NCT06603077

A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa (LOTUS)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Avalo Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the efficacy and safety of AVTX-009 compared with placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).

Detailed description

This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study. Patients will be randomized to one of two AVTX-009 dose regimens or matching placebo in a 1:1:1 ratio. The study will comprise: 1. A Screening Period which will last up to 28 days. 2. A Treatment Period up to 16 weeks. 3. A Follow-up period of 6 weeks after the last dose of study drug. The maximum clinical trial duration for each participant is 24 weeks.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	AVTX-009 Regimen 1	AVTX-009 will be administered as a subcutaneous injection every 4 weeks.
DRUG	AVTX-009 Regimen 2	AVTX-009 will be administered as a subcutaneous injection every 2 weeks.
DRUG	Placebo	Matching placebo will be administered as a subcutaneous injection every 2 weeks.

Timeline

• Start date: 2024-09-16
• Primary completion: 2026-02-23
• Completion: 2026-04-01
• First posted: 2024-09-19
• Last updated: 2026-03-25

Locations

89 sites across 13 countries: United States, Australia, Bulgaria, Canada, Czechia, France, Germany, Greece, Italy, Poland, Slovakia, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study