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

Last updated: March 24, 2026
Sponsor: Avalo Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Hidradenitis Suppurativa

Rosacea

Acne Inversa

Treatment

AVTX-009 Regimen 2

AVTX-009 Regimen 1

Placebo

Clinical Study ID

NCT06603077
AVTX-009-HS-201
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signs and symptoms of hidradenitis suppurativa (HS) for at least 6 months prior toScreening.

  2. At least 5 inflammatory lesions in at least 2 distinct anatomical areas, at least 1of which is Hurley Stage 2 or 3.

Exclusion

Exclusion Criteria:

  1. Has a draining fistula count of ≥ 20.

  2. Has another active skin inflammatory condition, infection (viral, bacterial, orfungal), or another active ongoing inflammatory disease (other than HS) thatrequires treatment with a prohibited medication, which could interfere with theassessment of HS.

  3. History of chronic or recurrent infectious disease, including but not limited tochronic 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.

Study Design

Total Participants: 250
Treatment Group(s): 3
Primary Treatment: AVTX-009 Regimen 2
Phase: 2
Study Start date:
September 16, 2024
Estimated Completion Date:
April 30, 2026

Study 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 will comprise:

  1. A Screening Period which will last up to 28 days.

  2. A Treatment Period up to 16 weeks.

  3. A Follow-up period of 6 weeks after the last dose of study drug.

The maximum clinical trial duration for each participant is 24 weeks.

Connect with a study center

  • Clinical Site 1203

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Clinical Site 1201

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Clinical Site 1203

    Darlinghurst 2169378, New South Wales 2155400 2010
    Australia

    Site Not Available

  • Clinical Site 1201

    Westmead 2143973, New South Wales 2155400 2145
    Australia

    Site Not Available

  • Clinical Site 1204

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Clinical Site 1204

    Woolloongabba 6943568, Queensland 2152274 4102
    Australia

    Site Not Available

  • Clinical Site 1202

    Carlton, Victoria 3053
    Australia

    Site Not Available

  • Clinical Site 1202

    Carlton 2172293, Victoria 2145234 3053
    Australia

    Site Not Available

  • Clinical Site 1303

    Sofia, Sofia-Grad 1463
    Bulgaria

    Site Not Available

  • Clinical Site 1303

    Sofia 727011, Sofia-Grad 731061 1463
    Bulgaria

    Site Not Available

  • Clinical Site 1302

    Lovech, 5500
    Bulgaria

    Site Not Available

  • Clinical Site 1302

    Lovech 729559, 5500
    Bulgaria

    Site Not Available

  • Clinical Site 1301

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Clinical Site 1301

    Pleven 728203, 5800
    Bulgaria

    Site Not Available

  • Clinical Site 1304

    Stara Zagora, 6003
    Bulgaria

    Site Not Available

  • Clinical Site 1304

    Stara Zagora 726848, 6003
    Bulgaria

    Site Not Available

  • Clinical Site 1105

    Edmonton, Alberta T5K 1X3
    Canada

    Site Not Available

  • Clinical Site 1108

    Edmonton, Alberta T6W 4V4
    Canada

    Site Not Available

  • Clinical Site 1105

    Edmonton 5946768, Alberta 5883102 T5K 1X3
    Canada

    Site Not Available

  • Clinical Site 1108

    Edmonton 5946768, Alberta 5883102 T6W 4V4
    Canada

    Site Not Available

  • Clinical Site 1103

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Clinical Site 1104

    Hamilton, Ontario L8L 3C3
    Canada

    Site Not Available

  • Clinical Site 1107

    London, Ontario N6A 2C2
    Canada

    Site Not Available

  • Clinical Site 1106

    Toronto, Ontario M2N 3A6
    Canada

    Site Not Available

  • Clinical Site 1103

    Barrie 5894171, Ontario 6093943 L4M 7G1
    Canada

    Site Not Available

  • Clinical Site 1104

    Hamilton 5969782, Ontario 6093943 L8L 3C3
    Canada

    Site Not Available

  • Clinical Site 1107

    London 6058560, Ontario 6093943 N6A 2C2
    Canada

    Site Not Available

  • Clinical Site 1106

    Toronto 6167865, Ontario 6093943 M2N 3A6
    Canada

    Site Not Available

  • Clinical Site 1110

    Montreal, Quebec H1Y 3L1
    Canada

    Site Not Available

  • Clinical Site 1110

    Montreal 6077243, Quebec 6115047 H1Y 3L1
    Canada

    Site Not Available

  • Clinical Site 1101

    Saskatoon, Saskatchewan S7K 2C1
    Canada

    Site Not Available

  • Clinical Site 1101

    Saskatoon 6141256, Saskatchewan 6141242 S7K 2C1
    Canada

    Site Not Available

  • Clinical Site 1111

    Québec, G1W 4R4
    Canada

    Site Not Available

  • Clinical Site 1111

    Québec 6325494, G1W 4R4
    Canada

    Site Not Available

  • Clinical Site 1401

    Praha 10, Prague 100 34
    Czech Republic

    Active - Recruiting

  • Clinical Site 1402

    Praha 5, Prague 150 06
    Czech Republic

    Active - Recruiting

  • Clinical Site 1401

    Prague, Prague 100 34
    Czechia

    Site Not Available

  • Clinical Site 1402

    Prague, Prague 150 06
    Czechia

    Site Not Available

  • Clinical Site 1401

    Praha 10, Prague 100 34
    Czechia

    Site Not Available

  • Clinical Site 1402

    Praha 5, Prague 150 06
    Czechia

    Site Not Available

  • Clinical Site 1401

    Prague 3067696, Prague 3067695 100 34
    Czechia

    Site Not Available

  • Clinical Site 1402

    Prague 3067696, Prague 3067695 150 06
    Czechia

    Site Not Available

  • Clinical Site 1503

    Antony, Hauts-de-Seine 92160
    France

    Site Not Available

  • Clinical Site 1503

    Antony 3037423, Hauts-de-Seine 92160
    France

    Site Not Available

  • Clinical Site 1505

    Amiens, Picardie 80054
    France

    Site Not Available

  • Clinical Site 1505

    Amiens 3037854, Picardie 80054
    France

    Site Not Available

  • Clinical Site 1502

    Lyon, Rhône 69003
    France

    Site Not Available

  • Clinical Site 1502

    Lyon 2996944, Rhône 69003
    France

    Site Not Available

  • Clinical Site 1501

    Rouen, Seine-Maritime 76031
    France

    Site Not Available

  • Clinical Site 1501

    Rouen 2982652, Seine-Maritime 76031
    France

    Site Not Available

  • Clinical Site 1501

    Rouen Cedex, Seine-Maritime 76031
    France

    Site Not Available

  • Clinical Site 1504

    Paris, Île-de-France Region 75010
    France

    Site Not Available

  • Clinical Site 1504

    Paris 2988507, Île-de-France Region 3012874 75010
    France

    Site Not Available

  • Clinical Site 1606

    Erlangen, Bavaria 91054
    Germany

    Site Not Available

  • Clinical Site 1606

    Erlangen 2929567, Bavaria 2951839 91054
    Germany

    Site Not Available

  • Clinical Site 1604

    Frankfurt am Main, Hesse 60590
    Germany

    Site Not Available

  • Clinical Site 1604

    Frankfurt am Main 2925533, Hesse 2905330 60590
    Germany

    Site Not Available

  • Clinical Site 1604

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Clinical Site 1602

    Muenster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Clinical Site 1601

    Bochum, North Rhine-Westphalia 44791
    Germany

    Site Not Available

  • Clinical Site 1602

    Münster, North Rhine-Westphalia 48149
    Germany

    Site Not Available

  • Clinical Site 1601

    Bochum 2947416, North Rhine-Westphalia 2861876 44791
    Germany

    Site Not Available

  • Clinical Site 1602

    Münster 2867543, North Rhine-Westphalia 2861876 48149
    Germany

    Site Not Available

  • Clinical Site 1605

    Dresden, Saxony 01307
    Germany

    Site Not Available

  • Clinical Site 1605

    Dresden 2935022, Saxony 2842566 01307
    Germany

    Site Not Available

  • Clinical Site 2101

    Athens, Attica 16121
    Greece

    Site Not Available

  • Clinical Site 2103

    Athens, Attica 124 62
    Greece

    Site Not Available

  • Clinical Site 2101

    Athens 264371, Attica 6692632 16121
    Greece

    Site Not Available

  • Clinical Site 2103

    Athens 264371, Attica 6692632 124 62
    Greece

    Site Not Available

  • Clinical Site 2102

    Efkarpia, Thessaloniki 56429
    Greece

    Site Not Available

  • Clinical Site 2102

    Efkarpia 736296, Thessaloniki 56429
    Greece

    Site Not Available

  • Clinical Site 1901

    Torrette, Ancona 60126
    Italy

    Site Not Available

  • Clinical Site 1901

    Torrette 8960841, Ancona 60126
    Italy

    Site Not Available

  • Clinical Site 1903

    Rozzano, Milano 20089
    Italy

    Site Not Available

  • Clinical Site 1903

    Rozzano 3168837, Milano 20089
    Italy

    Site Not Available

  • Clinical Site 1902

    Ferrara, 44124
    Italy

    Site Not Available

  • Clinical Site 1902

    Ferrara 3177090, 44124
    Italy

    Site Not Available

  • Clinical Site 1908

    Milan, 20122
    Italy

    Site Not Available

  • Clinical Site 1908

    Milan 6951411, 20122
    Italy

    Site Not Available

  • Clinical Site 1908

    Milano, 20122
    Italy

    Site Not Available

  • Clinical Site 1906

    Pisa, 56126
    Italy

    Site Not Available

  • Clinical Site 1906

    Pisa 3170647, 56126
    Italy

    Site Not Available

  • Clinical Site 1904

    Roma, 168
    Italy

    Site Not Available

  • Clinical Site 1907

    Roma, 00144
    Italy

    Site Not Available

  • Clinical Site 1904

    Roma 8957247, 168
    Italy

    Site Not Available

  • Clinical Site 1907

    Roma 8957247, 00144
    Italy

    Site Not Available

  • Clinical Site 1702

    Wroclaw, Kuyavian-Pomeranian Voivodeship 51-685
    Poland

    Site Not Available

  • Clinical Site 1706

    Wroclaw, Lower Silesian Voivodeship 50-566
    Poland

    Site Not Available

  • Clinical Site 1706

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 50-566
    Poland

    Site Not Available

  • Clinical Site 1703

    Bialystok, Podlaskie Voivodeship 15-453
    Poland

    Site Not Available

  • Clinical Site 1703

    Bialystok 776069, Podlaskie Voivodeship 858789 15-453
    Poland

    Site Not Available

  • Clinical Site 1701

    Warszawa, Pomeranian Voivodeship 02-507
    Poland

    Site Not Available

  • Clinical Site 1705

    Warszawa, Pomeranian Voivodeship 02-962
    Poland

    Site Not Available

  • Clinical Site 1704

    Ossy, Silesian Voivodeship 42-624
    Poland

    Site Not Available

  • Clinical Site 1704

    Ossy 3089794, Silesian Voivodeship 3337497 42-624
    Poland

    Site Not Available

  • Clinical Site 2202

    Svidník, Presov 089 01
    Slovakia

    Site Not Available

  • Clinical Site 2202

    Svidník 723417, Presov 865085 089 01
    Slovakia

    Site Not Available

  • Clinical Site 2202

    Svidnik, Presovsky Kraj 089 01
    Slovakia

    Site Not Available

  • Clinical Site 2201

    Trnava, Trnava Region 917 75
    Slovakia

    Site Not Available

  • Clinical Site 2201

    Trnava 3057124, Trnava Region 3343958 917 75
    Slovakia

    Site Not Available

  • Clinical Site 1801

    Manises, Valencia 46940
    Spain

    Site Not Available

  • Clinical Site 1801

    Manises 2514197, Valencia 2593113 46940
    Spain

    Site Not Available

  • Clinical Site 1802

    Granada, 18012
    Spain

    Site Not Available

  • Clinical Site 1802

    Granada 2517117, 18012
    Spain

    Site Not Available

  • Clinical Site 1803

    Madrid, 28034
    Spain

    Site Not Available

  • Clinical Site 1803

    Madrid 3117735, 28034
    Spain

    Site Not Available

  • Clinical Site 1804

    Sevilla, 41009
    Spain

    Site Not Available

  • Clinical Site 1804

    Seville, 41009
    Spain

    Site Not Available

  • Clinical Site 1804

    Seville 2510911, 41009
    Spain

    Site Not Available

  • Clinical Site 2001

    Gaziantep, 27310
    Turkey

    Site Not Available

  • Clinical Site 2001

    Gaziantep, 27310
    Turkey (Türkiye)

    Site Not Available

  • Clinical Site 2001

    Gaziantep 314830, 27310
    Turkey (Türkiye)

    Site Not Available

  • Clinical Site 2002

    Samsun, 55270
    Turkey (Türkiye)

    Site Not Available

  • Clinical Site 2002

    Samsun 740264, 55270
    Turkey (Türkiye)

    Site Not Available

  • Clinical Site 1022

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Clinical Site 1037

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Clinical Site 1026

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Clinical Site 1022

    Scottsdale 5313457, Arizona 5551752 85260
    United States

    Site Not Available

  • Clinical Site 1037

    Scottsdale 5313457, Arizona 5551752 85260
    United States

    Site Not Available

  • Clinical Site 1026

    Tucson 5318313, Arizona 5551752 85704
    United States

    Site Not Available

  • Clinical Site 1032

    Northridge, California 91325
    United States

    Site Not Available

  • Clinical Site 1019

    Pomona, California 91767
    United States

    Site Not Available

  • Clinical Site 1009

    Sacramento, California 95815
    United States

    Site Not Available

  • Clinical Site 1034

    Santa Monica, California 90024
    United States

    Site Not Available

  • Clinical Site 1032

    Northridge 5377985, California 5332921 91325
    United States

    Site Not Available

  • Clinical Site 1019

    Pomona 5384170, California 5332921 91767
    United States

    Site Not Available

  • Clinical Site 1009

    Sacramento 5389489, California 5332921 95815
    United States

    Site Not Available

  • Clinical Site 1034

    Santa Monica 5393212, California 5332921 90024
    United States

    Site Not Available

  • Clinical Site 1011

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Clinical Site 1011

    Washington D.C., District of Columbia 20010
    United States

    Site Not Available

  • Clinical Site 1011

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Site Not Available

  • Clinical Site 1029

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Clinical Site 1002

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Clinical Site 1015

    Maitland, Florida 32751
    United States

    Site Not Available

  • Clinical Site 1027

    North Miami Beach, Florida 33162-4708
    United States

    Site Not Available

  • Clinical Site 1013

    Tampa, Florida 33613
    United States

    Site Not Available

  • Clinical Site 1029

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Site Not Available

  • Clinical Site 1002

    Coral Gables 4151871, Florida 4155751 33134
    United States

    Site Not Available

  • Clinical Site 1015

    Maitland 4163220, Florida 4155751 32751
    United States

    Site Not Available

  • Clinical Site 1027

    North Miami Beach 4166233, Florida 4155751 33162-4708
    United States

    Site Not Available

  • Clinical Site 1013

    Tampa 4174757, Florida 4155751 33613
    United States

    Site Not Available

  • Clinical Site

    Savannah, Georgia 31419
    United States

    Active - Recruiting

  • Clinical Site 1008

    Savannah, Georgia 31419
    United States

    Site Not Available

  • Clinical Site 1008

    Savannah 4221552, Georgia 4197000 31419
    United States

    Site Not Available

  • Clinical Site 1014

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Clinical Site 1014

    Chicago 4887398, Illinois 4896861 60640
    United States

    Site Not Available

  • Clinical Site 1028

    West Lafayette, Indiana 47906
    United States

    Site Not Available

  • Clinical Site 1028

    West Lafayette 4928096, Indiana 4921868 47906
    United States

    Site Not Available

  • Clinical Site 1031

    Bowling Green, Kentucky 42104
    United States

    Site Not Available

  • Clinical Site 1024

    Murray, Kentucky 42071
    United States

    Site Not Available

  • Clinical Site 1031

    Bowling Green 4285268, Kentucky 6254925 42104
    United States

    Site Not Available

  • Clinical Site 1024

    Murray 4302035, Kentucky 6254925 42071
    United States

    Site Not Available

  • Clinical Site 1001

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Clinical Site 1042

    Boston, Massachusetts 02115-5804
    United States

    Site Not Available

  • Clinical Site 1001

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Clinical Site 1042

    Boston 4930956, Massachusetts 6254926 02115-5804
    United States

    Site Not Available

  • Clinical Site 1030

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Clinical Site 1007

    Fort Gratiot, Michigan 48059
    United States

    Site Not Available

  • Clinical Site

    Ft. Gratiot, Michigan 48059
    United States

    Active - Recruiting

  • Clinical Site 1007

    Ft. Gratiot, Michigan 48059
    United States

    Site Not Available

  • Clinical Site 1041

    Oakland, Michigan 48328
    United States

    Site Not Available

  • Clinical Site 1030

    Detroit 4990729, Michigan 5001836 48201
    United States

    Site Not Available

  • Clinical Site 1041

    Oakland 7120431, Michigan 5001836 48328
    United States

    Site Not Available

  • Clinical Site 1003

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Clinical Site 1003

    Portsmouth 5091383, New Hampshire 5090174 03801
    United States

    Site Not Available

  • Clinical Site 1023

    Bronx, New York 10467
    United States

    Site Not Available

  • Clinical Site 1036

    Brooklyn, New York 10023
    United States

    Site Not Available

  • Clinical Site 1016

    New York, New York 10003
    United States

    Site Not Available

  • Clinical Site 1023

    The Bronx, New York 10467
    United States

    Site Not Available

  • Clinical Site 1036

    Brooklyn 5110302, New York 5128638 10023
    United States

    Site Not Available

  • Clinical Site 1016

    New York 5128581, New York 5128638 10003
    United States

    Site Not Available

  • Clinical Site 1023

    The Bronx 5110266, New York 5128638 10467
    United States

    Site Not Available

  • Clinical Site 1020

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Clinical Site 1010

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Clinical Site 1017

    Dublin, Ohio 43016
    United States

    Site Not Available

  • Clinical Site 1020

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • Clinical Site 1010

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • Clinical Site 1017

    Dublin 5152333, Ohio 5165418 43016
    United States

    Site Not Available

  • Clinical Site 1004

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

  • Clinical Site 1035

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Clinical Site 1004

    Philadelphia 4560349, Pennsylvania 6254927 19103
    United States

    Site Not Available

  • Clinical Site 1035

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • Clinical Site 1018

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • Clinical Site 1025

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Clinical Site 1018

    Johnston 8604682, Rhode Island 5224323 02919
    United States

    Site Not Available

  • Clinical Site 1025

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Site Not Available

  • Clinical Site

    Greenville, South Carolina 29615
    United States

    Active - Recruiting

  • Clinical Site 1005

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Clinical Site 1005

    Greenville 4580543, South Carolina 4597040 29615
    United States

    Site Not Available

  • Clinical Site 1012

    Arlington, Texas 76011
    United States

    Site Not Available

  • Clinical Site 1012

    Arlington 4671240, Texas 4736286 76011
    United States

    Site Not Available

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