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

Last updated: February 19, 2025
Sponsor: Avalo Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Acne Inversa

Hidradenitis Suppurativa

Rosacea

Treatment

AVTX-009 Regimen 1

Placebo

AVTX-009 Regimen 2

Clinical Study ID

NCT06603077
AVTX-009-HS-201
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signs and symptoms of hidradenitis suppurativa (HS) for at least 6 months prior toScreening.

  2. At least 5 inflammatory lesions in at least 2 distinct anatomical areas, at least 1of which is Hurley Stage 2 or 3.

Exclusion

Exclusion Criteria:

  1. Has a draining fistula count of ≥ 20.

  2. Has another active skin inflammatory condition, infection (viral, bacterial, orfungal), or another active ongoing inflammatory disease (other than HS) thatrequires treatment with a prohibited medication, which could interfere with theassessment of HS.

  3. History of chronic or recurrent infectious disease, including but not limited tochronic 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.

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: AVTX-009 Regimen 1
Phase: 2
Study Start date:
September 16, 2024
Estimated Completion Date:
July 31, 2026

Study 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 for 7 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.

Connect with a study center

  • Clinical Site 1203

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Clinical Site 1103

    Barrie, Ontario L4M 7G1
    Canada

    Active - Recruiting

  • Clinical Site 1104

    Hamilton, Ontario L8L 3C3
    Canada

    Active - Recruiting

  • Clinical Site 1107

    London, Ontario N6A 2C2
    Canada

    Active - Recruiting

  • Clinical Site 1106

    Toronto, Ontario M2N 3A6
    Canada

    Active - Recruiting

  • Clinical Site 1101

    Saskatoon, Saskatchewan S7K 2C1
    Canada

    Active - Recruiting

  • Clinical Site 1022

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Clinical Site 1026

    Tucson, Arizona 85704
    United States

    Active - Recruiting

  • Clinical Site 1019

    Pomona, California 91767
    United States

    Active - Recruiting

  • Clinical Site 1009

    Sacramento, California 95815
    United States

    Active - Recruiting

  • Clinical Site 1002

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Clinical Site 1015

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Clinical Site 1013

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Clinical Site

    Savannah, Georgia 31419
    United States

    Active - Recruiting

  • Clinical Site 1008

    Savannah, Georgia 31419
    United States

    Active - Recruiting

  • Clinical Site 1014

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • Clinical Site 1028

    West Lafayette, Indiana 47906
    United States

    Active - Recruiting

  • Clinical Site 1024

    Murray, Kentucky 42071
    United States

    Active - Recruiting

  • Clinical Site

    Ft. Gratiot, Michigan 48059
    United States

    Active - Recruiting

  • Clinical Site 1007

    Ft. Gratiot, Michigan 48059
    United States

    Active - Recruiting

  • Clinical Site 1003

    Portsmouth, New Hampshire 03801
    United States

    Active - Recruiting

  • Clinical Site 1016

    New York, New York 10003
    United States

    Active - Recruiting

  • Clinical Site 1020

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Clinical Site 1017

    Dublin, Ohio 43016
    United States

    Active - Recruiting

  • Clinical Site 1004

    Philadelphia, Pennsylvania 19103
    United States

    Active - Recruiting

  • Clinical Site 1018

    Johnston, Rhode Island 02919
    United States

    Active - Recruiting

  • Clinical Site

    Greenville, South Carolina 29615
    United States

    Active - Recruiting

  • Clinical Site 1005

    Greenville, South Carolina 29615
    United States

    Active - Recruiting

  • Clinical site 1012

    Arlington, Texas 76011
    United States

    Active - Recruiting

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