What side effects are associated with this type of intervention?

Common treatments for systemic scleroderma, particularly those involving soluble guanylate cyclase (sGC) stimulators like Avenciguat (BI 685509), can have side effects including headache, dizziness, hypotension, and gastrointestinal issues such as nausea. Other vasodilators, such as calcium channel blockers (e.g., nifedipine), may cause ankle swelling, flushing, and headache. Patients should discuss these potential side effects with their healthcare providers to ensure effective management of their condition.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting soluble guanylate cyclase (sGC) for Systemic Scleroderma. However, treatments for Systemic Scleroderma often focus on managing symptoms such as lung fibrosis and vascular issues. FDA-approved drugs for these symptoms include immunosuppressants like mycophenolate mofetil and cyclophosphamide, and endothelin receptor antagonists like bosentan for pulmonary arterial hypertension. Broader treatment approaches also include the use of anti-fibrotic agents and vasodilators to manage the disease's systemic effects.

What other types of research exist?

Promising alternatives to Avenciguat (BI 685509) for systemic scleroderma patients include Sildenafil (a phosphodiesterase-5 inhibitor) and Bosentan (an endothelin-1 receptor antagonist). These medications have shown beneficial effects in improving symptoms related to vascular issues and peripheral artery disease in systemic sclerosis patients.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks.

Summary

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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)

Absolute change from baseline in the Clinician Global Assessment (CGA) Visual Analog Scale (VAS) score at Week 48

+4 more

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Soluble guanylate cyclase (sGC) stimulators, such as Avenciguat (BI 685509), work by enhancing the enzyme sGC, which increases the levels of cyclic guanosine monophosphate (cGMP). This leads to vasodilation and improved blood flow, which can help alleviate symptoms related to vascular problems in Systemic Scleroderma. Other common treatments include immunosuppressants like methotrexate (MTX) and mycophenolate mofetil (MMF), which reduce immune system activity to decrease skin thickening and organ involvement. These mechanisms are crucial for Systemic Scleroderma patients as they target the underlying pathophysiology of the disease, potentially improving quality of life and slowing disease progression.

Regional intravenous ketanserin and guanethidine therapy in Raynaud's phenomenon.Treatment of Raynaud's phenomenon with ketanserin, a selective antagonist of the serotonin2 (5-HT2) receptor.[Pharmacology of Raynaud's phenomenon].