Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New scleroderma pill shows promise in slowing lung damage

NCT ID NCT05559580

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a medicine called Avenciguat (BI 685509) in 214 adults with scleroderma, a disease that can cause skin hardening and lung or blood vessel damage. Participants took either the study drug or a placebo three times daily for at least 11 months. Researchers measured lung function and skin changes to see if the drug could slow disease progression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

214 people

The number who actually took part.

Started

Dec 2022

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial. 2. Male or female patients aged ≥18 years at time of consent (or above legal age, e.g. United Kingdom (UK) ≥16 years). 3. Patients must fulfill the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for Systemic sclerosis (SSc). 4. Patients must be diagnosed with limited or with diffuse cutaneous SSc as defined by LeRoy et al. (R17 0149). Patients diagnosed with limited cutaneous SSc may be included if they are anti Scl-70 antibody positive. 5. Diffuse cutaneous SSc disease onset (defined by first non-RP symptom) in patients with diffuse cutaneous SSc must be within 7 years of Visit 1. Limited cutaneous SSc onset must be within 2 years of Visit 1. 6. Evidence of active disease, defined as having at least one of the following: * New onset of SSc within the last 2 years of Visit 1 OR * New skin involvement or worsening of two new body areas within 6 months of Visit 1 (out of the possible 17 body areas defined by Modified Rodnan Skin Score (mRSS) assessment, documented in clinical files) OR * New involvement or worsening of one new body area if either chest or abdomen within 6 months of Visit 1 OR * Worsening of skin thickening (e.g. ≥2 mRSS points) within 6 months of Visit 1 OR * ≥1 tendon friction rub 7. Elevated biomarkers on Visit 1 (screening) defined as at least one of the following: * C-reactive protein (CRP) ≥6 mg/L (≥0.6 mg/dL), OR * Erythrocyte sedimentation rate (ESR) ≥28 mm/h, OR * Krebs von den Lungen 6 (KL-6) ≥1000 U/mL If none of the three criteria are met or respective test results should not be available, the patient can be entered if the modified Disease Activity Index (mDAI) is ≥ 2.5. 8. Evidence of significant vasculopathy, defined as: * Active Digital ulcer (DU(s)) on Visit 1 OR * Documented history of DU(s), OR * Previous treatment of RP with prostacyclin analogues or ≥ 1 other medications, including calcium channel blockers, nitrates,, NO donors in any form, including topical; phosphodiesterase 5 (PDE5) inhibitors (e.g. sildenafil, tadalafil, vardenafil); nonspecific PDE5 inhibitors (theophylline, dipyridamole) OR * RP with elevated CRP ≥6 mg/L * If none of the four criteria above are met, the patient can be entered if the diagnosis of Interstitial lung disease (ILD) has been confirmed Further inclusion criteria apply. Exclusion Criteria: 1. Any known form of pulmonary hypertension. 2. Pulmonary disease with FVC \<50% of predicted. at screening. 3. Other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma-associated myopathy and secondary Sjogren syndrome. 4. Diffusing capacity for carbon monoxide (DLCO) (haemoglobin corrected) \<40% of predicted at screening. 5. Any history of scleroderma renal crisis within the last 6 months. 6. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology (CKD-EPI) formula) or on dialysis at screening. 7. Cirrhosis of any Child-Pugh class (A, B or C). 8. Cholestasis at present, or Alkaline phosphatase (ALP) \> 4 x Upper limit of normal (ULN), or ALP \> 2 x ULN and Gamma-glutamyl transferase (GGT) \> 3 x ULN at Screening. Further exclusion criteria apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Scleroderma, systemic are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Scleroderma, systemic

Contacts and locations

Locations

  • A.O. Spedali Civili di Brescia

    Brescia, 25123, Italy

  • AOU Policlinico Umberto I

    Roma, 00161, Italy

  • Aarhus University Hospital

    Aarhus N, 8200, Denmark

  • Aintree University Hospital

    Liverpool, L9 7AL, United Kingdom

  • Akdeniz Universitesi Tip Fakultesi -ANTALYA-33606

    Antalya, 07070, Turkey (Türkiye)

  • All India Institute of Medical Sciences

    New Delhi, 110029, India

  • Aqua Clinic (AquaMed Consulting SRL- juridic)

    Constanța, 900622, Romania

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Azienda Ospedaliera San Martino

    Genova, 16132, Italy

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50139, Italy

  • Azienda Ospedaliero-Universitaria di Modena

    Modena, 41124, Italy

  • Bacau County Hospital

    Bacau, 600114, Romania

  • Bnai Zion Medical Center, Haifa

    Haifa, 3339419, Israel

  • C.M.D.T.A. NEOMED, Brasov

    Brasov, 500283, Romania

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, 09780-000, Brazil

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000, Belgium

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

    Montreal, Quebec, H2X 0A9, Canada

  • Centro Integral en Reumatologia, SA. de CV.

    Guadalajara, 44160, Mexico

  • Centro Internacional de Estudios Clínicos (CIEC)

    Comuna de Recoleta, 8420383, Chile

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, 7600, Argentina

  • Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553

    C.a.b.a, 1056, Argentina

  • Chapel Allerton Hospital

    Leeds, LS7 4SA, United Kingdom

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chopda Medicare and Research Centre Pvt Ltd

    Maharashtra, 422005, India

  • Clinical Rheumatology Research Center Sahlgrenska

    Gothenburg, 413 45, Sweden

  • Cluj Napoca Clinical County Hospital

    Cluj-Napoca, 400006, Romania

  • Clínica Dermacross S.A.

    Vitacura, 7640881, Chile

  • Dr. Ion Cantacuzino Clinical Hospital

    Bucharest, 020475, Romania

  • Firat University Hospital

    Elâzığ, 23200, Turkey (Türkiye)

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00195, Italy

  • Fondazione Policlinico Universitario Campus Bio-medico

    Roma, 00128, Italy

  • General Hospital of Athens "Laiko"

    Athens, 115 27, Greece

  • General Hospital of Athens "Laiko"

    Athens, 11527, Greece

  • Grant Medical Foundation, Ruby Hall Clinic

    Pune, 411001, India

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080, China

  • HOP Annecy-Genevois

    Epagny Metz-Tessy, 74370, France

  • HOP Brabois

    Vandœuvre-lès-Nancy, 54500, France

  • HOP Civil

    Strasbourg, 67091, France

  • HOP Hôtel-Dieu

    Nantes, 44093, France

  • HOP Pontchaillou

    Rennes, 35003, France

  • Hanyang University Medical Center

    Seoul, 04763, South Korea

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648, Japan

  • Hospital Britanico de Buenos Aires

    CABA, 1280AEB, Argentina

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706, Spain

  • Hospital Dr. Peset

    Valencia, 46017, Spain

  • Hospital Italiano de La Plata

    La Plata, B1900AXI, Argentina

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08026, Spain

  • Hospital Selayang

    Kuala Selangor, 68100, Malaysia

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035-903, Brazil

  • Hospital do RIM - UNIFESP

    São Paulo, 04023-062, Brazil

  • Hospital of the University of Occupational and Environmental Health

    Fukuoka, Kitakyushu, 807-8555, Japan

  • Huashan Hospital, Fudan University

    Shanghai, 200040, China

  • Hôpital Cochin

    Paris, 75014, France

  • Hôpital Rangueil - CHU de Toulouse

    Toulouse, 31059, France

  • Institute of Rheumathology Prague

    Prague, 12800, Czechia

  • Instituto de Investigación Clínica TyT

    CABA, C1405BFN, Argentina

  • Investigacion y Biomedicina de Chihuahua S.C.

    Chihuahua City, 31020, Mexico

  • Iris Research and Development

    Plantation, Florida, 33324, United States

  • Istituto Ortopedico G.Pini

    Milan, 20122, Italy

  • Japan Community Healthcare Organization Chukyo Hospital

    Aichi, Nagoya, 457-8510, Japan

  • Kanazawa University Hospital

    Ishikawa, Kanazawa, 920-8641, Japan

  • Kantonsspital St.Gallen

    Sankt Gallen, 9007, Switzerland

  • Klinikum der Universität München AÖR

    München, 80337, Germany

  • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute

    Maharashtra, 400053, India

  • Krishna Institute of Medical Sciences

    Secunderabad, 500003, India

  • Kuopio University Hospital

    Kuopio, 70210, Finland

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507, Japan

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA, Netherlands

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Maharaj Nakom Chiangmai Hospital

    Chiang Mai, 50200, Thailand

  • Malopolska Clinical Research

    Krakow, 30-002, Poland

  • Manila Doctors Hospital

    Manila, 1000, Philippines

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic - Florida

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905, United States

  • Medical Care & Research SA de CV

    Mérida, 97070, Mexico

  • Medical Center Hetmanska

    Poznan, 60-218, Poland

  • Medical Plus s.r.o., Rheumatology Outpatient Clinic

    Uherské Hradiště, 686 01, Czechia

  • Medical University of Graz State Hospital - University Hospital Graz

    Graz, 8036, Austria

  • Medvin Clinical Research-Covina-67001

    Covina, California, 91722, United States

  • Medvin Clinical Research-Whittier-69033

    Whittier, California, 90602, United States

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • Military Medical Institute- National Research Institute

    Warsaw, 04 141, Poland

  • Mount Sinai Hospital (Toronto)

    Toronto, Ontario, M5T 3L9, Canada

  • Nanjing Drum Tower Hospital

    Nanjing, 210008, China

  • National Medical Institute MSWiA

    Warsaw, 02-507, Poland

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Nippon Medical School Hospital

    Tokyo, Bunkyo-ku, 113-8603, Japan

  • Oaxaca Site Management Organization, S.C.

    Oaxaca City, 68000, Mexico

  • Ordensklinikum Linz GmbH

    Linz, 4020, Austria

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, N-0372, Norway

  • Ospedale San Raffaele S.r.l.

    Milan, 20132, Italy

  • Ospedali Riuniti di Ancona

    Ancona, 60126, Italy

  • Peking Union Medical College Hospital

    Beijing, 100032, China

  • Peking University Third Hospital

    Beijing, 100191, China

  • Post Graduate Institute of Medical Education and Research

    Chandigarh, 160012, India

  • Post Graduate Institute of Medical Education and Research

    Kolkata, 700020, India

  • Prof Eleonora Reicher Memorial Institute of Rheumatology

    Warsaw, 02-637, Poland

  • Psoriahue Medicina Interdisciplinaria S.R.L

    CABA, C1425DKG, Argentina

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA, Netherlands

  • Ramathibodi Hospital

    Ratchathewi, 10400, Thailand

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Free Hospital

    London, NW3 2QG, United Kingdom

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • S.C. Policlinica CCBR S.R.L.

    Bucharest, 030463, Romania

  • SAPIENS - Instituto de Estudos e Pesquisa Clínica

    Curitiba, 80440-210, Brazil

  • SC Medaudio Optica SRL

    Râmnicu Vâlcea, 240762, Romania

  • STAT Research

    CABA, C1023AAB, Argentina

  • Salford Royal

    Salford, M6 8HD, United Kingdom

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Singapore General Hospital

    Singapore, 169608, Singapore

  • Songklanagarind Hospital

    Hat Yai, 90110, Thailand

  • Soonchunhyang University Hospital Seoul

    Seoul, 04401, South Korea

  • Southern California Scleroderma and Rheumatology Center

    Inglewood, California, 90301, United States

  • Sree Sudheendra Medical Mission

    Kochi, 682018,, India

  • Srinagarind Hospital

    Muang, 40002, Thailand

  • St John's Medical College

    Bangalore, 560 034, India

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6, Canada

  • St. Luke's Medical Center-Quezon-59457

    Quezon City, 1112, Philippines

  • St. Mary's Clinical Hospital

    Bucharest, 11172, Romania

  • St. Paul's Hospital (Vancouver)

    Vancouver, British Columbia, V1Y 1S1, Canada

  • TYKS

    Turku, 20521, Finland

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • The Chaim Sheba Medical Center Tel HaShomer

    Ramat Gan, 5262000, Israel

  • The Emory Clinic

    Atlanta, Georgia, 30322, United States

  • The First Affiliated Hospital Of Bengbu Medical College

    Bengbu, 233004, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315010, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310009, China

  • The University of Osaka Hospital

    Osaka, Suita, 565-0871, Japan

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • The third affiliated hospital of Sun Yat-Sen University

    Guangzhou, 510630, China

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Tianjin Medical University General Hospital

    Tianjin, 30052, China

  • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T

    Wuhan, 430030, China

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • ULB Hopital Erasme

    Brussels, 1070, Belgium

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

    Almada, 2801-951, Portugal

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University Hospital Zurich

    Zurich, 8091, Switzerland

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100, Malaysia

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Universitätsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Köln (AöR)

    Cologne, 50937, Germany

  • Waikato Hospital

    Hamilton, 3204, New Zealand

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8509, Japan

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Western Galilee Hospital

    Nahariya, 2210001, Israel

  • Westfälische Wilhelms-Universität Münster

    Münster, 48149, Germany

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Wuhan Union Hospital

    Wuhan, 430022, China

  • Yale University School of Medicine

    New Haven, Connecticut, 06519, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.