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Evaluating AVTX-009 for treating 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)

Phase 2 Interventional Avalo Therapeutics, Inc. · NCT06603077

This study is testing a new treatment called AVTX-009 to see if it can help people with moderate to severe Hidradenitis Suppurativa feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorAvalo Therapeutics, Inc. Industry-sponsored
Locations55 sites (Scottsdale, Arizona and 54 other locations)
Trial IDNCT06603077 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of AVTX-009 in patients suffering from moderate to severe Hidradenitis Suppurativa (HS). It is designed as a randomized, double-blind, placebo-controlled study where participants will be assigned to one of two dosing regimens of AVTX-009 or a matching placebo. The study includes a screening period of up to 28 days, a treatment phase lasting up to 16 weeks, and a follow-up period of 6 weeks after the last dose. The total duration for each participant will be 24 weeks.

Who should consider this trial

Good fit: Ideal candidates are individuals with moderate to severe Hidradenitis Suppurativa who have experienced symptoms for at least 6 months and have a specific number of inflammatory lesions.

Not a fit: Patients with severe comorbid conditions or other active inflammatory diseases that require prohibited medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of Hidradenitis Suppurativa, providing relief for patients with moderate to severe symptoms.

How similar studies have performed: Previous studies have shown promise in treating Hidradenitis Suppurativa with similar approaches, but the specific efficacy of AVTX-009 is still being evaluated.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Scottsdale, Arizona and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hidradenitis SuppurativaHSacne inversaAVTX-009LY2189102FL-101
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.