Patient enrollment has reportedly been completed in the phase 2 LOTUS clinical trial of AVTX-009, an investigational treatment for hidradenitis suppurativa (HS).
It is one of the studies currently being conducted outside Japan.
About the trial
AVTX-009 is an investigational antibody treatment targeting interleukin-1 beta (IL-1β), a substance involved in inflammation.
The LOTUS trial is studying people with moderate to severe HS, comparing
two doses and a placebo
to evaluate safety and efficacy.
The primary outcome is HiSCR75, which assesses whether inflammatory nodules and abscesses improve by at least 75%.
Approximately 250 patients were enrolled, reportedly more than planned. The main trial results are expected in mid-2026.
What is known at this stage
This announcement concerns completion of enrollment. Results on treatment efficacy and safety are not yet available.
Research in HS is exploring several pathways involved in inflammation. Targeting IL-1β is one possibility currently under investigation.
Our perspective
Several treatment studies are continuing outside Japan.
Following these developments can help us understand what research is taking place around the world.
This article reports research progress and does not recommend a particular treatment.
Sources
Dermatology Times AVTX-009 Completes Enrollment in HS Phase 2 Trial https://www.dermatologytimes.com/view/avtx-009-completes-enrollment-in-hs-phase-2-trial
ClinicalTrials.gov NCT06603077 https://clinicaltrials.gov/study/NCT06603077
