A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT06603077
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
250 participants
INTERVENTIONAL
2024-09-16
2026-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AVTX-009 Regimen 1
Patients will receive AVTX-009 regimen 1.
AVTX-009 Regimen 1
AVTX-009 will be administered as a subcutaneous injection every 4 weeks.
AVTX-009 Regimen 2
Patients will receive AVTX-009 regimen 2.
AVTX-009 Regimen 2
AVTX-009 will be administered as a subcutaneous injection every 2 weeks.
Placebo
Patients will receive matching placebo.
Placebo
Matching placebo will be administered as a subcutaneous injection every 2 weeks.
Interventions
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AVTX-009 Regimen 1
AVTX-009 will be administered as a subcutaneous injection every 4 weeks.
AVTX-009 Regimen 2
AVTX-009 will be administered as a subcutaneous injection every 2 weeks.
Placebo
Matching placebo will be administered as a subcutaneous injection every 2 weeks.
Eligibility Criteria
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Inclusion Criteria
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
2. 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.
3. 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).
4. Has severe, progressive and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or immunosuppressive disease.
18 Years
ALL
No
Sponsors
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Avalo Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Site 1022
Scottsdale, Arizona, United States
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 1016
New York, New York, United States
Clinical Site 1023
The Bronx, New York, United States
Clinical Site 1020
Cincinnati, Ohio, United States
Clinical Site 1010
Cleveland, Ohio, United States
Clinical Site 1017
Dublin, Ohio, United States
Clinical Site 1004
Philadelphia, Pennsylvania, United States
Clinical Site 1035
Pittsburgh, Pennsylvania, United States
Clinical Site 1018
Johnston, Rhode Island, United States
Clinical Site 1025
Providence, Rhode Island, United States
Clinical Site 1005
Greenville, South Carolina, United States
Clinical Site 1012
Arlington, Texas, United States
Clinical Site 1203
Darlinghurst, New South Wales, Australia
Clinical Site 1201
Westmead, New South Wales, Australia
Clinical Site 1204
Woolloongabba, Queensland, Australia
Clinical Site 1202
Carlton, Victoria, Australia
Clinical Site 1303
Sofia, Sofia-Grad, Bulgaria
Clinical Site 1302
Lovech, , Bulgaria
Clinical Site 1301
Pleven, , Bulgaria
Clinical Site 1304
Stara Zagora, , Bulgaria
Clinical Site 1105
Edmonton, Alberta, Canada
Clinical Site 1108
Edmonton, Alberta, Canada
Clinical Site 1103
Barrie, Ontario, Canada
Clinical Site 1104
Hamilton, Ontario, Canada
Clinical Site 1107
London, Ontario, Canada
Clinical Site 1106
Toronto, Ontario, Canada
Clinical Site 1110
Montreal, Quebec, Canada
Clinical Site 1101
Saskatoon, Saskatchewan, Canada
Clinical Site 1111
Québec, , Canada
Clinical Site 1401
Prague, Prague, Czechia
Clinical Site 1402
Prague, Prague, Czechia
Clinical Site 1503
Antony, Hauts-de-Seine, France
Clinical Site 1505
Amiens, Picardie, France
Clinical Site 1502
Lyon, Rhône, France
Clinical Site 1501
Rouen, Seine-Maritime, France
Clinical Site 1504
Paris, Île-de-France Region, France
Clinical Site 1606
Erlangen, Bavaria, Germany
Clinical Site 1604
Frankfurt am Main, Hesse, Germany
Clinical Site 1601
Bochum, North Rhine-Westphalia, Germany
Clinical Site 1602
Münster, North Rhine-Westphalia, Germany
Clinical Site 1605
Dresden, Saxony, Germany
Clinical Site 2103
Athens, Attica, Greece
Clinical Site 2101
Athens, Attica, Greece
Clinical Site 2102
Efkarpia, Thessaloniki, Greece
Clinical Site 1901
Torrette, Ancona, Italy
Clinical Site 1903
Rozzano, Milano, Italy
Clinical Site 1902
Ferrara, , Italy
Clinical Site 1908
Milan, , Italy
Clinical Site 1906
Pisa, , Italy
Clinical Site 1907
Roma, , Italy
Clinical Site 1904
Roma, , Italy
Clinical Site 1702
Wroclaw, Kuyavian-Pomeranian Voivodeship, Poland
Clinical Site 1706
Wroclaw, Lower Silesian Voivodeship, Poland
Clinical Site 1703
Bialystok, Podlaskie Voivodeship, Poland
Clinical Site 1701
Warszawa, Pomeranian Voivodeship, Poland
Clinical Site 1705
Warszawa, Pomeranian Voivodeship, Poland
Clinical Site 1704
Ossy, Silesian Voivodeship, Poland
Clinical Site 2202
Svidník, Presov, Slovakia
Clinical Site 2201
Trnava, Trnava Region, Slovakia
Clinical Site 1801
Manises, Valencia, Spain
Clinical Site 1802
Granada, , Spain
Clinical Site 1803
Madrid, , Spain
Clinical Site 1804
Seville, , Spain
Clinical Site 2001
Gaziantep, , Turkey (Türkiye)
Clinical Site 2002
Samsun, , Turkey (Türkiye)
Countries
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Other Identifiers
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AVTX-009-HS-201
Identifier Type: -
Identifier Source: org_study_id