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ACTIVE_NOT_RECRUITINGPHASE2

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)

NCT06603077•Avalo Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signs and symptoms of hidradenitis suppurativa (HS) for at least 6 months prior to Screening.
•2. At least 5 inflammatory lesions in at least 2 distinct anatomical areas, at least 1 of which is Hurley Stage 2 or 3.

Exclusion Criteria

•1. Has a draining fistula count of ≥ 20.
•2. Has another active skin inflammatory condition, infection (viral, bacterial, or fungal), or another active ongoing inflammatory disease (other than HS) that requires treatment with a prohibited medication, which could interfere with the assessment of HS.
•3. History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic lung infection, recurrent urinary tract infection, or open, draining or infected skin wounds or ulcers (not related to HS).
•4. Has severe, progressive and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or immunosuppressive disease.

Locations (89)

Clinical Site 1022

Scottsdale, Arizona, United States

Clinical Site 1037

Scottsdale, Arizona, United States

Clinical Site 1026

Tucson, Arizona, United States

Clinical Site 1032

Northridge, California, United States

Clinical Site 1019

Pomona, California, United States

Clinical Site 1009

Sacramento, California, United States

Clinical Site 1034

Santa Monica, California, United States

Clinical Site 1011

Washington D.C., District of Columbia, United States

Clinical Site 1029

Boca Raton, Florida, United States

Clinical Site 1002

Coral Gables, Florida, United States

Key Dates

Start Date

September 16, 2024

Primary Completion Date

March 1, 2026

Completion Date

April 1, 2026

Last Updated

November 13, 2025

Enrollment

250

ESTIMATED participants

Conditions

Hidradenitis Suppurativa

Interventions

AVTX-009 Regimen 1

DRUG

AVTX-009 Regimen 2

DRUG

Placebo

DRUG

A Study With CIT-013 in HS Patients

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study With CIT-013 in HS Patients

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

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