← Back to Search

Unknown

BI 685509 for Systemic Sclerosis (VITALISScE™ Trial)

Phase 2
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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, New skin involvement or worsening of two new body areas within 6 months of Visit 1, New involvement or worsening of one new body area if either chest or abdomen within 6 months of Visit 1, Worsening of skin thickening (e.g. ≥2 mRSS points) within 6 months of Visit 1, ≥1 tendon friction rub
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48.
Awards & highlights

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.

Who is the study for?
Adults aged 18+ with early systemic sclerosis, specifically diffuse cutaneous SSc, can join this trial. They must have active disease signs, significant vasculopathy or ILD diagnosis if other criteria aren't met. Participants need elevated biomarkers and should be within 5 years of their first non-Raynaud's symptom.Check my eligibility
What is being tested?
The study tests BI 685509 against a placebo to see if it improves lung function and scleroderma symptoms in patients with lung fibrosis or vascular issues. Patients are randomly assigned to take either the medication or placebo tablets for at least 11 months and are monitored regularly.See study design
What are the potential side effects?
While specific side effects of BI 685509 aren't listed here, participants will be closely monitored for any unwanted effects throughout the study during regular health checks.

VITALISScE™ Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.
Select...
My condition has worsened or started recently, affecting my skin or certain body areas.

VITALISScE™ Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48.
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of decline in forced vital capacity (FVC) (mL) over 48 weeks
Secondary outcome measures
Duane Retraction Syndrome
Absolute change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score 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)
+10 more

VITALISScE™ Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Avenciguat (BI 685509)Experimental Treatment1 Intervention
Avenciguat (BI 685509)
Group II: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,497 Previous Clinical Trials
11,339,243 Total Patients Enrolled

Media Library

BI 685509 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05559580 — Phase 2
Systemic Scleroderma Research Study Groups: Avenciguat (BI 685509), Placebo
Systemic Scleroderma Clinical Trial 2023: BI 685509 Highlights & Side Effects. Trial Name: NCT05559580 — Phase 2
BI 685509 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05559580 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~109 spots leftby Oct 2025