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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05559580




Registration number
NCT05559580
Ethics application status
Date submitted
26/09/2022
Date registered
29/09/2022

Titles & IDs
Public title
A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms
Scientific title
A Phase II, Randomised, Placebo-controlled, Double-blind, Parallel Group, Efficacy and Safety Study of at Least 48 Weeks of Oral BI 685509 Treatment in Adults With Progressive Systemic Sclerosis
Secondary ID [1] 0 0
2022-500332-11-00
Secondary ID [2] 0 0
1366-0031
Universal Trial Number (UTN)
Trial acronym
VITALISScE™
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Scleroderma, Systemic 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avenciguat (BI 685509)
Treatment: Drugs - Placebo

Experimental: Avenciguat (BI 685509) - Avenciguat (BI 685509)

Placebo comparator: Placebo - Placebo


Treatment: Drugs: Avenciguat (BI 685509)
Avenciguat (BI 685509)

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of decline in forced vital capacity (FVC) (mL) over 48 weeks
Timepoint [1] 0 0
48 weeks.
Secondary outcome [1] 0 0
Absolute change from baseline in Modified Rodnan Skin Score (mRSS) at Week 48 in study participants with diffuse cutaneous systemic sclerosis (dcSSc)
Timepoint [1] 0 0
At baseline and at week 48.
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
At baseline and at week 48.
Secondary outcome [3] 0 0
Absolute change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score at Week 48
Timepoint [3] 0 0
At baseline and at week 48.
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
At week 48.
Secondary outcome [5] 0 0
Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 48
Timepoint [5] 0 0
At week 48.
Secondary outcome [6] 0 0
Absolute change from baseline in forced vital capacity (FVC) (% predicted) at Week 48
Timepoint [6] 0 0
At baseline and at week 48.
Secondary outcome [7] 0 0
Absolute change from baseline in the Patient Global Assesment (PGA) Visual Analog Scale (VAS) score at Week 48
Timepoint [7] 0 0
At baseline and at week 48.
Secondary outcome [8] 0 0
Absolute change from baseline in the Clinician Global Assessment (CGA) Visual Analog Scale (VAS) score at Week 48
Timepoint [8] 0 0
At baseline and at week 48.
Secondary outcome [9] 0 0
Composite measure of Raynaud's phenomenon (RP) activity at Week 48
Timepoint [9] 0 0
Week 48.
Secondary outcome [10] 0 0
Absolute change from baseline in Digital ulcer (DU) net burden at Week 48
Timepoint [10] 0 0
At baseline and at week 48.
Secondary outcome [11] 0 0
Time to treatment failure
Timepoint [11] 0 0
48 weeks.
Secondary outcome [12] 0 0
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)
Timepoint [12] 0 0
48 weeks.
Secondary outcome [13] 0 0
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)
Timepoint [13] 0 0
48 weeks.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
Accrual to date
Final
188
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Argentina
State/province [11] 0 0
C.a.b.a
Country [12] 0 0
Argentina
State/province [12] 0 0
Caba
Country [13] 0 0
Argentina
State/province [13] 0 0
La Plata
Country [14] 0 0
Argentina
State/province [14] 0 0
Mar del Plata
Country [15] 0 0
Austria
State/province [15] 0 0
Graz
Country [16] 0 0
Belgium
State/province [16] 0 0
Gent
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
State/province [18] 0 0
Liège
Country [19] 0 0
Brazil
State/province [19] 0 0
Curitiba
Country [20] 0 0
Brazil
State/province [20] 0 0
São Paulo
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Chile
State/province [22] 0 0
Comuna De Recoleta
Country [23] 0 0
Chile
State/province [23] 0 0
Vitacura
Country [24] 0 0
China
State/province [24] 0 0
Beijing
Country [25] 0 0
China
State/province [25] 0 0
Changchun
Country [26] 0 0
China
State/province [26] 0 0
Chengdu
Country [27] 0 0
China
State/province [27] 0 0
Guangzhou
Country [28] 0 0
China
State/province [28] 0 0
Hangzhou
Country [29] 0 0
China
State/province [29] 0 0
Nanjing
Country [30] 0 0
China
State/province [30] 0 0
Ningbo
Country [31] 0 0
China
State/province [31] 0 0
Shanghai
Country [32] 0 0
China
State/province [32] 0 0
Suzhou
Country [33] 0 0
China
State/province [33] 0 0
Tianjin
Country [34] 0 0
China
State/province [34] 0 0
Wenzhou
Country [35] 0 0
China
State/province [35] 0 0
Wuhan
Country [36] 0 0
Czechia
State/province [36] 0 0
Prague
Country [37] 0 0
Denmark
State/province [37] 0 0
Aarhus N
Country [38] 0 0
France
State/province [38] 0 0
Epagny Metz-Tessy
Country [39] 0 0
France
State/province [39] 0 0
Nantes
Country [40] 0 0
France
State/province [40] 0 0
Paris
Country [41] 0 0
France
State/province [41] 0 0
Rennes
Country [42] 0 0
Germany
State/province [42] 0 0
Berlin
Country [43] 0 0
Germany
State/province [43] 0 0
Erlangen
Country [44] 0 0
Germany
State/province [44] 0 0
Heidelberg
Country [45] 0 0
Germany
State/province [45] 0 0
München
Country [46] 0 0
Germany
State/province [46] 0 0
Münster
Country [47] 0 0
Greece
State/province [47] 0 0
Athens
Country [48] 0 0
India
State/province [48] 0 0
Bangalore
Country [49] 0 0
India
State/province [49] 0 0
Chandigarh
Country [50] 0 0
India
State/province [50] 0 0
Kochi
Country [51] 0 0
India
State/province [51] 0 0
Kolkata
Country [52] 0 0
India
State/province [52] 0 0
Maharashtra
Country [53] 0 0
India
State/province [53] 0 0
New Delhi
Country [54] 0 0
India
State/province [54] 0 0
Pune
Country [55] 0 0
Israel
State/province [55] 0 0
Haifa
Country [56] 0 0
Israel
State/province [56] 0 0
Nahariya
Country [57] 0 0
Israel
State/province [57] 0 0
Ramat Gan
Country [58] 0 0
Italy
State/province [58] 0 0
Ancona
Country [59] 0 0
Italy
State/province [59] 0 0
Milano
Country [60] 0 0
Italy
State/province [60] 0 0
Modena
Country [61] 0 0
Italy
State/province [61] 0 0
Roma
Country [62] 0 0
Japan
State/province [62] 0 0
Aichi, Nagoya
Country [63] 0 0
Japan
State/province [63] 0 0
Fukuoka, Kitakyushu
Country [64] 0 0
Japan
State/province [64] 0 0
Hokkaido, Sapporo
Country [65] 0 0
Japan
State/province [65] 0 0
Ishikawa, Kanazawa
Country [66] 0 0
Japan
State/province [66] 0 0
Kyoto, Kyoto
Country [67] 0 0
Japan
State/province [67] 0 0
Osaka, Suita
Country [68] 0 0
Japan
State/province [68] 0 0
Tokyo, Bunkyo-ku
Country [69] 0 0
Japan
State/province [69] 0 0
Wakayama, Wakayama
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Seoul
Country [71] 0 0
Malaysia
State/province [71] 0 0
Kuala Lumpur
Country [72] 0 0
Malaysia
State/province [72] 0 0
Selangor
Country [73] 0 0
Mexico
State/province [73] 0 0
Chihuahua
Country [74] 0 0
Mexico
State/province [74] 0 0
Guadalajara
Country [75] 0 0
Mexico
State/province [75] 0 0
Merida
Country [76] 0 0
Mexico
State/province [76] 0 0
Oaxaca
Country [77] 0 0
Netherlands
State/province [77] 0 0
Leiden
Country [78] 0 0
Netherlands
State/province [78] 0 0
Nijmegen
Country [79] 0 0
New Zealand
State/province [79] 0 0
Hamilton
Country [80] 0 0
Philippines
State/province [80] 0 0
Manila
Country [81] 0 0
Philippines
State/province [81] 0 0
Quezon City
Country [82] 0 0
Poland
State/province [82] 0 0
Krakow
Country [83] 0 0
Poland
State/province [83] 0 0
Poznan
Country [84] 0 0
Poland
State/province [84] 0 0
Warsaw
Country [85] 0 0
Romania
State/province [85] 0 0
Brasov
Country [86] 0 0
Romania
State/province [86] 0 0
Bucharest
Country [87] 0 0
Romania
State/province [87] 0 0
Constanta
Country [88] 0 0
Romania
State/province [88] 0 0
Ramnicu-Valcea
Country [89] 0 0
Singapore
State/province [89] 0 0
Singapore
Country [90] 0 0
Spain
State/province [90] 0 0
Barcelona
Country [91] 0 0
Spain
State/province [91] 0 0
Madrid
Country [92] 0 0
Spain
State/province [92] 0 0
Santiago de Compostela
Country [93] 0 0
Spain
State/province [93] 0 0
Valencia
Country [94] 0 0
Sweden
State/province [94] 0 0
Göteborg
Country [95] 0 0
Switzerland
State/province [95] 0 0
St. Gallen
Country [96] 0 0
Taiwan
State/province [96] 0 0
Taichung
Country [97] 0 0
Thailand
State/province [97] 0 0
Hat Yai
Country [98] 0 0
Thailand
State/province [98] 0 0
Muang
Country [99] 0 0
Thailand
State/province [99] 0 0
Ratchathewi
Country [100] 0 0
Turkey
State/province [100] 0 0
Antalya
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Leeds
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Liverpool
Country [103] 0 0
United Kingdom
State/province [103] 0 0
London
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
clintriage.rdg@boehringer-ingelheim.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05559580