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

a study on Hidradenitis Suppurativa

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Northridge 5377985, California 5332921 and other locations
Dates
study started
study ends around
Principal Investigator
by April W. Armstrong, MD, MPH
Headshot of April W. Armstrong
April W. Armstrong

Description

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).

Official Title

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)

Details

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.

Keywords

Hidradenitis Suppurativa, HS, acne inversa, AVTX-009, LY2189102, FL-101, Counterfeit Drugs, AVTX-009 Regimen 1, AVTX-009 Regimen 2

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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

  • Clinical Site 1032 accepting new patients
    Northridge 5377985 California 5332921 91325 United States
  • Clinical Site 1019 accepting new patients
    Pomona 5384170 California 5332921 91767 United States

Lead Scientist at UCLA

  • April W. Armstrong, MD, MPH
    Dr. April Armstrong is Professor and Chief of Dermatology at University of California Los Angeles (UCLA). She oversees and leads the dermatology division, including managing clinical operations and promoting research and education. She also serves as Co-Director for Network Resources at the UCLA Clinical and Translational Research Institute.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Avalo Therapeutics, Inc.
Links
Sign up for this study
ID
NCT06603077
Phase
Phase 2 Hidradenitis Suppurativa Research Study
Study Type
Interventional
Participants
Expecting 222 study participants
Last Updated
Contact us about this trial