BI 685509 for Systemic Sclerosis

(VITALISScE™ Trial)

Recruiting at 210 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

188 Participants Needed

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.

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.

What makes the drug BI 685509 unique for treating systemic sclerosis?

BI 685509 is unique because it is being specifically tested for systemic sclerosis, a condition with limited effective treatments, and it may offer a novel approach compared to traditional therapies like immunosuppressants and biologicals, which have variable efficacy and side effects. ^{1 2 3 4 5}

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.

Timeline

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

Treatment Details

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.

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Recent advances in the treatment of systemic sclerosis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Rationally-based therapeutic disease modification in systemic sclerosis: Novel strategies. [2021]

3. England 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). [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Immunotherapy of systemic sclerosis. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Systemic sclerosis phase III clinical trials: Hope on the horizon? [2022]