BI 685509 for Systemic Sclerosis (VITALISScE™ Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Boehringer Ingelheim

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a medicine called Avenciguat to see if it helps adults with a condition called scleroderma, which affects the skin and internal organs. Participants take the medicine for several months. The study checks if the medicine improves lung function and other symptoms.

Eligibility Criteria

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.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Avenciguat (BI 685509)Experimental Treatment1 Intervention

Avenciguat (BI 685509)

Group II: PlaceboPlacebo Group1 Intervention

Placebo