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

NCT06603077 | Completed Phase 2 FDA Drug

• 1 other identifier: AVTX-009-HS-201
• Study Type: interventional
• Target: 253
• Locations: 13 countries
• Sites: 89

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).

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa; HS; acne inversa; AVTX-009; LY2189102; FL-101

Outcome Measures

Primary Outcomes (1)

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

  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.

  At Week 16

Secondary Outcomes (9)

• 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

• Change from Baseline in total abscess and inflammatory nodule (AN) count

  Baseline (Day 1) and Week 16

• Change from Baseline in draining fistula count

  Baseline (Day 1) and Week 16

Study Arms (3)

AVTX-009 Regimen 1

EXPERIMENTAL

Patients will receive AVTX-009 regimen 1.

Drug: AVTX-009 Regimen 1

AVTX-009 Regimen 2

EXPERIMENTAL

Patients will receive AVTX-009 regimen 2.

Drug: AVTX-009 Regimen 2

Placebo

PLACEBO COMPARATOR

Patients will receive matching placebo.

Drug: Placebo

Interventions

AVTX-009 Regimen 1 DRUG

AVTX-009 will be administered as a subcutaneous injection every 4 weeks.

AVTX-009 Regimen 1

AVTX-009 Regimen 2 DRUG

AVTX-009 will be administered as a subcutaneous injection every 2 weeks.

AVTX-009 Regimen 2

Placebo DRUG

Matching placebo will be administered as a subcutaneous injection every 2 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avalo Therapeutics, Inc.: lead

Study Sites (89)

Clinical Site 1022

Scottsdale, Arizona, 85260, United States

Location

Clinical Site 1037

Scottsdale, Arizona, 85260, United States

Location

Clinical Site 1026

Tucson, Arizona, 85704, United States

Location

Clinical Site 1032

Northridge, California, 91325, United States

Location

Clinical Site 1019

Pomona, California, 91767, United States

Location

Clinical Site 1009

Sacramento, California, 95815, United States

Location

Clinical Site 1034

Santa Monica, California, 90024, United States

Location

Clinical Site 1011

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

Location

Clinical Site 1029

Boca Raton, Florida, 33486, United States

Location

Clinical Site 1002

Coral Gables, Florida, 33134, United States

Location

Clinical Site 1015

Maitland, Florida, 32751, United States

Location

Clinical Site 1027

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

Location

Clinical Site 1013

Tampa, Florida, 33613, United States

Location

Clinical Site 1008

Savannah, Georgia, 31419, United States

Location

Clinical Site 1014

Chicago, Illinois, 60640, United States

Location

Clinical Site 1028

West Lafayette, Indiana, 47906, United States

Location

Clinical Site 1031

Bowling Green, Kentucky, 42104, United States

Location

Clinical Site 1024

Murray, Kentucky, 42071, United States

Location

Clinical Site 1042

Boston, Massachusetts, 02115-5804, United States

Location

Clinical Site 1001

Boston, Massachusetts, 02215, United States

Location

Clinical Site 1030

Detroit, Michigan, 48201, United States

Location

Clinical Site 1007

Fort Gratiot, Michigan, 48059, United States

Location

Clinical Site 1041

Oakland, Michigan, 48328, United States

Location

Clinical Site 1003

Portsmouth, New Hampshire, 03801, United States

Location

Clinical Site 1036

Brooklyn, New York, 10023, United States

Location

Clinical Site 1016

New York, New York, 10003, United States

Location

Clinical Site 1023

The Bronx, New York, 10467, United States

Location

Clinical Site 1020

Cincinnati, Ohio, 45219, United States

Location

Clinical Site 1010

Cleveland, Ohio, 44106, United States

Location

Clinical Site 1017

Dublin, Ohio, 43016, United States

Location

Clinical Site 1004

Philadelphia, Pennsylvania, 19103, United States

Location

Clinical Site 1035

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical Site 1018

Johnston, Rhode Island, 02919, United States

Location

Clinical Site 1025

Providence, Rhode Island, 02903, United States

Location

Clinical Site 1005

Greenville, South Carolina, 29615, United States

Location

Clinical Site 1012

Arlington, Texas, 76011, United States

Location

Clinical Site 1203

Darlinghurst, New South Wales, 2010, Australia

Location

Clinical Site 1201

Westmead, New South Wales, 2145, Australia

Location

Clinical Site 1204

Woolloongabba, Queensland, 4102, Australia

Location

Clinical Site 1202

Carlton, Victoria, 3053, Australia

Location

Clinical Site 1303

Sofia, Sofia-Grad, 1463, Bulgaria

Location

Clinical Site 1302

Lovech, 5500, Bulgaria

Location

Clinical Site 1301

Pleven, 5800, Bulgaria

Location

Clinical Site 1304

Stara Zagora, 6003, Bulgaria

Location

Clinical Site 1105

Edmonton, Alberta, T5K 1X3, Canada

Location

Clinical Site 1108

Edmonton, Alberta, T6W 4V4, Canada

Location

Clinical Site 1103

Barrie, Ontario, L4M 7G1, Canada

Location

Clinical Site 1104

Hamilton, Ontario, L8L 3C3, Canada

Location

Clinical Site 1107

London, Ontario, N6A 2C2, Canada

Location

Clinical Site 1106

Toronto, Ontario, M2N 3A6, Canada

Location

Clinical Site 1110

Montreal, Quebec, H1Y 3L1, Canada

Location

Clinical Site 1101

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

Clinical Site 1111

Québec, G1W 4R4, Canada

Location

Clinical Site 1401

Prague, Prague, 100 34, Czechia

Location

Clinical Site 1402

Prague, Prague, 150 06, Czechia

Location

Clinical Site 1503

Antony, Hauts-de-Seine, 92160, France

Location

Clinical Site 1505

Amiens, Picardie, 80054, France

Location

Clinical Site 1502

Lyon, Rhône, 69003, France

Location

Clinical Site 1501

Rouen, Seine-Maritime, 76031, France

Location

Clinical Site 1504

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

Location

Clinical Site 1606

Erlangen, Bavaria, 91054, Germany

Location

Clinical Site 1604

Frankfurt am Main, Hesse, 60590, Germany

Location

Clinical Site 1601

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Clinical Site 1602

Münster, North Rhine-Westphalia, 48149, Germany

Location

Clinical Site 1605

Dresden, Saxony, 01307, Germany

Location

Clinical Site 2103

Athens, Attica, 124 62, Greece

Location

Clinical Site 2101

Athens, Attica, 16121, Greece

Location

Clinical Site 2102

Efkarpia, Thessaloniki, 56429, Greece

Location

Clinical Site 1901

Torrette, Ancona, 60126, Italy

Location

Clinical Site 1903

Rozzano, Milano, 20089, Italy

Location

Clinical Site 1902

Ferrara, 44124, Italy

Location

Clinical Site 1908

Milan, 20122, Italy

Location

Clinical Site 1906

Pisa, 56126, Italy

Location

Clinical Site 1907

Roma, 00144, Italy

Location

Clinical Site 1904

Roma, 168, Italy

Location

Clinical Site 1702

Wroclaw, Kuyavian-Pomeranian Voivodeship, 51-685, Poland

Location

Clinical Site 1706

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

Location

Clinical Site 1703

Bialystok, Podlaskie Voivodeship, 15-453, Poland

Location

Clinical Site 1701

Warszawa, Pomeranian Voivodeship, 02-507, Poland

Location

Clinical Site 1705

Warszawa, Pomeranian Voivodeship, 02-962, Poland

Location

Clinical Site 1704

Ossy, Silesian Voivodeship, 42-624, Poland

Location

Clinical Site 2202

Svidník, Presov, 089 01, Slovakia

Location

Clinical Site 2201

Trnava, Trnava Region, 917 75, Slovakia

Location

Clinical Site 1801

Manises, Valencia, 46940, Spain

Location

Clinical Site 1802

Granada, 18012, Spain

Location

Clinical Site 1803

Madrid, 28034, Spain

Location

Clinical Site 1804

Seville, 41009, Spain

Location

Clinical Site 2001

Gaziantep, 27310, Turkey (Türkiye)

Location

Clinical Site 2002

Samsun, 55270, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: September 16, 2024
• Primary Completion: February 23, 2026
• Study Completion: March 17, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (36); BU (4); ES (4); TU (2); FR (5); DE (5); GR (3); IT (7); PL (6); SL (2); CA (9); CZ (2); AU (4)