BI 685509 for Systemic Sclerosis

(VITALISScE™ Trial)

Recruiting at210 trial locations

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.

Research Team

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.

Inclusion Criteria

Patients must fulfill the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for Systemic sclerosis (SSc)

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.

Exclusion Criteria

I have been diagnosed with pulmonary hypertension.

I have cirrhosis.

My lung function is less than half of what it should be.

Treatment Details

Interventions

• BI 685509 (Unknown)
• Placebo (Unknown)

Trial Overview 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.

Participant Groups

Group I: Avenciguat (BI 685509) Experimental Treatment 1 Intervention

Avenciguat (BI 685509)

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+