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AzTrials

Scleroderma, SystemicPhase 2VITALISScE™NCT05559580

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

A Phase 2 study testing Avenciguat (BI 685509) in people with Scleroderma, Systemic, run by Boehringer Ingelheim at 168 sites in 37 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Scleroderma, Systemic
What is being tested?
Avenciguat (BI 685509)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
214 participants
Where
168 sitesin 37 countries
Study dates
13 Dec 2022to 30 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 International Council on Harmonisation (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial.
  • Male or female patients aged ≥18 years at time of consent (or above legal age, e.g. United Kingdom (UK) ≥16 years).
  • Patients must fulfill the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for Systemic sclerosis (SSc).
  • 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.
  • 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.
  • Evidence of active disease, defined as having at least one of the following:
Show all 21Show fewer
  • 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
  • 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.
  • 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.

Who cannot join

  • Any known form of pulmonary hypertension.
  • Pulmonary disease with FVC <50% of predicted. at screening.
  • Other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma-associated myopathy and secondary Sjogren syndrome.
  • Diffusing capacity for carbon monoxide (DLCO) (haemoglobin corrected) <40% of predicted at screening.
  • Any history of scleroderma renal crisis within the last 6 months.
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology (CKD-EPI) formula) or on dialysis at screening.
Show all 9Show fewer
  • Cirrhosis of any Child-Pugh class (A, B or C).
  • 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.

Trial locations and contacts

168 sites in 37 countries.

168 sites in 37 countries

United States20 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • Augusta University

    Augusta, Georgia, 30912

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Medvin Clinical Research-Covina-67001

    Covina, California, 91722

  • University of Florida

    Gainesville, Florida, 32610

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Southern California Scleroderma and Rheumatology Center

    Inglewood, California, 90301

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Mayo Clinic - Florida

    Jacksonville, Florida, 32224

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Yale University School of Medicine

    New Haven, Connecticut, 06519

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Iris Research and Development

    Plantation, Florida, 33324

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Medvin Clinical Research-Whittier-69033

    Whittier, California, 90602

Other trials in United States

China16 sites

  • Peking Union Medical College Hospital

    Beijing, 100032

  • Peking University Third Hospital

    Beijing, 100191

  • The First Affiliated Hospital Of Bengbu Medical College

    Bengbu, 233004

  • The First Hospital of Jilin University

    Changchun, 130021

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • The third affiliated hospital of Sun Yat-Sen University

    Guangzhou, 510630

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310009

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315010

  • Huashan Hospital, Fudan University

    Shanghai, 200040

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006

  • Tianjin Medical University General Hospital

    Tianjin, 30052

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • Wuhan Union Hospital

    Wuhan, 430022

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

    Wuhan, 430030

Other trials in China

Italy10 sites

  • Ospedali Riuniti di Ancona

    Ancona, 60126

  • A.O. Spedali Civili di Brescia

    Brescia, 25123

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50139

  • Azienda Ospedaliera San Martino

    Genova, 16132

  • Istituto Ortopedico G.Pini

    Milan, 20122

  • Ospedale San Raffaele S.r.l.

    Milan, 20132

  • Azienda Ospedaliero-Universitaria di Modena

    Modena, 41124

  • Fondazione Policlinico Universitario Campus Bio-medico

    Roma, 00128

  • AOU Policlinico Umberto I

    Roma, 00161

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00195

Other trials in Italy

India9 sites

  • St John's Medical College

    Bangalore, 560 034

  • Post Graduate Institute of Medical Education and Research

    Chandigarh, 160012

  • Sree Sudheendra Medical Mission

    Kochi, 682018,

  • Post Graduate Institute of Medical Education and Research

    Kolkata, 700020

  • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute

    Maharashtra, 400053

  • Chopda Medicare and Research Centre Pvt Ltd

    Maharashtra, 422005

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Grant Medical Foundation, Ruby Hall Clinic

    Pune, 411001

  • Krishna Institute of Medical Sciences

    Secunderabad, 500003

Other trials in India

Japan8 sites

  • Japan Community Healthcare Organization Chukyo Hospital

    Aichi, Nagoya, 457-8510

  • Hospital of the University of Occupational and Environmental Health

    Fukuoka, Kitakyushu, 807-8555

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648

  • Kanazawa University Hospital

    Ishikawa, Kanazawa, 920-8641

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

  • The University of Osaka Hospital

    Osaka, Suita, 565-0871

  • Nippon Medical School Hospital

    Tokyo, Bunkyo-ku, 113-8603

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8509

Other trials in Japan

Romania8 sites

  • Bacau County Hospital

    Bacau, 600114

  • C.M.D.T.A. NEOMED, Brasov

    Brasov, 500283

  • Dr. Ion Cantacuzino Clinical Hospital

    Bucharest, 020475

  • S.C. Policlinica CCBR S.R.L.

    Bucharest, 030463

  • St. Mary's Clinical Hospital

    Bucharest, 11172

  • Cluj Napoca Clinical County Hospital

    Cluj-Napoca, 400006

  • Aqua Clinic (AquaMed Consulting SRL- juridic)

    Constanța, 900622

  • SC Medaudio Optica SRL

    Râmnicu Vâlcea, 240762

Other trials in Romania

Argentina7 sites

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

    C.a.b.a, 1056

  • Hospital Britanico de Buenos Aires

    CABA, 1280AEB

  • STAT Research

    CABA, C1023AAB

  • Instituto de Investigación Clínica TyT

    CABA, C1405BFN

  • Psoriahue Medicina Interdisciplinaria S.R.L

    CABA, C1425DKG

  • Hospital Italiano de La Plata

    La Plata, B1900AXI

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, 7600

Other trials in Argentina

France7 sites

  • HOP Annecy-Genevois

    Epagny Metz-Tessy, 74370

  • HOP Hôtel-Dieu

    Nantes, 44093

  • Hôpital Cochin

    Paris, 75014

  • HOP Pontchaillou

    Rennes, 35003

  • HOP Civil

    Strasbourg, 67091

  • Hôpital Rangueil - CHU de Toulouse

    Toulouse, 31059

  • HOP Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Germany6 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Universitätsklinikum Köln (AöR)

    Cologne, 50937

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Klinikum der Universität München AÖR

    München, 80337

  • Westfälische Wilhelms-Universität Münster

    Münster, 48149

Other trials in Germany

Spain6 sites

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08026

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706

  • Hospital Dr. Peset

    Valencia, 46017

Other trials in Spain

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Israel5 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Bnai Zion Medical Center, Haifa

    Haifa, 3339419

  • Meir Medical Center

    Kfar Saba, 4428164

  • Western Galilee Hospital

    Nahariya, 2210001

  • The Chaim Sheba Medical Center Tel HaShomer

    Ramat Gan, 5262000

Other trials in Israel

Poland5 sites

  • Malopolska Clinical Research

    Krakow, 30-002

  • Medical Center Hetmanska

    Poznan, 60-218

  • National Medical Institute MSWiA

    Warsaw, 02-507

  • Prof Eleonora Reicher Memorial Institute of Rheumatology

    Warsaw, 02-637

  • Military Medical Institute- National Research Institute

    Warsaw, 04 141

Other trials in Poland

Belgium4 sites

  • ULB Hopital Erasme

    Brussels, 1070

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

Other trials in Belgium

Brazil4 sites

  • SAPIENS - Instituto de Estudos e Pesquisa Clínica

    Curitiba, 80440-210

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035-903

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, 09780-000

  • Hospital do RIM - UNIFESP

    São Paulo, 04023-062

Other trials in Brazil

Canada4 sites

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

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

    Montreal, Quebec, H2X 0A9

  • Mount Sinai Hospital (Toronto)

    Toronto, Ontario, M5T 3L9

  • St. Paul's Hospital (Vancouver)

    Vancouver, British Columbia, V1Y 1S1

Other trials in Canada

Mexico4 sites

  • Investigacion y Biomedicina de Chihuahua S.C.

    Chihuahua City, 31020

  • Centro Integral en Reumatologia, SA. de CV.

    Guadalajara, 44160

  • Medical Care & Research SA de CV

    Mérida, 97070

  • Oaxaca Site Management Organization, S.C.

    Oaxaca City, 68000

Other trials in Mexico

Thailand4 sites

  • Maharaj Nakom Chiangmai Hospital

    Chiang Mai, 50200

  • Songklanagarind Hospital

    Hat Yai, 90110

  • Srinagarind Hospital

    Muang, 40002

  • Ramathibodi Hospital

    Ratchathewi, 10400

Other trials in Thailand

United Kingdom4 sites

  • Chapel Allerton Hospital

    Leeds, LS7 4SA

  • Aintree University Hospital

    Liverpool, L9 7AL

  • Royal Free Hospital

    London, NW3 2QG

  • Salford Royal

    Salford, M6 8HD

Other trials in United Kingdom

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Soonchunhyang University Hospital Seoul

    Seoul, 04401

  • Hanyang University Medical Center

    Seoul, 04763

Other trials in South Korea

Austria2 sites

  • Medical University of Graz State Hospital - University Hospital Graz

    Graz, 8036

  • Ordensklinikum Linz GmbH

    Linz, 4020

Other trials in Austria

Chile2 sites

  • Centro Internacional de Estudios Clínicos (CIEC)

    Comuna de Recoleta, 8420383

  • Clínica Dermacross S.A.

    Vitacura, 7640881

Other trials in Chile

Czechia2 sites

  • Institute of Rheumathology Prague

    Prague, 12800

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

    Uherské Hradiště, 686 01

Other trials in Czechia

Finland2 sites

  • Kuopio University Hospital

    Kuopio, 70210

  • TYKS

    Turku, 20521

Other trials in Finland

Greece2 sites

  • General Hospital of Athens "Laiko"

    Athens, 115 27

  • General Hospital of Athens "Laiko"

    Athens, 11527

Other trials in Greece

Malaysia2 sites

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Selayang

    Kuala Selangor, 68100

Other trials in Malaysia

Netherlands2 sites

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA

Other trials in Netherlands

Philippines2 sites

  • Manila Doctors Hospital

    Manila, 1000

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

    Quezon City, 1112

Other trials in Philippines

Singapore2 sites

  • Singapore General Hospital

    Singapore, 169608

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

Switzerland2 sites

  • Kantonsspital St.Gallen

    Sankt Gallen, 9007

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

Taiwan2 sites

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

Turkey (Türkiye)2 sites

  • Akdeniz Universitesi Tip Fakultesi -ANTALYA-33606

    Antalya, 07070

  • Firat University Hospital

    Elâzığ, 23200

Other trials in Turkey (Türkiye)

Denmark1 site

  • Aarhus University Hospital

    Aarhus N, 8200

Other trials in Denmark

New Zealand1 site

  • Waikato Hospital

    Hamilton, 3204

Other trials in New Zealand

Norway1 site

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, N-0372

Other trials in Norway

Portugal1 site

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

    Almada, 2801-951

Other trials in Portugal

Sweden1 site

  • Clinical Rheumatology Research Center Sahlgrenska

    Gothenburg, 413 45

Other trials in Sweden

About this study

Official title: A Phase II, Randomised, Placebo-controlled, Double-blind, Parallel Group, Efficacy and Safety Study of at Least 48 Weeks of Oral BI 685509 Treatment in Adults With Progressive Systemic Sclerosis

This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma.

The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems.

Read more

Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months.

During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects.

Being tested
Avenciguat (BI 685509), Placebo
Medical subject headings
Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avenciguat (BI 685509)Drug

    Avenciguat (BI 685509)

  • PlaceboDrug

    Placebo

Study groups in NCT05559580
Study groupRoleWhat they receive
Avenciguat (BI 685509)ExperimentalAvenciguat (BI 685509)
Receives: Drug: Avenciguat (BI 685509)
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of decline in forced vital capacity (FVC) (mL) over 48 weeks

    Measured: 48 weeks.

Secondary outcomes (13)

  1. Absolute change from baseline in Modified Rodnan Skin Score (mRSS) at Week 48 in study participants with diffuse cutaneous systemic sclerosis (dcSSc)

    To measure mRSS, skin thickness of the patient is rated by palpation using a scale of 0-3, with 0 = normal skin; 1= mild thickness; 2= moderate thickness and 3=severe thickness with an inability to pinch the skin into a fold (worst outcome).

    Measured: At baseline and at week 48.

  2. Proportion of responders in study participants with diffuse cutaneous systemic sclerosis (dcSSc) based on the revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 48

    Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 48 (Achievement of ≥ 20% improvement from baseline to week 48 in at least 3 of the 5 core set measures, except ≥ 5% in Forced Vital Capacity (FVC) percent predicted). The CRISS is a two-step composite index which includes in Step 2 the mRSS, FVC percent predicted, HAQ-DI, patient's global assessment and clinicians's global assessment. Step 1 in the ACR-CRISS version consists of the absence of significant worsening of interstitial lung disease, a new scleroderma renal crisis, left ventricular failure or pulmonary arterial hypertension. The revised version proposes that the absence of significant gastrointestinal dysmotility requiring parenteral or enteral nutrition and significant digital ischaemia requiring hospitalisation, gangrene or amputation are added to Step 1. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.

    Measured: At baseline and at week 48.

  3. Absolute change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score at Week 48

    HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area.

    Measured: At baseline and at week 48.

  4. American College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS) score in study participants with diffuse cutaneous systemic sclerosis (dcSSc) at Week 48

    The CRISS is a two-step composite index which includes in Step 2 the Modified Rodnan Skin Score (mRSS), FVC percent predicted, Health Assessment Questionnaire - Disability Index (HAQ-DI), patient's global assessment and clinicians's global assessment. Step 1 in the ACR-CRISS version consists of the absence of significant worsening of interstitial lung disease, a new scleroderma renal crisis, left ventricular failure or pulmonary arterial hypertension. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.

    Measured: At week 48.

  5. Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 48

    Measured: At week 48.

  6. Absolute change from baseline in forced vital capacity (FVC) (% predicted) at Week 48

    Measured: At baseline and at week 48.

  7. Absolute change from baseline in the Patient Global Assesment (PGA) Visual Analog Scale (VAS) score at Week 48

    The PGA is a self-assessment on the patient's overall health in the prior 1 week using a 0-10 ordinal scale, with a higher score indicating a worse outcome.

    Measured: At baseline and at week 48.

  8. Absolute change from baseline in the Clinician Global Assessment (CGA) Visual Analog Scale (VAS) score at Week 48

    Clinician assessment (CGA) on the patient's overall health in the prior 1 week using a 0-10 ordinal scale, with a higher score indicating a worst outcome.

    Measured: At baseline and at week 48.

  9. Composite measure of Raynaud's phenomenon (RP) activity at Week 48

    Measured: Week 48.

  10. Absolute change from baseline in Digital ulcer (DU) net burden at Week 48

    Measured: At baseline and at week 48.

  11. Time to treatment failure

    Time to treatment failure, defined as the time to one of the following events (whichever occurs first) occurring over the 48-week and extended treatment period:

    • death,
    • absolute decline in percent-predicted forced vital capacity (FVC) ≥10% relative to baseline,
    • ≥25% increase in Modified Rodnan Skin Score (mRSS) and an increase in mRSS of >5 points,
    • initiation or dose change of immunomodulating/immunosuppressive therapy for clinically significant deterioration of Diffuse cutaneous systemic sclerosis (dcSSc)

    Measured: 48 weeks.

  12. Time to Modified Rodnan Skin Score (mRSS) progression (≥25% increase in mRSS and an increase in mRSS of >5 points) in study participants with diffuse cutaneous systemic sclerosis (dcSSc)

    Measured: 48 weeks.

  13. Proportion of study participants with diffuse cutaneous systemic sclerosis (dcSSc) with Modified Rodnan Skin Score (mRSS) progression (25% increase in mRSS and an increase in mRSS of >5 points)

    Measured: 48 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2022
  2. Study start13 Dec 2022
  3. Primary completion22 Oct 2025
  4. Study completion30 Jan 2026

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05559580
Sponsor's protocol ID
1366-0031
Other IDs
2022-500332-11-00
Acronym
VITALISScE™
Status last verified
Mar 2026
First submitted
26 Sep 2022
Last updated
17 Mar 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.clinicalstudies.boehringer-ingelheim.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.

Publications

  • Kaufman J, Nabozny G, Tran-Manh C, Liebel C, Zhou X, Daley LA, Wang CT, Ebenezer DL, Delic D, Wohnhaas CT, Trinh-Minh T, Distler JHW. Avenciguat: a novel soluble guanylate cyclase activator that affects multiple cell types to inhibit IFN-1 signalling and fibrosis. Rheumatology (Oxford). 2025 Aug 1;64(8):4738-4743. doi: 10.1093/rheumatology/keaf109.

    PubMed 39985455

  • Khanna D, de Vries-Bouwstra J, Hoffmann-Vold AM, Kuwana M, Low AHL, Proudman S, Flack M, Kukreja A, Fagan N, Distler O. A Phase II study of avenciguat, a novel soluble guanylate cyclase activator, in patients with systemic sclerosis: Study design and rationale of the VITALISScE study. J Scleroderma Relat Disord. 2024 Nov 7;10(1):27-35. doi: 10.1177/23971983241291923. eCollection 2025 Feb.

    PubMed 39544899

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avenciguat (BI 685509) in people with Scleroderma, Systemic, run by Boehringer Ingelheim at 168 sites in 37 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 21 inclusion and 9 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: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 168 sites in United States, China, Italy, India, Japan and 32 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of decline in forced vital capacity (FVC) (mL) over 48 weeks (time frame: 48 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05559580, which also lists 2 linked publications.

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 17 Mar 2026.

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