CompletedPhase 2

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

United States253 participantsStarted 2024-09-16

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

Timeframe: At Week 16

Trial details

NCT IDNCT06603077

SponsorAvalo Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-23

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