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

April 2, 2024 updated by: Boehringer Ingelheim

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • C.a.b.a, Argentina, C1027AAP
        • Recruiting
        • Centro de Investigaciones Metabólicas (CINME)
        • Contact:
      • Caba, Argentina, C1023AAB
      • Caba, Argentina, 1280AEB
      • Caba, Argentina, C1405BFN
        • Recruiting
        • Instituto de Investigación Clínica TyT
        • Contact:
      • Caba, Argentina, C1425DKG
        • Recruiting
        • Psoriahue Medicina Interdisciplinaria S.R.L
        • Contact:
      • La Plata, Argentina, B1900AXI
      • Mar del Plata, Argentina, 7600
        • Recruiting
        • Centro de Investigaciones Médicas Mar del Plata
        • Contact:
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Liverpool, New South Wales, Australia, 2170
      • Westmead, New South Wales, Australia, 2145
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Medical University of Graz State Hospital - University Hospital Graz
        • Contact:
  • Belgium
      • Bruxelles, Belgium, 1070
      • Gent, Belgium, 9000
      • Leuven, Belgium, 3000
      • Liège, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Universitaire de Liège
        • Contact:
  • Brazil
      • Curitiba, Brazil, 80440-080
        • Recruiting
        • Edumed - Educacao e Saude SA
        • Contact:
      • Porto Alegre, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:
      • São Bernardo do Campo, Brazil, 09780-000
        • Recruiting
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos
        • Contact:
      • São Paulo, Brazil, 04023-062
        • Recruiting
        • Hospital do RIM - UNIFESP
        • Contact:
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V1Y 1S1
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Recruiting
        • St. Joseph's Healthcare Hamilton
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Contact:
  • Chile
      • Comuna De Recoleta, Chile, 8420383
        • Recruiting
        • Centro Internacional de Estudios Clínicos (CIEC)
        • Contact:
      • Vitacura, Chile, 7640881
        • Recruiting
        • Clínica Dermacross S.A.
        • Contact:
  • China
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
      • Beijing, China, 100032
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Bengbu, China, 233004
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
      • Changchun, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Chengdu, China, 610041
      • Guangzhou, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guangzhou, China, 510630
        • Recruiting
        • 3rd Affiliated Hosp of Sun yet-sen University
        • Contact:
      • Hangzhou, China, 310009
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Nanjing, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Ningbo, China, 315010
        • Recruiting
        • The first affiliated hospital of Ningbo University
        • Contact:
      • Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University
        • Contact:
      • Suzhou, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
      • Tianjin, China, 30052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
      • Wenzhou, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Med College
        • Contact:
      • Wuhan, China, 430022
        • Recruiting
        • Wuhan Union Hospital
        • Contact:
      • Wuhan, China, 430030
        • Recruiting
        • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
        • Contact:
  • Czechia
      • Prague, Czechia, 12800
        • Recruiting
        • Institute of Rheumathology Prague
        • Contact:
      • Uherske Hradiste, Czechia, 686 01
        • Recruiting
        • Medical Plus s.r.o., Rheumatology Outpatient Clinic
        • Contact:
  • Denmark
      • Aarhus N, Denmark, 8200
  • Finland
      • Kuopio, Finland, 70210
        • Recruiting
        • Kuopio University Hospital
        • Contact:
      • Turku, Finland, 20521
  • France
      • Epagny Metz-Tessy, France, 74370
      • Nantes, France, 44093
      • Paris, France, 75014
      • Rennes, France, 35003
      • Strasbourg, France, 67091
      • Toulouse, France, 31059
  • Germany
      • Berlin, Germany, 10117
        • Terminated
        • Charité - Universitätsmedizin Berlin
      • Erlangen, Germany, 91054
      • Heidelberg, Germany, 69120
      • Jena, Germany, 07747
      • Köln, Germany, 50937
      • München, Germany, 80337
      • Münster, Germany, 48149
        • Recruiting
        • Westfälische Wilhelms-Universität Münster
        • Contact:
  • Greece
      • Athens, Greece, 11527
        • Recruiting
        • General Hospital of Athens "LAIKO"
        • Contact:
      • Athens, Greece, 115 27
        • Recruiting
        • General Hospital of Athens "LAIKO"
        • Contact:
  • India
      • Bangalore, India, 560 034
        • Recruiting
        • St John's Medical College
        • Contact:
      • Kochi, India, 682018,
        • Recruiting
        • Sree Sudheendra Medical Mission
        • Contact:
      • New Delhi, India, 110029
        • Recruiting
        • All India Institute of Medical Sciences
        • Contact:
      • Pune, India, 411001
        • Recruiting
        • Grant Medical Foundation, Ruby Hall Clinic
        • Contact:
      • Secunderabad, India, 500003
        • Recruiting
        • Krishna Institute of Medical Sciences
        • Contact:
  • Ireland
      • Dublin 15, Ireland, D15 X40D
  • Israel
      • Haifa, Israel, 3109601
      • Haifa, Israel, 31048
        • Recruiting
        • Bnei Zion Medical Center, Haifa
        • Contact:
      • Kfar-Saba, Israel, 4428164
      • Nahariya, Israel, 2210001
        • Recruiting
        • Western Galilee Hospital
        • Contact:
      • Ramat Gan, Israel, 5262000
        • Recruiting
        • The Chaim Sheba Medical Center Tel HaShomer
        • Contact:
  • Italy
      • Ancona, Italy, 60126
        • Recruiting
        • Ospedali Riuniti di Ancona
        • Contact:
      • Brescia, Italy, 25123
        • Recruiting
        • A.O. Spedali Civili di Brescia
        • Contact:
      • Firenze, Italy, 50139
        • Recruiting
        • Azienda Ospedaliera Careggi
        • Contact:
      • Genova, Italy, 16132
        • Recruiting
        • Azienda Ospedaliera San Martino
        • Contact:
      • Milano, Italy, 20132
      • Milano, Italy, 20122
        • Recruiting
        • Istituto Ortopedico G.Pini
        • Contact:
      • Modena, Italy, 41100
        • Recruiting
        • Azienda Ospedaliera Policlinico di Modena
        • Contact:
      • Roma, Italy, 00161
        • Recruiting
        • AOU Policlinico Umberto I
        • Contact:
      • Roma, Italy, 00195
      • Roma, Italy, 00128
        • Recruiting
        • Università degli Studi Campus Bio-Medico
        • Contact:
  • Japan
      • Aichi, Nagoya, Japan, 457-8510
        • Recruiting
        • Japan Community Healthcare Organization Chukyo Hospital
        • Contact:
      • Aichi, Toyoake, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital
        • Contact:
      • Fukui, Yoshida-gun, Japan, 910-1193
        • Recruiting
        • University of Fukui Hospital
        • Contact:
      • Fukuoka, Kitakyushu, Japan, 807-8555
        • Recruiting
        • Hospital of the University of Occupational and Environmental Health
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8543
        • Recruiting
        • Sapporo Medical University Hospital
        • Contact:
      • Ishikawa, Kanazawa, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital
        • Contact:
      • Kyoto, Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital
        • Contact:
      • Miyagi, Sendai, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
        • Contact:
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Recruiting
        • Nagasaki University Hospital
        • Contact:
      • Osaka, Suita, Japan, 565-0871
        • Recruiting
        • Osaka University Hospital
        • Contact:
      • Osaka, Takatsuki, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital
        • Contact:
      • Tokyo, Bunkyo-ku, Japan, 113-8603
        • Recruiting
        • Nippon Medical School Hospital
        • Contact:
      • Wakayama, Wakayama, Japan, 641-8509
        • Recruiting
        • Wakayama Medical University Hospital
        • Contact:
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Korea, Republic of, 04763
        • Recruiting
        • Hanyang University Medical Center
        • Contact:
      • Seoul, Korea, Republic of, 04401
        • Recruiting
        • Soonchunhyang University Hospital Seoul
        • Contact:
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University of Malaya Medical Centre
        • Contact:
      • Selangor, Malaysia, 68100
  • Mexico
      • Chihuahua, Mexico, 31020
        • Recruiting
        • Investigacion y Biomedicina de Chihuahua S.C.
        • Contact:
      • Guadalajara, Mexico, 44160
        • Recruiting
        • Centro Integral en Reumatologia, SA. de CV.
        • Contact:
      • Merida, Mexico, 97070
        • Recruiting
        • Medical Care & Research SA de CV
        • Contact:
      • Oaxaca, Mexico, 68000
        • Recruiting
        • Oaxaca Site Management Organization, S.C.
        • Contact:
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Recruiting
        • Leids Universitair Medisch Centrum (LUMC)
        • Contact:
      • Nijmegen, Netherlands, 6525 GA
        • Recruiting
        • Radboud Universitair Medisch Centrum
        • Contact:
  • New Zealand
      • Hamilton, New Zealand, 3204
  • Philippines
      • Manila, Philippines, 1000
      • Quezon City, Philippines, 1112
  • Poland
      • Krakow, Poland, 30-002
        • Recruiting
        • Malopolska Clinical Research
        • Contact:
      • Poznan, Poland, 60-218
        • Recruiting
        • Medical Center Hetmanska
        • Contact:
      • Warsaw, Poland, 04 141
        • Recruiting
        • Military Medical Institute- National Research Institute
        • Contact:
      • Warsaw, Poland, 02-507
        • Recruiting
        • National Medical Institute MSWiA
        • Contact:
  • Romania
      • Brasov, Romania, 500283
      • Bucharest, Romania, 11172
        • Recruiting
        • St. Mary's Clinical Hospital
        • Contact:
      • Bucuresti, Romania, 30463
        • Recruiting
        • S.C. Policlinica CCBR SRL, Bucuresti
        • Contact:
      • Cluj-Napoca, Romania, 400006
        • Recruiting
        • Cluj Napoca Clinical County Hospital
        • Contact:
      • Ramnicu-Valcea, Romania, 240762
        • Suspended
        • SC Medaudio Optica SRL
  • Singapore
      • Singapore, Singapore, 169608
      • Singapore, Singapore, 308433
  • Spain
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08026
        • Recruiting
        • Hospital Santa Creu i Sant Pau
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain, 28034
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Hospital Clínico de Santiago
        • Contact:
      • Valencia, Spain, 46017
  • Sweden
      • Göteborg, Sweden, 413 45
        • Recruiting
        • Clinical Rheumatology Research Center Sahlgrenska
        • Contact:
  • Switzerland
      • St. Gallen, Switzerland, 9007
  • Taiwan
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
        • Contact:
      • Taipei, Taiwan, 10016
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakom Chiangmai Hospital
        • Contact:
      • Hat Yai, Thailand, 90110
        • Recruiting
        • Songklanagarind Hospital
        • Contact:
      • Muang, Thailand, 40002
        • Recruiting
        • Srinagarind Hospital
        • Contact:
      • Ratchathewi, Thailand, 10400
        • Recruiting
        • Ramathibodi Hospital
        • Contact:
  • Turkey
      • Elazig, Turkey, 23200
  • United Kingdom
      • Leeds, United Kingdom, LS7 4SA
      • Liverpool, United Kingdom, L9 7AL
      • London, United Kingdom, NW3 2QG
      • Salford, United Kingdom, M6 8HD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
    • Arizona
      • Scottsdale, Arizona, United States, 85259
    • California
      • Covina, California, United States, 91722
      • Los Angeles, California, United States, 90095
      • Whittier, California, United States, 90602
    • Connecticut
      • New Haven, Connecticut, United States, 06519
    • Florida
      • Gainesville, Florida, United States, 32610
      • Jacksonville, Florida, United States, 32224
      • Plantation, Florida, United States, 33324
    • Georgia
      • Atlanta, Georgia, United States, 30322
      • Augusta, Georgia, United States, 30912
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • New York
      • Brooklyn, New York, United States, 11203
        • Recruiting
        • New York City Health and Hospitals/Kings County
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45219
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Recruiting
        • Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: Avenciguat (BI 685509)
Drug: Avenciguat (BI 685509)
Avenciguat (BI 685509)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of decline in forced vital capacity (FVC) (mL) over 48 weeks
Time Frame: 48 weeks.
48 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score at Week 48
Time Frame: At baseline and 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.
At baseline and at week 48.
Absolute change from baseline in forced vital capacity (FVC) (% predicted) at Week 48
Time Frame: At baseline and at week 48.
At baseline and at week 48.
Absolute change from baseline in the Patient Global Assesment (PGA) Visual Analog Scale (VAS) score at Week 48
Time Frame: At baseline and 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.
At baseline and at week 48.
Absolute change from baseline in the Clinician Global Assessment (CGA) Visual Analog Scale (VAS) score at Week 48
Time Frame: At baseline and 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.
At baseline and at week 48.
Composite measure of Raynaud's phenomenon (RP) activity at Week 48
Time Frame: Week 48.
Week 48.
Absolute change from baseline in Digital ulcer (DU) net burden at Week 48
Time Frame: At baseline and at week 48.
At baseline and at week 48.
Time to treatment failure
Time Frame: 48 weeks.

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)
48 weeks.
Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 48
Time Frame: At week 48.
At week 48.
Absolute change from baseline in Modified Rodnan Skin Score (mRSS) at Week 48 in study participants with diffuse cutaneous systemic sclerosis (dcSSc)
Time Frame: At baseline and at week 48.
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).
At baseline and at week 48.
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
Time Frame: At baseline and 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.
At baseline and at week 48.
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
Time Frame: 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.
At week 48.
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)
Time Frame: 48 weeks.
48 weeks.
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)
Time Frame: 48 weeks.
48 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2022

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

November 28, 2025

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

September 26, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1366-0031
  • 2022-500332-11-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Scleroderma, Systemic

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe