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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 10 February 2025
Main ID:  NCT05559580
Date of registration: 26/09/2022
Prospective Registration: Yes
Primary sponsor: Boehringer Ingelheim
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 VITALISScEā„¢
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
Date of first enrolment: December 13, 2022
Target sample size: 188
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/ct2/show/NCT05559580
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Argentina Australia Austria Belgium Brazil Canada Chile China
Czechia Denmark Finland France Germany Greece India Ireland
Israel Italy Japan Korea, Republic of Malaysia Mexico Netherlands New Zealand
Norway Philippines Poland Portugal Romania Singapore Spain Sweden
Switzerland Taiwan Thailand Turkey United Kingdom United States
Contacts
Key inclusion & exclusion criteria
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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Scleroderma, Systemic
Intervention(s)
Drug: Placebo
Drug: Avenciguat (BI 685509)
Primary Outcome(s)
Rate of decline in forced vital capacity (FVC) (mL) over 48 weeks [Time Frame: 48 weeks.]
Secondary Outcome(s)
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.]
Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 48 [Time Frame: 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.]
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.]
Absolute change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score at Week 48 [Time Frame: At baseline and 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.]
Absolute change from baseline in forced vital capacity (FVC) (% predicted) at Week 48 [Time Frame: At baseline and at week 48.]
Absolute change from baseline in Digital ulcer (DU) net burden at Week 48 [Time Frame: At baseline and 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.]
Composite measure of Raynaud's phenomenon (RP) activity at Week 48 [Time Frame: 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.]
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.]
Time to treatment failure [Time Frame: 48 weeks.]
Secondary ID(s)
2022-500332-11-00
1366-0031
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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