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

Primary Purpose

Scleroderma, Systemic

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 685509
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma, Systemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 fulfil 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 diffuse cutaneous SSc (widespread skin fibrosis with skin involvement proximal to elbows and/or knees) as defined by LeRoy et al.1988
  5. SSc disease onset (defined by first non-Raynaud's phenomenon (RP) symptom) must be within 5 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 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 (≥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.

  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 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 forced vital capacity (FVC) <50% of predicted
  3. Limited cutaneous SSc at screening. 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.
  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.

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Medvin Clinical ResearchRecruiting
  • Medvin Clinical ResearchRecruiting
  • Mayo Clinic - FloridaRecruiting
  • Iris Research and DevelopmentRecruiting
  • Augusta UniversityRecruiting
  • Northwestern UniversityRecruiting
  • Tufts Medical CenterRecruiting
  • Massachusetts General HospitalRecruiting
  • University of Michigan Health SystemRecruiting
  • University of Cincinnati Medical CenterRecruiting
  • Thomas Jefferson UniversityRecruiting
  • Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 OaksRecruiting
  • The University of Texas Health Science Center at HoustonRecruiting
  • Centro de Investigaciones Metabólicas (CINME)Recruiting
  • Hospital Britanico de Buenos AiresRecruiting
  • STAT ResearchRecruiting
  • Instituto de Investigación Clínica TyTRecruiting
  • Psoriahue Medicina Interdisciplinaria S.R.LRecruiting
  • Hospital Italiano de La PlataRecruiting
  • Centro de Investigaciones Médicas Mar del PlataRecruiting
  • Royal Prince Alfred HospitalRecruiting
  • Liverpool HospitalRecruiting
  • Westmead HospitalRecruiting
  • Royal Adelaide HospitalRecruiting
  • St Vincent's Hospital MelbourneRecruiting
  • Medical University of Graz State Hospital - University Hospital GrazRecruiting
  • UNIV UZ GentRecruiting
  • UZ LeuvenRecruiting
  • Centre Hospitalier Universitaire de LiègeRecruiting
  • Edumed - Educacao e Saude SARecruiting
  • Hospital de Clínicas de Porto AlegreRecruiting
  • CEMEC - Centro Multidisciplinar de Estudos ClínicosRecruiting
  • Hospital do RIM - UNIFESPRecruiting
  • St. Paul's HospitalRecruiting
  • St. Joseph's Healthcare HamiltonRecruiting
  • Centre Hospitalier de l'Universite de Montreal (CHUM)Recruiting
  • Centro Internacional de Estudios Clínicos (CIEC)Recruiting
  • Clínica Dermacross S.A.Recruiting
  • Peking Union Medical College HospitalRecruiting
  • Peking University Third HospitalRecruiting
  • The First Affiliated Hospital Of Bengbu Medical CollegeRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • West China HospitalRecruiting
  • Guangdong Provincial People's HospitalRecruiting
  • 3rd Affiliated Hosp of Sun yet-sen UniversityRecruiting
  • The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
  • Nanjing Drum Tower HospitalRecruiting
  • Ningbo First HospitalRecruiting
  • Huashan Hospital, Fudan UniversityRecruiting
  • The First Affiliated Hospital of Soochow UniversityRecruiting
  • Tianjin Medical University General HospitalRecruiting
  • The First Affiliated Hospital of Wenzhou Med CollegeRecruiting
  • Wuhan Union HospitalRecruiting
  • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & TRecruiting
  • Medical Plus s.r.o., Rheumatology Outpatient ClinicRecruiting
  • Aarhus University HospitalRecruiting
  • Kuopio University HospitalRecruiting
  • TYKSRecruiting
  • HOP Annecy-GenevoisRecruiting
  • HOP Hôtel-DieuRecruiting
  • HOP CochinRecruiting
  • HOP PontchaillouRecruiting
  • HOP CivilRecruiting
  • HOP RangueilRecruiting
  • Charité - Universitätsmedizin BerlinRecruiting
  • Universitätsklinikum ErlangenRecruiting
  • Universitätsklinikum HeidelbergRecruiting
  • Universitätsklinikum JenaRecruiting
  • Universitätsklinikum Köln (AöR)Recruiting
  • Klinikum der Universität München AÖRRecruiting
  • Westfälische Wilhelms-Universität MünsterRecruiting
  • General Hospital of Athens "Laiko"Recruiting
  • General Hospital of Athens "Laiko"Recruiting
  • Krishna Institute of Medical SciencesRecruiting
  • Bnei Zion Medical Center, HaifaRecruiting
  • Rambam Medical CenterRecruiting
  • Meir Medical CenterRecruiting
  • Western Galilee HospitalRecruiting
  • The Chaim Sheba Medical Center Tel HaShomerRecruiting
  • Ospedali Riuniti di AnconaRecruiting
  • A.O. Spedali Civili di BresciaRecruiting
  • Azienda Ospedaliera San MartinoRecruiting
  • Istituto Ortopedico G.PiniRecruiting
  • IRCCS San RaffaeleRecruiting
  • Università degli Studi Campus Bio-MedicoRecruiting
  • AOU Policlinico Umberto IRecruiting
  • Poli Univ A. GemelliRecruiting
  • Japan Community Healthcare Organization Chukyo HospitalRecruiting
  • Fujita Health University HospitalRecruiting
  • University of Fukui HospitalRecruiting
  • Hospital of the University of Occupational and Environmental HealthRecruiting
  • Sapporo Medical University HospitalRecruiting
  • Hokkaido University HospitalRecruiting
  • Kanazawa University HospitalRecruiting
  • Tohoku University HospitalRecruiting
  • Nagasaki University HospitalRecruiting
  • Osaka Medical and Pharmaceutical University HospitalRecruiting
  • Nippon Medical School HospitalRecruiting
  • Wakayama Medical University HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Soonchunhyang University Hospital SeoulRecruiting
  • Hanyang University Medical CenterRecruiting
  • University of Malaya Medical CentreRecruiting
  • Hospital SelayangRecruiting
  • Investigacion y Biomedicina de Chihuahua S.C.Recruiting
  • Centro Integral en Reumatologia, SA. de CV.Recruiting
  • Medical Care & Research SA de CVRecruiting
  • Oaxaca Site Management Organization, S.C.Recruiting
  • Leids Universitair Medisch Centrum (LUMC)Recruiting
  • Radboud Universitair Medisch CentrumRecruiting
  • Waikato HospitalRecruiting
  • Manila Doctors HospitalRecruiting
  • St. Luke's Medical CenterRecruiting
  • Malopolska Clinical ResearchRecruiting
  • Medical Center HetmanskaRecruiting
  • National Medical Institute MSWiARecruiting
  • Military Medical Institute- National Research InstituteRecruiting
  • St. Mary's Clinical HospitalRecruiting
  • S.C. Policlinica CCBR SRL, BucurestiRecruiting
  • Cluj Napoca Clinical County HospitalRecruiting
  • SC Medaudio Optica SRLRecruiting
  • Singapore General HospitalRecruiting
  • Tan Tock Seng HospitalRecruiting
  • Hospital Santa Creu i Sant PauRecruiting
  • Hospital Vall d'HebronRecruiting
  • Hospital Ramón y CajalRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Clínico de SantiagoRecruiting
  • Hospital Dr. PesetRecruiting
  • Clinical Rheumatology Research Center SahlgrenskaRecruiting
  • Kantonsspital St.GallenRecruiting
  • China Medical University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Maharaj Nakom Chiangmai HospitalRecruiting
  • Songklanagarind HospitalRecruiting
  • Srinagarind HospitalRecruiting
  • Ramathibodi HospitalRecruiting
  • Chapel Allerton HospitalRecruiting
  • Royal Free HospitalRecruiting
  • Salford Royal HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BI 685509

Placebo

Arm Description

BI 685509

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Absolute change from baseline in Modified Rodnan Skin Score (mRSS) 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).
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.
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.
American College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS) score 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.
Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 48
Absolute change from baseline in forced vital capacity (FVC) (% predicted) at Week 48
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.
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.
Composite measure of Raynaud's phenomenon (RP) activity at Week 48
Absolute change from baseline in Digital ulcer (DU) net burden at Week 48
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)

Full Information

First Posted
September 26, 2022
Last Updated
October 16, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05559580
Brief Title
A Study in People With Systemic Sclerosis to Test Whether BI 685509 Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms
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 Early Progressive Diffuse Cutaneous Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2022 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
November 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is open to adults aged 18 and older or above legal age who have early systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. Systemic sclerosis is also called scleroderma. The purpose of this study is to find out whether a medicine called 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Systemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patients, investigators, central reviewers, and everyone involved in trial conduct or analysis or with any other interest in this double-blind trial will remain blinded regarding the randomised treatment assignments until the database is declared ready for analysis according to the sponsor's Standard Operating Procedures (SOPs).
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BI 685509
Arm Type
Experimental
Arm Description
BI 685509
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
BI 685509
Intervention Description
BI 685509
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Rate of decline in forced vital capacity (FVC) (mL) over 48 weeks
Time Frame
48 weeks.
Secondary Outcome Measure Information:
Title
Absolute change from baseline in Modified Rodnan Skin Score (mRSS) at Week 48
Description
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).
Time Frame
At baseline and at week 48.
Title
Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 48
Description
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.
Time Frame
At baseline and at week 48.
Title
Absolute change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score at Week 48
Description
HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area.
Time Frame
At baseline and at week 48.
Title
American College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS) score at Week 48
Description
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.
Time Frame
At week 48.
Title
Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 48
Time Frame
At week 48.
Title
Absolute change from baseline in forced vital capacity (FVC) (% predicted) at Week 48
Time Frame
At baseline and at week 48.
Title
Absolute change from baseline in the Patient Global Assesment (PGA) Visual Analog Scale (VAS) score at Week 48
Description
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.
Time Frame
At baseline and at week 48.
Title
Absolute change from baseline in the Clinician Global Assessment (CGA) Visual Analog Scale (VAS) score at Week 48
Description
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.
Time Frame
At baseline and at week 48.
Title
Composite measure of Raynaud's phenomenon (RP) activity at Week 48
Time Frame
Week 48.
Title
Absolute change from baseline in Digital ulcer (DU) net burden at Week 48
Time Frame
At baseline and at week 48.
Title
Time to treatment failure
Description
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)
Time Frame
48 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 fulfil 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 diffuse cutaneous SSc (widespread skin fibrosis with skin involvement proximal to elbows and/or knees) as defined by LeRoy et al.1988 SSc disease onset (defined by first non-Raynaud's phenomenon (RP) symptom) must be within 5 years of Visit 1 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 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 (≥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. 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: Any known form of pulmonary hypertension Pulmonary disease with FVC <50% of predicted. at screening. Limited cutaneous SSc 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 5. 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boehringer Ingelheim
Phone
1-800-243-0127
Email
clintriage.rdg@boehringer-ingelheim.com
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Medvin Clinical Research
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Medvin Clinical Research
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Mayo Clinic - Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Iris Research and Development
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
C.a.b.a
ZIP/Postal Code
C1027AAP
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Hospital Britanico de Buenos Aires
City
Caba
ZIP/Postal Code
1280AEB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
STAT Research
City
Caba
ZIP/Postal Code
C1023AAB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Instituto de Investigación Clínica TyT
City
Caba
ZIP/Postal Code
C1405BFN
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Psoriahue Medicina Interdisciplinaria S.R.L
City
Caba
ZIP/Postal Code
C1425DKG
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Hospital Italiano de La Plata
City
La Plata
ZIP/Postal Code
B1900AXI
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Centro de Investigaciones Médicas Mar del Plata
City
Mar del Plata
ZIP/Postal Code
7600
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800271035
Email
australia@bitrialsupport.com
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800271035
Email
australia@bitrialsupport.com
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800271035
Email
australia@bitrialsupport.com
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800271035
Email
australia@bitrialsupport.com
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800271035
Email
australia@bitrialsupport.com
Facility Name
Medical University of Graz State Hospital - University Hospital Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800017900
Email
oesterreich@bitrialsupport.com
Facility Name
UNIV UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
080049616
Email
belgique@bitrialsupport.com
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
080049616
Email
belgique@bitrialsupport.com
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
080049616
Email
belgique@bitrialsupport.com
Facility Name
Edumed - Educacao e Saude SA
City
Curitiba
ZIP/Postal Code
80440-080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08008919295
Email
brasil@bitrialsupport.com
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08008919295
Email
brasil@bitrialsupport.com
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clínicos
City
São Bernardo do Campo
ZIP/Postal Code
09780-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08008919295
Email
brasil@bitrialsupport.com
Facility Name
Hospital do RIM - UNIFESP
City
São Paulo
ZIP/Postal Code
04023-062
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08008919295
Email
brasil@bitrialsupport.com
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V1Y 1S1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18336022346
Email
canada@bitrialsupport.com
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18336022346
Email
canada@bitrialsupport.com
Facility Name
Centre Hospitalier de l'Universite de Montreal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18336022346
Email
canada@bitrialsupport.com
Facility Name
Centro Internacional de Estudios Clínicos (CIEC)
City
Comuna De Recoleta
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800392345
Email
chile@bitrialsupport.com
Facility Name
Clínica Dermacross S.A.
City
Vitacura
ZIP/Postal Code
7640881
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800392345
Email
chile@bitrialsupport.com
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
The First Affiliated Hospital Of Bengbu Medical College
City
Bengbu
ZIP/Postal Code
233004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
The First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
West China Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
3rd Affiliated Hosp of Sun yet-sen University
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Ningbo First Hospital
City
Ningbo
ZIP/Postal Code
315010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
30052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
The First Affiliated Hospital of Wenzhou Med College
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Wuhan Union Hospital
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Medical Plus s.r.o., Rheumatology Outpatient Clinic
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800142046
Email
cesko@bitrialsupport.com
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
80711822
Email
danmark@bitrialsupport.com
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800918118
Email
suomi@bitrialsupport.com
Facility Name
TYKS
City
Turku
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800918118
Email
suomi@bitrialsupport.com
Facility Name
HOP Annecy-Genevois
City
Epagny Metz-Tessy
ZIP/Postal Code
74370
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
HOP Hôtel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
HOP Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
HOP Pontchaillou
City
Rennes
ZIP/Postal Code
35003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
HOP Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
HOP Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Universitätsklinikum Köln (AöR)
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Klinikum der Universität München AÖR
City
München
ZIP/Postal Code
80337
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Westfälische Wilhelms-Universität Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
General Hospital of Athens "Laiko"
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008000000092
Email
hellas@bitrialsupport.com
Facility Name
General Hospital of Athens "Laiko"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008000000092
Email
hellas@bitrialsupport.com
Facility Name
Krishna Institute of Medical Sciences
City
Secunderabad
ZIP/Postal Code
500003
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0008000501442
Email
india@bitrialsupport.com
Facility Name
Bnei Zion Medical Center, Haifa
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1809388162
Email
israel@bitrialsupport.com
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1809388162
Email
israel@bitrialsupport.com
Facility Name
Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1809388162
Email
israel@bitrialsupport.com
Facility Name
Western Galilee Hospital
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1809388162
Email
israel@bitrialsupport.com
Facility Name
The Chaim Sheba Medical Center Tel HaShomer
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1809388162
Email
israel@bitrialsupport.com
Facility Name
Ospedali Riuniti di Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
A.O. Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
Azienda Ospedaliera San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
Istituto Ortopedico G.Pini
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
IRCCS San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
Università degli Studi Campus Bio-Medico
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
AOU Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
Poli Univ A. Gemelli
City
Roma
ZIP/Postal Code
00195
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
Japan Community Healthcare Organization Chukyo Hospital
City
Aichi, Nagoya
ZIP/Postal Code
457-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Fujita Health University Hospital
City
Aichi, Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
University of Fukui Hospital
City
Fukui, Yoshida-gun
ZIP/Postal Code
910-1193
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Hospital of the University of Occupational and Environmental Health
City
Fukuoka, Kitakyushu
ZIP/Postal Code
807-8555
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Sapporo Medical University Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
060-8543
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Hokkaido University Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Kanazawa University Hospital
City
Ishikawa, Kanazawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Tohoku University Hospital
City
Miyagi, Sendai
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Nagasaki University Hospital
City
Nagasaki, Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Osaka, Takatsuki
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Nippon Medical School Hospital
City
Tokyo, Bunkyo-ku
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Wakayama Medical University Hospital
City
Wakayama, Wakayama
ZIP/Postal Code
641-8509
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0808802084
Email
namhan@bitrialsupport.com
Facility Name
Soonchunhyang University Hospital Seoul
City
Seoul
ZIP/Postal Code
04401
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0808802084
Email
namhan@bitrialsupport.com
Facility Name
Hanyang University Medical Center
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0808802084
Email
namhan@bitrialsupport.com
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800814353
Email
malaysia@bitrialsupport.com
Facility Name
Hospital Selayang
City
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800814353
Email
malaysia@bitrialsupport.com
Facility Name
Investigacion y Biomedicina de Chihuahua S.C.
City
Chihuahua
ZIP/Postal Code
31020
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Centro Integral en Reumatologia, SA. de CV.
City
Guadalajara
ZIP/Postal Code
44160
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Medical Care & Research SA de CV
City
Merida
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Oaxaca Site Management Organization, S.C.
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Leids Universitair Medisch Centrum (LUMC)
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000204613
Email
nederland@bitrialsupport.com
Facility Name
Radboud Universitair Medisch Centrum
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000204613
Email
nederland@bitrialsupport.com
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800440725
Email
newzealand@bitrialsupport.com
Facility Name
Manila Doctors Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
180084748502
Email
pilipinas@bitrialsupport.com
Facility Name
St. Luke's Medical Center
City
Quezon City
ZIP/Postal Code
1112
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
180084748502
Email
pilipinas@bitrialsupport.com
Facility Name
Malopolska Clinical Research
City
Krakow
ZIP/Postal Code
30-002
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008001218830
Email
polska@bitrialsupport.com
Facility Name
Medical Center Hetmanska
City
Poznan
ZIP/Postal Code
60-218
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008001218830
Email
polska@bitrialsupport.com
Facility Name
National Medical Institute MSWiA
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008001218830
Email
polska@bitrialsupport.com
Facility Name
Military Medical Institute- National Research Institute
City
Warsaw
ZIP/Postal Code
04 141
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008001218830
Email
polska@bitrialsupport.com
Facility Name
St. Mary's Clinical Hospital
City
Bucharest
ZIP/Postal Code
11172
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800895209
Email
romania@bitrialsupport.com
Facility Name
S.C. Policlinica CCBR SRL, Bucuresti
City
Bucuresti
ZIP/Postal Code
30463
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800895209
Email
romania@bitrialsupport.com
Facility Name
Cluj Napoca Clinical County Hospital
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800895209
Email
romania@bitrialsupport.com
Facility Name
SC Medaudio Optica SRL
City
Ramnicu-Valcea
ZIP/Postal Code
240762
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800895209
Email
romania@bitrialsupport.com
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
8001207344
Email
singapore@bitrialsupport.com
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
8001207344
Email
singapore@bitrialsupport.com
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Hospital Clínico de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Hospital Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Clinical Rheumatology Research Center Sahlgrenska
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0200880001
Email
sverige@bitrialsupport.com
Facility Name
Kantonsspital St.Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800005900
Email
suisse@bitrialsupport.com
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0809092098
Email
taiwan@bitrialsupport.com
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10016
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0809092098
Email
taiwan@bitrialsupport.com
Facility Name
Maharaj Nakom Chiangmai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800019059
Email
thai@bitrialsupport.com
Facility Name
Songklanagarind Hospital
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800019059
Email
thai@bitrialsupport.com
Facility Name
Srinagarind Hospital
City
Muang
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800019059
Email
thai@bitrialsupport.com
Facility Name
Ramathibodi Hospital
City
Ratchathewi
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800019059
Email
thai@bitrialsupport.com
Facility Name
Chapel Allerton Hospital
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com
Facility Name
Salford Royal Hospital
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com
Description
Related Info

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

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