
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Kanazawa University Hospital
Ishikawa, Kanazawa, 920-8641
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Kagawa University Hospital
Kagawa, Kita-gun, 761-0793
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
St. Marianna University Hospital
Kanagawa, Kawasaki, 216-8511
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Kitasato University Hospital
Kanagawa, Sagamihara, 252-0375
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Yokohama City University Hospital
Kanagawa, Yokohama, 236-0004
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Tohoku Medical and Pharmaceutical University Hospital
Miyagi, Sendai, 983-8512
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Osaka Medical and Pharmaceutical University Hospital
Osaka, Takatsuki, 569-8686
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Saitama Medical University Hospital
Saitama, Iruma-gun, 350-0495
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, 113-8603
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Toyama University Hospital
Toyama, Toyama, 930-0194
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
France12 sites, 12 recruiting
- Not yet recruiting
HOP Pellegrin
Bordeaux, 33076
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
HOP de la Cavale Blanche
Brest, 29609
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
HOP CHU Caen
Caen, 14000
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Annecy-Genevois
Epagny Metz-Tessy, 74370
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
HOP Nord
Marseille, 13015
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
Centre Hospitalier Universitaire De Nantes
Nantes, 44093
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
Hôpital Cochin
Paris, 75014
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Sud
Rennes, 35000
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
HOP Civil
Strasbourg, 67091
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
Hôpital Rangueil - CHU de Toulouse
Toulouse, 31000
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
HOP Bretonneau
Tours, 37044
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
HOP Brabois
Vandœuvre-lès-Nancy, 54511
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Germany11 sites, 11 recruiting
- Not yet recruiting
Auenlandklinik Bad Bramstedt GmbH
Bad Bramstedt, 24576
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Immanuel-Krankenhaus GmbH
Berlin, 13125
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Technische Universität Dresden
Dresden
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Medizinische Hochschule Hannover
Hanover, 30625
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Westfälische Wilhelms-Universität Münster
Münster
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Helios St. Elisabeth Klinik Oberhausen
Oberhausen, 46045
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Tübingen
Tübingen, 72076
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Helios Fachklinik Vogelsang-Gommern GmbH
Vogelsang, 39245
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Spain11 sites, 11 recruiting
- Recruiting
Hospital Germans Trias i Pujol
Badalona, 08916
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Universitario de Cruces
Barakaldo, 48903
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital del Mar
Barcelona, 08003
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Santa Creu i Sant Pau
Barcelona, 08041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Juan Ramón Jimenez
Huelva, 21005
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Universitari de Bellvitge
L'Hospitalet Del Llobregat, 08907
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
CS Parc Taulí
Sabadell, 08208
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Dr. Peset
Valencia, 46017
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Italy8 sites, 8 recruiting
- Recruiting
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60123
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Bari, 70124
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
A. O. Universitaria Careggi
Florence, 50134
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Istituto Ortopedico G.Pini
Milan, 20122
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Ospedale San Raffaele S.r.l.
Milan, 20132
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Azienda Ospedaliero-Universitaria di Modena
Modena, 41124
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
AOU Università degli Studi della Campania Luigi Vanvitelli
Naples, 80131
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Fondazione Policlinico Universitario Campus Bio-medico
Roma, 00128
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Mexico8 sites, 8 recruiting
- Not yet recruiting
Investigacion y Biomedicina de Chihuahua S.C.
Chihuahua City, 31020
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Mediadvance Clinical S.A.P.I de C.V.
Chihuahua City, 31203
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Centro Integral en Reumatologia, SA. de CV.
Guadalajara, 44160
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Hosptial General de Occidente
Jalisco, 45170
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Centro de Investigacion Farmacologica del Bajío, S.C.
León, 37160
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
Mexico City, 06700
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Clinical Research Institute S.C.
Tlalnepantla, 54055
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
India7 sites, 7 recruiting
- Not yet recruiting
St John's Medical College
Bangalore, 560034
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
AIIMS Bhubaneshwar
Bhubaneswar, 751019
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Medanta- The Medicity
Gurugram, 122001
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Nizam's Institute of Medical Sciences
Hyderabad, 500082
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Care hospital
Kochi, 682040
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Maharashtra, 400053
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
AIIMS, New Delhi
New Delhi, 110029
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
Argentina6 sites, 6 recruiting
- Recruiting
Centro Medico Reumatologico - OMI
CABA, 1015
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Mautalen- Salud e Investigacion
CABA, C1128AAF
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Instituto de Investigacion Clinica TyT
CABA, C1405BFN
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Sanatorio Maipu
Maipu, M5515DQA
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Instituto de Investigaciones Clinicas de Quilmes
Quilmes, B1878GEG
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Sanatorio de la Mujer
Rosario, S2000ORE
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Belgium6 sites, 6 recruiting
- Not yet recruiting
Hopital Erasme
Brussels, 1070
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Not yet recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Not yet recruiting
Universitair Ziekenhuis Brussel
Jette, 1090
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Not yet recruiting
UZ Leuven
Leuven, 3000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Not yet recruiting
Centre Hospitalier Universitaire de Liège
Liège, 4000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Not yet recruiting
CHU UCL Namur
Yvoir, 5530
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Brazil6 sites, 6 recruiting
- Recruiting
SAPIENS - Instituto de Estudos e Pesquisa Clinica
Curitiba, 80810-000
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90035-074
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Not yet recruiting
Hospital das Clinicas da Universidade Federal de Pernambuco
Recife, 50740900
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Hospital Mater Dei BA
Salvador, 40221-500
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Fundacao Oswaldo Ramos (Hospital do Rim)
São Paulo, 04038-002
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
A2Z Clinical Centro Avançado de Pesquisa Clinica
Valinhos, 13271-130
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Portugal6 sites, 6 recruiting
- Not yet recruiting
ULS de Almada -Seixal, E. P. E. - Hospital Garcia de Orta
Almada, 2801-951
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Not yet recruiting
CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, 3004-561
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Not yet recruiting
ULS de Santa Maria, E.P.E
Lisbon, 1649-035
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Not yet recruiting
ULSAM, EPE - Hospital Conde de Bertiandos
Ponte de Lima, 4990-041
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Not yet recruiting
Centro Hospitalar Universitário São João,EPE
Porto, 4200-319
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Not yet recruiting
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Porto, 4434-502
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
Norway5 sites, 5 recruiting
- Not yet recruiting
Sørlandet sykehus HF Kristiansand
Kristiansand, 4615
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
- Not yet recruiting
Levanger sykehus
Levanger, 7600
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
- Not yet recruiting
Revmatismesykehuset Lillehammer
Lillehammer, 2609
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
- Not yet recruiting
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, 0372
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
- Not yet recruiting
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, 4011
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
Poland5 sites, 5 recruiting
- Not yet recruiting
University Clinical Hospital in Bialystok I
Bialystok, 15-276
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Not yet recruiting
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Bydgoszcz, 85-168
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Not yet recruiting
Malopolskie Badania Kliniczne
Krakow, 30-002
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Not yet recruiting
Medical Center Hetmanska
Poznan, 60-218
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Not yet recruiting
Medicover Integrated Clinical Services Sp. z o.o.
Warsaw, 00874
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Canada4 sites, 4 recruiting
- Recruiting
CaRe Clinic (Calgary)
Calgary, Alberta, T2N 4L7
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Not yet recruiting
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, T6G 1Z1
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Not yet recruiting
St. Joseph's Health Care (London, Ontario)
London, Ontario, N6A 4V2
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Not yet recruiting
Mount Sinai Hospital (Toronto)
Toronto, Ontario, M5T 3L9
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Colombia4 sites, 4 recruiting
- Not yet recruiting
CIREEM SAS (Centro de Investigacion en Reumatologia y Especialidades Medicas)
Bogotá, 110231
Boehringer Ingelheim, 18005190813, colombia@bitrialsupport.com
- Not yet recruiting
Hospital Universitario San Ignacio de Bogota
Bogotá, 110231
Boehringer Ingelheim, 18005190813, colombia@bitrialsupport.com
- Not yet recruiting
Corporacion Hospitalaria Juan Ciudad, Sede denominada Mederi
Bogotá, 111411
Boehringer Ingelheim, 18005190813, colombia@bitrialsupport.com
- Recruiting
Fundacion Clinica Universitaria Bolivariana
Medellín, 50034
Boehringer Ingelheim, 18005190813, colombia@bitrialsupport.com
Georgia4 sites, 4 recruiting
- Not yet recruiting
Emergency Cardiology Center by Academician G. Chapidze
Tbilisi, 0159
Boehringer Ingelheim, 800008086, sakartvelo@bitrialsupport.com
- Not yet recruiting
LTD Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, 112
Boehringer Ingelheim, 800008086, sakartvelo@bitrialsupport.com
- Not yet recruiting
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 141
Boehringer Ingelheim, 800008086, sakartvelo@bitrialsupport.com
- Not yet recruiting
LLC Mtskheta street Clinic
Tbilisi, 179
Boehringer Ingelheim, 800008086, sakartvelo@bitrialsupport.com
Israel4 sites, 4 recruiting
- Not yet recruiting
Bnai Zion Medical Center, Haifa
Haifa, 31048
Boehringer Ingelheim, 1809388162, israel@bitrialsupport.com
- Not yet recruiting
Rambam Health Care Campus
Haifa, 3109601
Boehringer Ingelheim, 1809388162, israel@bitrialsupport.com
- Not yet recruiting
Meir Medical Center
Kfar Saba, 44281
Boehringer Ingelheim, 1809388162, israel@bitrialsupport.com
- Not yet recruiting
Sheba MC
Ramat Gan, 52621
Boehringer Ingelheim, 1809388162, israel@bitrialsupport.com
Romania4 sites, 4 recruiting
- Not yet recruiting
Delta Health Care
Bucharest, 014142
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
- Not yet recruiting
S.C. Policlinica CCBR S.R.L.
Bucharest, 030463
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
- Not yet recruiting
Spitalul Clinic Judetean de urgenta Cluj
Cluj-Napoca, 400006
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
- Not yet recruiting
Aqua Clinic (AquaMed Consulting SRL- juridic)
Constanța, 900622
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
South Korea4 sites, 4 recruiting
- Recruiting
Kyung Hee University Hospital
Seoul, 02447
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Seoul National University Hospital
Seoul, 03080
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Soonchunhyang University Hospital Seoul
Seoul, 04401
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Ajou University Hospital
Suwon, 16499
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Thailand4 sites, 4 recruiting
- Not yet recruiting
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
- Not yet recruiting
Ramathibodi Hospital
Bangkok, 10400
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
- Not yet recruiting
Siriraj Hospital
Bangkoknoi, 10700
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
- Recruiting
Srinagarind Hospital
Khon Kaen, 40002
Boehringer Ingelheim, 1800019059, thai@bitrialsupport.com
United Kingdom4 sites, 4 recruiting
- Recruiting
Southmead Hospital
Bristol, BS10 5NB
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Not yet recruiting
Chapel Allerton Hospital
Leeds, LS7 4SA
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Not yet recruiting
Royal Free Hospital
London, NW3 2QG
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Not yet recruiting
Salford Royal Hospital
Salford, M6 8HD
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Australia3 sites, 3 recruiting
- Not yet recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Not yet recruiting
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Not yet recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Croatia3 sites, 3 recruiting
- Not yet recruiting
Klinicki Bolnicki Centar Osijek
Osijek, 31000
Boehringer Ingelheim, 08007744, hrvatska@bitrialsupport.com
- Not yet recruiting
Specijalna Bolnica Medico
Rijeka, 51000
Boehringer Ingelheim, 08007744, hrvatska@bitrialsupport.com
- Not yet recruiting
Solmed Polyclinic
Zagreb, 10000
Boehringer Ingelheim, 08007744, hrvatska@bitrialsupport.com
Estonia3 sites, 3 recruiting
- Not yet recruiting
East Tallinn Central Hospital
Tallinn, 11312
Boehringer Ingelheim, 8000044842, eesti@bitrialsupport.com
- Not yet recruiting
North Estonia Medical Centre Foundation, Tallinn
Tallinn, 13419
Boehringer Ingelheim, 8000044842, eesti@bitrialsupport.com
- Not yet recruiting
Tartu University Hospital
Tartu, 50406
Boehringer Ingelheim, 8000044842, eesti@bitrialsupport.com
Finland3 sites, 3 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, 00290
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
- Not yet recruiting
Northern Clinical Trial Coordinators
Oulu, 90150
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
- Not yet recruiting
Turku University Hospital / TYKS
Turku, 20520
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
Greece3 sites, 3 recruiting
- Not yet recruiting
IASO General
Athens, 151 23
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Not yet recruiting
Univ. Gen. Hosp. of Ioannina
Ioannina, 45 500
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Not yet recruiting
General Hospital of Thessaloniki "Ippokrateio"
Thessaloniki, 546 42
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
Hungary3 sites, 3 recruiting
- Not yet recruiting
Semmelweis University
Budapest, 1023
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
University of Debrecen
Debrecen, 4032
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
University of Pecs
Pécs, 7634
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
Malaysia3 sites, 3 recruiting
- Recruiting
Hospital Selayang
Batu Caves, 68100
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Not yet recruiting
University Malaya Medical Centre
Kuala Lumpur, 59100
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Recruiting
Sarawak General Hospital
Kuching, 93586
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
Netherlands3 sites, 3 recruiting
- Not yet recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
- Not yet recruiting
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
- Not yet recruiting
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
Philippines3 sites, 3 recruiting
- Recruiting
Manila Doctors Hospital
Manila, 1000
Boehringer Ingelheim, 180084748502, pilipinas@bitrialsupport.com
- Not yet recruiting
Ospital ng Makati
Metro Manil, 1218
Boehringer Ingelheim, 180084748502, pilipinas@bitrialsupport.com
- Not yet recruiting
Philippine General Hospital
Taft, Manila, 1000
Boehringer Ingelheim, 180084748502, pilipinas@bitrialsupport.com
Austria2 sites, 2 recruiting
- Not yet recruiting
Medizinische Universitaet Innsbruck
Innsbruck, 6020
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
- Not yet recruiting
Ordensklinikum Linz GmbH
Linz, 4020
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
Bulgaria2 sites, 2 recruiting
- Not yet recruiting
UMHAT Pulmed OOD
Plovdiv, 4002
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
- Not yet recruiting
Diagnostic Consultative Center Alexandrovska
Sofia, 1431
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
Chile2 sites, 2 recruiting
- Recruiting
Centro Internacional de Estudios Clinicos (CIEC)
Comuna de Recoleta, 8420383
Boehringer Ingelheim, 800392345, chile@bitrialsupport.com
- Recruiting
Ctr Estudios
Providencia, 7500571
Boehringer Ingelheim, 800392345, chile@bitrialsupport.com
Czechia2 sites, 2 recruiting
- Not yet recruiting
University Hospital Brno
Brno, 625 00
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Not yet recruiting
Revmatologicky Ustav
Prague, 12800
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
Denmark2 sites, 2 recruiting
- Not yet recruiting
Rigshospitalet Copenhagen
Copenhagen, 2100
Boehringer Ingelheim, 80711822, danmark@bitrialsupport.com
- Not yet recruiting
Odense University Hospital
Odense C, 5000
Boehringer Ingelheim, 80711822, danmark@bitrialsupport.com
Lithuania2 sites, 2 recruiting
- Not yet recruiting
Kaunas City Policlinic
Kaunas, 51270
Boehringer Ingelheim, 080080099, lithuania@bitrialsupport.com
- Not yet recruiting
Vilnius University Hospital, Santariskiu
Vilnius, 08406
Boehringer Ingelheim, 080080099, lithuania@bitrialsupport.com
New Zealand2 sites, 2 recruiting
- Recruiting
Aotearoa Clinical Trials
Auckland, 2025
Boehringer Ingelheim, 0800440725, newzealand@bitrialsupport.com
- Not yet recruiting
Waikato Hospital
Hamilton, 3240
Boehringer Ingelheim, 0800440725, newzealand@bitrialsupport.com
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Boehringer Ingelheim, 8001207344, singapore@bitrialsupport.com
- Not yet recruiting
Singapore General Hospital
Singapore, 169608
Boehringer Ingelheim, 8001207344, singapore@bitrialsupport.com
Taiwan2 sites, 2 recruiting
- Not yet recruiting
China Medical University Hospital
Taichung, 404
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Not yet recruiting
Taichung Veterans General Hospital
Taichung, 40705
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Vietnam2 sites, 2 recruiting
- Not yet recruiting
Bach Mai hospital
Hanoi, 100000
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Not yet recruiting
University Medical Center HCMC
Ho Chi Minh City, 70000
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
South Africa1 site, 1 recruiting
- Not yet recruiting
Clinical Trials Network Helderberg
Somerset West, 7130
Boehringer Ingelheim, 0800988886, southafrica@bitrialsupport.com
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Universitetssjukhuset
Stockholm, 171 76
Boehringer Ingelheim, 0200880001, sverige@bitrialsupport.com
Switzerland1 site, 1 recruiting
- Not yet recruiting
HOCH Health Ostschweiz
Sankt Gallen, 9007
Boehringer Ingelheim, 0800005900, suisse@bitrialsupport.com
About this study
Official title: 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.
- Conditions
- Systemic Sclerosis
- Being tested
- Placebo matching nerandomilast formulation 1, Placebo matching nerandomilast formulation 2, Nerandomilast formulation 1, Nerandomilast formulation 2
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo matching nerandomilast formulation 1Drug
Film-coated tablets
Placebo matching nerandomilast formulation 2Drug
Film-coated tablets
Nerandomilast formulation 1Drug
Film-coated tablets
Nerandomilast formulation 2Drug
Film-coated tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo matching nerandomilast formulation 1; Drug: Placebo matching nerandomilast formulation 2 |
| Nerandomilast | Experimental | Not described Receives: Drug: Nerandomilast formulation 1; Drug: Nerandomilast formulation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first occurrence of disease progression or all-cause death
Measured: up to 4 years
Secondary outcomes (10)
Change from baseline in mRSS 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).
Measured: At baseline and at Week 52.
Change from baseline in HAQ-DI score 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.
Measured: At baseline and at Week 52.
Change from baseline in FVC [mL] at Week 52
Forced vital capacity (FVC)
Measured: At baseline and at Week 52.
Disease improvement as defined by rCRISS-25 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).
Measured: 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
Measured: 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
Measured: up to 4 years
Time to first occurrence of adjudicated SSc-related related clinically meaningful disease progression or complication or death
Measured: up to 4 years
Time to all-cause death
Measured: up to 4 years
Change from baseline in Systemic Sclerosis Impact of Disease (ScleroID) score 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.
Measured: At baseline and at Week 52.
Change from baseline in digital ulcer total burden at Week 52
Measured: At baseline and at Week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start27 Jul 2026
- Primary completion26 Feb 2030 (estimated)
- Study completion17 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497087
- Sponsor's protocol ID
- 1305-0052
- Other IDs
- 2025-523884-39-00, U1111-1329-6365, 2025
- Acronym
- VERANDA™-SSc
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)
- ClinicalTrials.gov ID
- NCT07497087
- Acronym / sponsor ID
- VERANDA™-SSc / 1305-0052
- Conditions
- Systemic Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 26 Feb 2030 (estimated)
- Study completion
- 17 Mar 2030 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo matching nerandomilast formulation 1, Drug: Placebo matching nerandomilast formulation 2 |
| Nerandomilast | Experimental | Drug: Nerandomilast formulation 1, Drug: Nerandomilast formulation 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
- Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months. Further exclusion criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo matching nerandomilast formulation 1Film-coated tablets | Drug | Placebo |
| Placebo matching nerandomilast formulation 2Film-coated tablets | Drug | Placebo |
| Nerandomilast formulation 1Film-coated tablets | Drug | Nerandomilast |
| Nerandomilast formulation 2Film-coated tablets | Drug | Nerandomilast |
Primary outcome
Time to the first occurrence of disease progression or all-cause death
Time frame: up to 4 years
10 secondary outcomes
Change from baseline in mRSS at Week 52
Time frame: At baseline and at Week 52.
Change from baseline in HAQ-DI score at Week 52
Time frame: At baseline and at Week 52.
Change from baseline in FVC [mL] at Week 52
Time frame: At baseline and at Week 52.
Disease improvement as defined by rCRISS-25 at Week 52
Time frame: 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
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
Time to first occurrence of adjudicated SSc-related related clinically meaningful disease progression or complication or death
Time frame: up to 4 years
Time to all-cause death
Time frame: 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.
Change from baseline in digital ulcer total burden at Week 52
Time frame: At baseline and at Week 52.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
248 sites in 45 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nerandomilast formulation 1 and Nerandomilast formulation 2 in people with Systemic Sclerosis, run by Boehringer Ingelheim at 248 sites in 45 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 248 sites in United States, China, Japan, France, Germany and 40 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the first occurrence of disease progression or all-cause death (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.