A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

214

Participants

Timeline

Start Date

December 13, 2022

Primary Completion Date

October 22, 2025

Study Completion Date

February 27, 2026

Conditions
Scleroderma, Systemic
Interventions
DRUG

Avenciguat (BI 685509)

Avenciguat (BI 685509)

DRUG

Placebo

Placebo

Trial Locations (167)

100

National Taiwan University Hospital, Taipei

1000

Manila Doctors Hospital, Manila

1056

Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553, C.a.b.a

1070

ULB Hopital Erasme, Brussels

1112

St. Luke's Medical Center-Quezon-59457, Quezon City

2050

Royal Prince Alfred Hospital, Camperdown

2145

Westmead Hospital, Westmead

2170

Liverpool Hospital, Liverpool

3000

UZ Leuven, Leuven

3065

St Vincent's Hospital Melbourne, Fitzroy

3204

Waikato Hospital, Hamilton

4000

Centre Hospitalier Universitaire de Liège, Liège

4020

Ordensklinikum Linz GmbH, Linz

5000

Royal Adelaide Hospital, Adelaide

7600

Centro de Investigaciones Medicas Mar del Plata, Mar del Plata

8036

Medical University of Graz State Hospital - University Hospital Graz, Graz

8091

University Hospital Zurich, Zurich

8200

Aarhus University Hospital, Aarhus N

9000

UNIV UZ Gent, Ghent

9007

Kantonsspital St.Gallen, Sankt Gallen

10117

Charite Universitätsmedizin Berlin KöR, Berlin

10400

Ramathibodi Hospital, Ratchathewi

11172

St. Mary's Clinical Hospital, Bucharest

11527

"General Hospital of Athens Laiko", Athens

12800

Institute of Rheumathology Prague, Prague

15706

Hospital Clínico de Santiago, Santiago de Compostela

16132

Azienda Ospedaliera San Martino, Genova

19107

Thomas Jefferson University, Philadelphia

20122

Istituto Ortopedico G.Pini, Milan

20132

IRCCS San Raffaele, Milan

20521

TYKS, Turku

23200

Firat University Hospital, Elâzığ

25123

A.O. Spedali Civili di Brescia, Brescia

28034

Hospital Universitario Ramon Y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

30052

Tianjin Medical University General Hospital, Tianjin

30322

The Emory Clinic, Atlanta

30912

Augusta University, Augusta

31020

Investigacion y Biomedicina de Chihuahua S.C., Chihuahua City

31059

HOP Rangueil, Toulouse

32224

Mayo Clinic - Florida, Jacksonville

32610

University of Florida, Gainesville

33324

Iris Research and Development, Plantation

35003

HOP Pontchaillou, Rennes

35233

University of Alabama at Birmingham, Birmingham

40002

Srinagarind Hospital, Muang

41100

Azienda Ospedaliera Policlinico di Modena, Modena

44093

HOP Hôtel-Dieu, Nantes

44160

Centro Integral en Reumatologia, SA. de CV., Guadalajara

45219

University of Cincinnati Medical Center, Cincinnati

46017

Hospital Dr. Peset, Valencia

48109

University of Michigan Health System, Ann Arbor

48149

Westfälische Wilhelms-Universität Münster, Münster

50139

Azienda Ospedaliera Careggi, Florence

50200

Maharaj Nakom Chiangmai Hospital, Chiang Mai

50937

Universitätsklinikum Köln (AöR), Cologne

52242

University of Iowa Hospitals and Clinics, Iowa City

54500

HOP Brabois, Vandœuvre-lès-Nancy

55905

Mayo Clinic, Rochester, Rochester

59100

University of Malaya Medical Centre, Kuala Lumpur

60126

Ospedali Riuniti di Ancona, Ancona

67091

HOP Civil, Strasbourg

68000

Oaxaca Site Management Organization, S.C., Oaxaca City

68100

Hospital Selayang, Kuala Selangor

69120

Universitätsklinikum Heidelberg, Heidelberg

70210

Kuopio University Hospital, Kuopio

74370

HOP Annecy-Genevois, Epagny Metz-Tessy

75014

HOP Cochin, Paris

77030

The University of Texas Health Science Center at Houston, Houston

80337

Klinikum der Universität München AÖR, München

85259

Mayo Clinic, Scottsdale

90095

University of California Los Angeles, Los Angeles

90110

Songklanagarind Hospital, Hat Yai

90301

Southern California Scleroderma and Rheumatology Center, Inglewood

90602

Medvin Clinical Research-Whittier-69033, Whittier

91054

Universitätsklinikum Erlangen, Erlangen

91722

Medvin Clinical Research-Covina-67001, Covina

97070

Medical Care & Research SA de CV, Mérida

100032

Peking Union Medical College Hospital, Beijing

100191

Peking University Third Hospital, Beijing

110029

All India Institute of Medical Sciences, New Delhi

130021

The First Hospital of Jilin University, Changchun

160012

Post Graduate Institute of Medical Education and Research, Chandigarh

169608

Singapore General Hospital, Singapore

200040

Huashan Hospital, Fudan University, Shanghai

210008

Nanjing Drum Tower Hospital, Nanjing

215006

The First Affiliated Hospital of Soochow University, Suzhou

233004

The First Affiliated Hospital Of Bengbu Medical College, Bengbu

240762

SC Medaudio Optica SRL, Râmnicu Vâlcea

308433

Tan Tock Seng Hospital, Singapore

310009

The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

315010

The First Affiliated Hospital of Ningbo University, Ningbo

325000

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

400006

Cluj Napoca Clinical County Hospital, Cluj-Napoca

400053

Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute, Maharashtra

411001

Grant Medical Foundation, Ruby Hall Clinic, Pune

422005

Chopda Medicare and Research Centre Pvt Ltd, Maharashtra

430022

Wuhan Union Hospital, Wuhan

430030

Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T, Wuhan

500003

Krishna Institute of Medical Sciences, Secunderabad

500283

C.M.D.T.A. NEOMED, Brasov, Brasov

510080

Guangdong Provincial People's Hospital, Guangzhou

510630

The third affiliated hospital of Sun Yat-Sen University, Guangzhou

600114

Bacau County Hospital, Bacau

610041

West China Hospital of Sichuan University, Chengdu

700020

Institute of Post Graduate Medical Education and Research, Kolkata

900622

Aqua Clinic (AquaMed Consulting SRL- juridic), Constanța

2210001

Western Galilee Hospital, Nahariya

3109601

Rambam Medical Center, Haifa

3339419

Bnai Zion Medical Center, Haifa, Haifa

4428164

Meir Medical Center, Kfar Saba

5262000

The Chaim Sheba Medical Center Tel HaShomer, Ramat Gan

7640881

Clínica Dermacross S.A., Vitacura

8420383

Centro Internacional de Estudios Clínicos (CIEC), Comuna de Recoleta

06519

Yale University School of Medicine, New Haven

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

1280AEB

Hospital Britanico de Buenos Aires, CABA

C1023AAB

STAT Research, CABA

C1405BFN

Instituto de Investigación Clínica TyT, CABA

C1425DKG

Psoriahue Medicina Interdisciplinaria S.R.L, CABA

B1900AXI

Hospital Italiano de La Plata, La Plata

80440-210

Edumed - Educacao e Saude SA, Curitiba

90035-903

Hospital de Clínicas de Porto Alegre, Porto Alegre

09780-000

CEMEC - Centro Multidisciplinar de Estudos Clínicos, São Bernardo do Campo

04023-062

Hospital do RIM - UNIFESP, São Paulo

V1Y 1S1

St. Paul's Hospital (Vancouver), Vancouver

L8N 4A6

St. Joseph's Healthcare Hamilton, Hamilton

M5T 3L9

Mount Sinai Hospital-Toronto-18157, Toronto

H2X 0A9

Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal

686 01

Medical Plus s.r.o., Rheumatology Outpatient Clinic, Uherské Hradiště

115 27

"General Hospital of Athens Laiko", Athens

560 034

St John's Medical College, Bangalore

682018,

Sree Sudheendra Medical Mission, Kochi

00128

Fondazione Policlinico Universitario Campus Bio-medico, Roma

00161

AOU Policlinico Umberto I, Roma

00195

Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma

457-8510

Japan Community Healthcare Organization Chukyo Hospital, Aichi, Nagoya

807-8555

Hospital of the University of Occupational and Environmental Health, Fukuoka, Kitakyushu

060-8648

Hokkaido University Hospital, Hokkaido, Sapporo

920-8641

Kanazawa University Hospital, Ishikawa, Kanazawa

606-8507

Kyoto University Hospital, Kyoto, Kyoto

565-0871

The University of Osaka Hospital, Osaka, Suita

113-8603

Nippon Medical School Hospital, Tokyo, Bunkyo-ku

641-8509

Wakayama Medical University Hospital, Wakayama, Wakayama

2333 ZA

Leids Universitair Medisch Centrum (LUMC), Leiden

6525 GA

Radboud Universitair Medisch Centrum, Nijmegen

N-0372

Oslo Universitetssykehus HF, Rikshospitalet, Oslo

30-002

Malopolska Clinical Research, Krakow

60-218

Medical Center Hetmanska, Poznan

02-507

National Medical Institute MSWiA, Warsaw

02-637

Prof Eleonora Reicher Memorial Institute of Rheumatology, Warsaw

04 141

Military Medical Institute- National Research Institute, Warsaw

2801-951

ULS de Almada -Seixal, E. P. E. - Hospital Garcia de Orta, Almada

020475

Dr. Ion Cantacuzino Clinical Hospital, Bucharest

030463

S.C. Policlinica CCBR S.R.L., Bucharest

03080

Seoul National University Hospital, Seoul

04401

Soonchunhyang University Hospital Seoul, Seoul

04763

Hanyang University Medical Center, Seoul

08026

Hospital Santa Creu i Sant Pau, Barcelona

08035

Hospital Universitari Vall D Hebron, Barcelona

413 45

Clinical Rheumatology Research Center Sahlgrenska, Gothenburg

07070

Akdeniz Universitesi Tip Fakultesi -ANTALYA-33606, Antalya

LS7 4SA

Chapel Allerton Hospital, Leeds

L9 7AL

Aintree University Hospital, Liverpool

NW3 2QG

Royal Free Hospital, London

M6 8HD

Salford Royal, Salford

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY