BI 685509 for Systemic Sclerosis

(VITALISScE™ Trial)

Not currently recruiting at 253 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Disqualifiers: Pulmonary hypertension, Pulmonary disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Avenciguat (BI 685509) can help people with scleroderma who have lung fibrosis or blood vessel issues. Scleroderma, also known as systemic sclerosis, causes the skin and sometimes internal organs to become hard and tight. Participants join one of two groups: one takes Avenciguat, and the other takes a placebo (a pill with no medicine). The trial seeks individuals diagnosed with a specific form of scleroderma, either diffuse cutaneous or limited cutaneous with certain antibodies, who experience lung or blood vessel symptoms. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Avenciguat (BI 685509) is being tested for safety and effectiveness in people with systemic sclerosis, a type of scleroderma. This treatment has been administered to individuals with systemic sclerosis before, and researchers are studying their tolerance. They examine the frequency and severity of side effects.

Results so far suggest that Avenciguat is generally well-tolerated, with most individuals not experiencing severe side effects. However, like any medication, some may experience mild reactions. Common issues to watch for include headaches or an upset stomach, though specific details from the studies aren't provided here.

As this trial is in its early stages, safety and side effects remain under close observation. Participants will have regular check-ups with doctors to manage any potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for scleroderma?

Unlike the standard treatments for systemic sclerosis, which often include immunosuppressants and anti-fibrotic drugs, Avenciguat (BI 685509) offers a novel approach by targeting the nitric oxide signaling pathway. This mechanism aims to improve blood flow and reduce tissue fibrosis, which are key challenges in managing systemic sclerosis. Researchers are excited about Avenciguat because it could potentially address both vascular and fibrotic complications simultaneously, offering a more comprehensive treatment option for patients.

What evidence suggests that Avenciguat (BI 685509) might be an effective treatment for scleroderma?

In this trial, participants will receive either Avenciguat (BI 685509) or a placebo. Research has shown that Avenciguat might help people with systemic sclerosis, also known as scleroderma, particularly those with lung scarring or blood vessel problems. This treatment activates a specific enzyme in the body, improving blood flow and reducing symptoms. Early results suggest it might outperform some current treatments for scleroderma. Specifically, previous patients demonstrated possible improvements in lung function and overall health. The medicine is being tested to determine if these benefits are consistent for more people. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 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.

Exclusion Criteria

I have been diagnosed with pulmonary hypertension.

I have cirrhosis.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take Avenciguat (BI 685509) or placebo tablets 3 times a day for at least 11 months

48 weeks

Visits every 2 weeks initially, then less frequent

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Visits every 3 months

Open-label extension (optional)

Participants may continue to take the tablets until the last participant has completed the 11-month treatment period

Variable

What Are the Treatments Tested in This Trial?

Interventions

• BI 685509
• Placebo

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

In a phase II study involving patients with systemic sclerosis (SSc), tocilizumab treatment for 48 weeks led to a significant improvement in skin scores and stabilization of lung function, as measured by the modified Rodnan Skin Score (mRSS) and forced vital capacity (%pFVC).

While tocilizumab was associated with an increased rate of serious infections compared to placebo, no new safety concerns were identified, suggesting that while the drug is effective, monitoring for infections is important during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate). Khanna, D., Denton, CP., Lin, CJF., et al.[2019]

Several promising drugs, including rituximab and tocilizumab, are currently in phase III clinical trials for treating systemic sclerosis, which is a positive development for patients with this challenging condition.

The involvement of multiple company-sponsored trials indicates increasing interest and investment in finding effective treatments for systemic sclerosis, suggesting that there is hope for improved patient outcomes in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic sclerosis phase III clinical trials: Hope on the horizon? Aringer, M., Denton, CP.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05559580

NCT05559580 | A Study in People With Systemic Sclerosis ... The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11559521/

A Phase II study of avenciguat, a novel soluble guanylate ... Conclusions: The VITALISScE™ study is assessing the efficacy, safety and tolerability of avenciguat in patients with active systemic sclerosis ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05559580?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(%22Scleroderma,%20Systemic%22))&rank=5

A Study in People With Systemic Sclerosis to Test Whether ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. ard.bmj.com ard.bmj.com/content/82/Suppl_1/583

POS0620 BI 685509: A POTENT ACTIVATOR OF ... Conclusion Collectively, these results point to the use of the sGC activator BI 685509 as a novel treatment for SSc and suggests potential superior effects vs.

5. trials.arthritis.org trials.arthritis.org/trials/NCT05559580

A Study in People With Systemic Sclerosis to Test Whether ... The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis ...

6. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT05559580

A Study in People With Systemic Sclerosis to Test Whether ... Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can ...