Experimental liquid drug tested in ventilator patients with rare lung bleeding disease

NCT ID NCT07556484

Disease control Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This early study tests whether a liquid form of the drug avacopan can be safely given through a feeding tube to critically ill patients with ANCA vasculitis who have severe lung bleeding and need a ventilator. The main goal is to measure how the drug levels change in the blood over 72 hours. Only 6 participants will be enrolled at Mayo Clinic.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: avacopan (Tavneos)
What this could lead to: If it works, this could point toward a way to give avacopan to very sick patients who cannot swallow pills, potentially helping control severe lung inflammation.
What could go wrong: This is a tiny, early-phase study with only 6 participants, so results may not apply broadly. The drug is given in an experimental liquid form, and its safety and effectiveness in this setting are not yet known.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 6 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Fulfillment of the definitions of the Second Chapel Hill Consensus Conference for ANCA-associated vasculitis (either granulomatosis with polyangiitis (GPA) or microscopic polyangiitis MPA). * Positivity for ANCA, directed against PR3 or MPO. * Diffuse alveolar hemorrhage. * Respiratory failure requiring mechanical ventilation. * Severe newly diagnosed disease or severe relapsing disease. Severe new or relapsing disease is defined as at least one major BVAS/WG item or a score ≥ 3 and the investigator deems standard treatment for severe disease is necessary. * Minimum BVAS-WG of 3. * Requirement of standard-of-care remission induction therapy for active severe ANCA-associated vasculitis (GPA or MPA). Exclusion Criteria * Diagnosis with eosinophilic granulomatosis with polyangiitis (EGPA, formally Churg-Strauss syndrome) as defined by the Chapel Hill consensus conference. * Allergies: History of severe allergic reaction to avacopan * History of documented anti-glomerular basement membrane disease (anti-GBM disease) * Previous administration of avacopan within the last 5 days. * Concomitant use of a strong CYP3A4 inhibitor. * Aspartate aminotransferase \[AST\], alanine amino transferase \[ALT\], alkaline phosphatase, or total bilirubin elevation \>2.5 times the upper limit of normal (unless attributed to vasculitis) on routine liver function testing obtained within 3 days prior to anticipated treatment with avacopan. * Evidence of prior active or current Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency (HIV) infection. * Active serious infection, including localized infection. * Pregnancy and breastfeeding

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Conditions

The condition(s) this trial relates to.

anti-neutrophil cytoplasmic antibody-associated vasculitis diffuse alveolar hemorrhage granulomatosis with polyangiitis microscopic polyangiitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antineutrophil cytoplasmic antibody positive vasculitis Diffuse alveolar hemorrhage

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Experimental liquid drug tested in ventilator patients with rare lung bleeding disease

What the study statuses mean