Your session is about to expire
← Back to Search
BI 685509 for Systemic Sclerosis (VITALISScE™ Trial)
VITALISScE™ Trial Summary
This trial is researching if a medicine can help people with scleroderma who have lung fibrosis or vascular problems. Participants take tablets for up to 11 months & are monitored for side effects & effectiveness.
VITALISScE™ Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVITALISScE™ Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VITALISScE™ Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I have been diagnosed with pulmonary hypertension.I have cirrhosis.My lung function is less than half of what it should be.My kidney function is very low or I am on dialysis.I have not had a scleroderma renal crisis in the last 6 months.I am 18 years or older (or meet the legal age requirement in my country).I have high levels of inflammation or lung damage markers, or my disease activity is moderate to high.I have signed and understand the consent form for this trial.I have been diagnosed with a specific type of skin condition and have tested positive for a certain antibody.I have an autoimmune disease, but it's not fibromyalgia, scleroderma-associated myopathy, or secondary Sjogren syndrome.I have severe blood vessel problems due to ulcers or have been treated for Raynaud's phenomenon.My condition has worsened or started recently, affecting my skin or certain body areas.My first symptom of diffuse cutaneous SSc was within the last 7 years, or my first symptom of limited cutaneous SSc was within the last 2 years.
- Group 1: Avenciguat (BI 685509)
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the medication BI 685509 received regulatory clearance from the FDA?
"Our team's assessment of BI 685509, which is currently undergoing Phase 2 trials with safety data but no efficacy information yet available, resulted in a score of 2."
Are there currently opportunities for individuals to enroll in this research?
"According to the data provided on clinicaltrials.gov, this medical trial is currently accepting participants. The study was initially shared with the public on November 24th 2022 and recently revised on December 28th of that same year."
To what extent is the sample size of this study?
"Indeed, the clinicaltrials.gov website confirms that this medical trial is actively enrolling participants. This study was first posted on November 24th 2022 and its details were last updated on December 28th 2022. 200 individuals are needed to participate from a single site."
Share this study with friends
Copy Link
Messenger