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CompletedPhase 2

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

Key facts

Where
Arlington, Boca Raton, Boston, Bowling Green, Brooklyn, Chicago, Cincinnati, Cleveland, Coral Gables, Detroit, Dublin, Fort Gratiot, Greenville, Johnston, Maitland, Murray, New York, North Miami Beach, Northridge, Oakland, Philadelphia, Pittsburgh, Pomona, Portsmouth, Providence, Sacramento, Santa Monica, Savannah, Scottsdale, Tampa, The Bronx, Tucson, Washington D.C., and West Lafayette, United StatesSee the 36 sites
Phase
Phase 2

Where in United States

  • Arlington, TexasHospital not named in the registryNo longer taking part
  • Boca Raton, FloridaHospital not named in the registryNo longer taking part
  • Boston, MassachusettsHospital not named in the registryNo longer taking part
  • Boston, MassachusettsHospital not named in the registryNo longer taking part
  • Bowling Green, KentuckyHospital not named in the registryNo longer taking part
  • Brooklyn, New YorkHospital not named in the registryNo longer taking part
  • Chicago, IllinoisHospital not named in the registryNo longer taking part
  • Cincinnati, OhioHospital not named in the registryNo longer taking part
  • Cleveland, OhioHospital not named in the registryNo longer taking part
  • Coral Gables, FloridaHospital not named in the registryNo longer taking part
  • Detroit, MichiganHospital not named in the registryNo longer taking part
  • Dublin, OhioHospital not named in the registryNo longer taking part
  • Fort Gratiot, MichiganHospital not named in the registryNo longer taking part
  • Greenville, South CarolinaHospital not named in the registryNo longer taking part
  • Johnston, Rhode IslandHospital not named in the registryNo longer taking part
  • Maitland, FloridaHospital not named in the registryNo longer taking part
  • Murray, KentuckyHospital not named in the registryNo longer taking part
  • New YorkHospital not named in the registryNo longer taking part
  • North Miami Beach, FloridaHospital not named in the registryNo longer taking part
  • Northridge, CaliforniaHospital not named in the registryNo longer taking part
  • Oakland, MichiganHospital not named in the registryNo longer taking part
  • Philadelphia, PennsylvaniaHospital not named in the registryNo longer taking part
  • Pittsburgh, PennsylvaniaHospital not named in the registryNo longer taking part
  • Pomona, CaliforniaHospital not named in the registryNo longer taking part
  • Portsmouth, New HampshireHospital not named in the registryNo longer taking part
  • Providence, Rhode IslandHospital not named in the registryNo longer taking part
  • Sacramento, CaliforniaHospital not named in the registryNo longer taking part
  • Santa Monica, CaliforniaHospital not named in the registryNo longer taking part
  • Savannah, GeorgiaHospital not named in the registryNo longer taking part
  • Scottsdale, ArizonaHospital not named in the registryNo longer taking part
  • Scottsdale, ArizonaHospital not named in the registryNo longer taking part
  • Tampa, FloridaHospital not named in the registryNo longer taking part
  • The Bronx, New YorkHospital not named in the registryNo longer taking part
  • Tucson, ArizonaHospital not named in the registryNo longer taking part
  • Washington D.C., District of ColumbiaHospital not named in the registryNo longer taking part
  • West Lafayette, IndianaHospital not named in the registryNo longer taking part

Trial details

Who runs it
Avalo Therapeutics, Inc.
Trial code
NCT06603077EU 2024-514562-40-00
Record updated
21 April 2026
Original 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).Read full original descriptionShow less

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)

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).

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

Exclusion: 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; 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); Has severe, progressive and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or immunosuppressive disease; Has a draining fistula count of ≥ 20.

ClinicalTrials.gov NCT06603077 · EU CTIS 2024-514562-40-00