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

Description

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).

Conditions

Hidradenitis Suppurativa

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Study Overview

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Study Details

Study overview

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).

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)

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

Condition
Hidradenitis Suppurativa
Intervention / Treatment

-

Contacts and Locations

Coral Gables

Clinical Site 1002, Coral Gables, Florida, United States, 33134

Maitland

Clinical Site 1015, Maitland, Florida, United States, 32751

Tampa

Clinical Site 1013, Tampa, Florida, United States, 33613

Savannah

Clinical Site 1008, Savannah, Georgia, United States, 31419

Ft. Gratiot

Clinical Site 1007, Ft. Gratiot, Michigan, United States, 48059

Portsmouth

Clinical Site 1003, Portsmouth, New Hampshire, United States, 03801

Philadelphia

Clinical Site 1004, Philadelphia, Pennsylvania, United States, 19103

Greenville

Clinical Site 1005, Greenville, South Carolina, United States, 29615

Arlington

Clinical site 1012, Arlington, Texas, United States, 76011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Avalo Therapeutics, Inc.,

Study Record Dates

2026-07