Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa
Lead Sponsor:
Avalo Therapeutics, Inc.
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study. Patients will be randomized to one of two AVTX-009 dose regimens or matching placebo in a 1:1:1 ratio. The study...
Eligibility Criteria
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 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.
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06603077
Start Date
September 16 2024
End Date
April 1 2026
Last Update
November 13 2025
Active Locations (89)
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1
Clinical Site 1022
Scottsdale, Arizona, United States, 85260
2
Clinical Site 1037
Scottsdale, Arizona, United States, 85260
3
Clinical Site 1026
Tucson, Arizona, United States, 85704
4
Clinical Site 1032
Northridge, California, United States, 91325