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NCT07497087PHASE3Recruiting

A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis

Boehringer Ingelheim

Start Date

7/27/2026

Completion Date

3/17/2030

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Placebo matching nerandomilast formulation 1

DRUG

Placebo matching nerandomilast formulation 2

DRUG

Nerandomilast formulation 1

DRUG

Nerandomilast formulation 2

Interested in This Trial?

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Conditions

Systemic Sclerosis

Locations

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 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

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

UMHAT Pulmed OOD

Plovdiv, 4002

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

Fundación Clínica 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

Centre Hospitalier Universitaire De Nantes

Nantes, 44093

France

Hôpital Cochin

Paris, 75014

France

HOP Sud

Rennes, 35000

France

HOP Civil

Strasbourg, 67091

France

Hôpital Rangueil - CHU de Toulouse

Toulouse, 31000

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

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

St John's Medical College

Bangalore, 560034

India

AIIMS Bhubaneshwar

Bhubaneswar, 751019

India

Medanta- The Medicity

Gurugram, 122001

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

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 Universitario 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

Southmead Hospital

Bristol, BS10 5NB

United Kingdom

Chapel Allerton Hospital

Leeds, LS7 4SA

United Kingdom

Royal Free Hospital

London, NW3 2QG

United Kingdom

Salford Royal

Salford, M6 8HD

United Kingdom

Bach Mai hospital

Hanoi, 100000

Vietnam

University Medical Center HCMC

Ho Chi Minh City, 70000

Vietnam