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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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).

Key facts

Study ID

NCT06603077

Run by

Avalo Therapeutics, Inc.

People needed

253

Starts

2024-09-16

Expected to finish

2026-03-17

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Has a draining fistula count of ≥ 20.
• 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.

Where it is running

• Clinical Site 1037 — Scottsdale, Arizona, United States
• Clinical Site 1026 — Tucson, Arizona, United States
• Clinical Site 1032 — Northridge, California, United States
• Clinical Site 1019 — Pomona, California, United States
• Clinical Site 1009 — Sacramento, California, United States
• Clinical Site 1034 — Santa Monica, California, United States
• Clinical Site 1011 — Washington D.C., District of Columbia, United States
• Clinical Site 1029 — Boca Raton, Florida, United States
• Clinical Site 1002 — Coral Gables, Florida, United States
• Clinical Site 1015 — Maitland, Florida, United States
• Clinical Site 1027 — North Miami Beach, Florida, United States
• Clinical Site 1013 — Tampa, Florida, United States
• Clinical Site 1008 — Savannah, Georgia, United States
• Clinical Site 1014 — Chicago, Illinois, United States
• Clinical Site 1028 — West Lafayette, Indiana, United States
• Clinical Site 1031 — Bowling Green, Kentucky, United States
• Clinical Site 1024 — Murray, Kentucky, United States
• Clinical Site 1042 — Boston, Massachusetts, United States
• Clinical Site 1001 — Boston, Massachusetts, United States
• Clinical Site 1030 — Detroit, Michigan, United States
• Clinical Site 1007 — Fort Gratiot, Michigan, United States
• Clinical Site 1041 — Oakland, Michigan, United States
• Clinical Site 1003 — Portsmouth, New Hampshire, United States
• Clinical Site 1036 — Brooklyn, New York, United States
• Clinical Site 1022 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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