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AVTX-009 Regimen 1

Phase 2

Hidradenitis Suppurativa | Small molecule | Dermatology |Avalo Therapeutics, Inc.|Last Updated: Apr 21, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment253

FDA Designations

No designations recorded

Clinical trial landscape

AVTX-009 Regimen 1 · 1 trial · 1 indication

Phase 2 1
NCT06603077A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis SuppurativaHidradenitis Suppurativa
COMPLETED253 Analytics
PHASE2COMPLETED
A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis SuppurativaUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
At Week 16

HiSCR75 is defined as at least a 75% reduction in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count, relative to Baseline.

Secondary Endpoints

Proportion of patients achieving HiSCR50
At Week 16
Proportion of patients achieving HiSCR90
At Week 16
Change from Baseline in International HS Severity Score System (IHS4)
Baseline (Day 1) and Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AVTX-009 Regimen 1EXPERIMENTALPatients will receive AVTX-009 regimen 1.
AVTX-009 Regimen 2EXPERIMENTALPatients will receive AVTX-009 regimen 2.
PlaceboPLACEBO_COMPARATORPatients will receive matching placebo.

Interventions

NameTypeDescription
AVTX-009 Regimen 1DRUGAVTX-009 will be administered as a subcutaneous injection every 4 weeks.
AVTX-009 Regimen 2DRUGAVTX-009 will be administered as a subcutaneous injection every 2 weeks.
PlaceboDRUGMatching placebo will be administered as a subcutaneous injection every 2 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites89

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....

Countries:United StatesAustraliaBulgariaCanadaCzechiaFranceGermanyGreeceItalyPolandSlovakiaSpainTurkey (Türkiye)
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