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

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa (LOTUS)

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).

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: AVTX-009 Regimen 1; Drug: AVTX-009 Regimen 2; Drug: Placebo

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 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.

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Clinical Site 1203
    • Westmead, New South Wales, Australia, 2145
      • Clinical Site 1201
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Clinical Site 1204
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Clinical Site 1202
• Bulgaria
  • Lovech, Bulgaria, 5500
    • Clinical Site 1302
  • Pleven, Bulgaria, 5800
    • Clinical Site 1301
  • Stara Zagora, Bulgaria, 6003
    • Clinical Site 1304
  • Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1463
      • Clinical Site 1303
• Canada
  • Québec, Canada, G1W 4R4
    • Clinical Site 1111
  • Alberta
    • Edmonton, Alberta, Canada, T5K 1X3
      • Clinical Site 1105
    • Edmonton, Alberta, Canada, T6W 4V4
      • Clinical Site 1108
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Clinical Site 1103
    • Hamilton, Ontario, Canada, L8L 3C3
      • Clinical Site 1104
    • London, Ontario, Canada, N6A 2C2
      • Clinical Site 1107
    • Toronto, Ontario, Canada, M2N 3A6
      • Clinical Site 1106
  • Quebec
    • Montreal, Quebec, Canada, H1Y 3L1
      • Clinical Site 1110
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 2C1
      • Clinical Site 1101
• Czechia
  • Prague
    • Prague, Prague, Czechia, 100 34
      • Clinical Site 1401
    • Prague, Prague, Czechia, 150 06
      • Clinical Site 1402
• France
  • Hauts-de-Seine
    • Antony, Hauts-de-Seine, France, 92160
      • Clinical Site 1503
  • Picardie
    • Amiens, Picardie, France, 80054
      • Clinical Site 1505
  • Rhône
    • Lyon, Rhône, France, 69003
      • Clinical Site 1502
  • Seine-Maritime
    • Rouen, Seine-Maritime, France, 76031
      • Clinical Site 1501
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75010
      • Clinical Site 1504
• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Clinical Site 1606
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Clinical Site 1604
  • North Rhine-Westphalia
    • Bochum, North Rhine-Westphalia, Germany, 44791
      • Clinical Site 1601
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Clinical Site 1602
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Clinical Site 1605
• Greece
  • Attica
    • Athens, Attica, Greece, 124 62
      • Clinical Site 2103
    • Athens, Attica, Greece, 16121
      • Clinical Site 2101
  • Thessaloniki
    • Efkarpia, Thessaloniki, Greece, 56429
      • Clinical Site 2102
• Italy
  • Ferrara, Italy, 44124
    • Clinical Site 1902
  • Milan, Italy, 20122
    • Clinical Site 1908
  • Pisa, Italy, 56126
    • Clinical Site 1906
  • Roma, Italy, 00144
    • Clinical Site 1907
  • Roma, Italy, 168
    • Clinical Site 1904
  • Ancona
    • Torrette, Ancona, Italy, 60126
      • Clinical Site 1901
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Clinical Site 1903
• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Wroclaw, Kuyavian-Pomeranian Voivodeship, Poland, 51-685
      • Clinical Site 1702
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
      • Clinical Site 1706
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-453
      • Clinical Site 1703
  • Pomeranian Voivodeship
    • Warszawa, Pomeranian Voivodeship, Poland, 02-507
      • Clinical Site 1701
    • Warszawa, Pomeranian Voivodeship, Poland, 02-962
      • Clinical Site 1705
  • Silesian Voivodeship
    • Ossy, Silesian Voivodeship, Poland, 42-624
      • Clinical Site 1704
• Slovakia
  • Presov
    • Svidník, Presov, Slovakia, 089 01
      • Clinical Site 2202
  • Trnava Region
    • Trnava, Trnava Region, Slovakia, 917 75
      • Clinical Site 2201
• Spain
  • Granada, Spain, 18012
    • Clinical Site 1802
  • Madrid, Spain, 28034
    • Clinical Site 1803
  • Seville, Spain, 41009
    • Clinical Site 1804
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Clinical Site 1801
• Turkey (Türkiye)
  • Gaziantep, Turkey (Türkiye), 27310
    • Clinical Site 2001
  • Samsun, Turkey (Türkiye), 55270
    • Clinical Site 2002
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Clinical Site 1022
    • Scottsdale, Arizona, United States, 85260
      • Clinical Site 1037
    • Tucson, Arizona, United States, 85704
      • Clinical Site 1026
  • California
    • Northridge, California, United States, 91325
      • Clinical Site 1032
    • Pomona, California, United States, 91767
      • Clinical Site 1019
    • Sacramento, California, United States, 95815
      • Clinical Site 1009
    • Santa Monica, California, United States, 90024
      • Clinical Site 1034
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Clinical Site 1011
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Clinical Site 1029
    • Coral Gables, Florida, United States, 33134
      • Clinical Site 1002
    • Maitland, Florida, United States, 32751
      • Clinical Site 1015
    • North Miami Beach, Florida, United States, 33162-4708
      • Clinical Site 1027
    • Tampa, Florida, United States, 33613
      • Clinical Site 1013
  • Georgia
    • Savannah, Georgia, United States, 31419
      • Clinical Site 1008
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Clinical Site 1014
  • Indiana
    • West Lafayette, Indiana, United States, 47906
      • Clinical Site 1028
  • Kentucky
    • Bowling Green, Kentucky, United States, 42104
      • Clinical Site 1031
    • Murray, Kentucky, United States, 42071
      • Clinical Site 1024
  • Massachusetts
    • Boston, Massachusetts, United States, 02115-5804
      • Clinical Site 1042
    • Boston, Massachusetts, United States, 02215
      • Clinical Site 1001
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Clinical Site 1030
    • Fort Gratiot, Michigan, United States, 48059
      • Clinical Site 1007
    • Oakland, Michigan, United States, 48328
      • Clinical Site 1041
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Clinical Site 1003
  • New York
    • Brooklyn, New York, United States, 10023
      • Clinical Site 1036
    • New York, New York, United States, 10003
      • Clinical Site 1016
    • The Bronx, New York, United States, 10467
      • Clinical Site 1023
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Clinical Site 1020
    • Cleveland, Ohio, United States, 44106
      • Clinical Site 1010
    • Dublin, Ohio, United States, 43016
      • Clinical Site 1017
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Clinical Site 1004
    • Pittsburgh, Pennsylvania, United States, 15213
      • Clinical Site 1035
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Site 1018
    • Providence, Rhode Island, United States, 02903
      • Clinical Site 1025
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Clinical Site 1005
  • Texas
    • Arlington, Texas, United States, 76011
      • Clinical Site 1012

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Patients will receive matching placebo.	Drug: Placebo; Matching placebo will be administered as a subcutaneous injection every 2 weeks.
Experimental: AVTX-009 Regimen 1; Patients will receive AVTX-009 regimen 1.	Drug: AVTX-009 Regimen 1; AVTX-009 will be administered as a subcutaneous injection every 4 weeks.
Experimental: AVTX-009 Regimen 2; Patients will receive AVTX-009 regimen 2.	Drug: AVTX-009 Regimen 2; AVTX-009 will be administered as a subcutaneous injection every 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieving HiSCR50	HiSCR50 is defined as at least a 50% 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
Proportion of patients achieving HiSCR90	HiSCR90 is defined as at least a 90% 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
Change from Baseline in International HS Severity Score System (IHS4)	IHS4 score is calculated by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild disease, 4 to 10 signifies moderate disease, and 11 or higher signifies severe disease.	Baseline (Day 1) and Week 16
Change from Baseline in total abscess and inflammatory nodule (AN) count	An abscess is a circumscribed collection of purulent exudates frequently associated with swelling, erythema, and other signs of inflammation, such as fluctuance, tenderness, and pain. An inflammatory nodule is a raised, deep-seated, three-dimensional, round nodule, greater than 10 mm in diameter. It is tender and erythematous without evidence of fluctuance.	Baseline (Day 1) and Week 16
Change from Baseline in draining fistula count	Draining fistula is defined as a pathologic passageway connecting to the skin surface from dermis or subcutaneous tissue that drains serous or purulent fluid, either spontaneously or by gentle palpation.	Baseline (Day 1) and Week 16
Percentage of patients achieving at least a 30% reduction and at least a 1-unit reduction from Baseline on a Numerical Rating Scale (NRS) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3 (NRS30)	The skin pain NRS is a single-item measure to capture the patient's self-reported skin pain severity by rating the worst level of skin pain in the last 24 hours as a number on a numerical rating scale from 0 (no pain) to 10 (worst pain imaginable).	Baseline (Day 1) and Week 16
Percentage of patients with flares	The number of patients with flares will be programmatically calculated based on the assessed lesion counts. A flare is defined as ≥ 25% increase in AN count plus an increase of ≥ 2 in AN count compared to Baseline.	From Baseline (Day 1) to Week 16
AVTX-009 anti-drug antibodies (ADA)	The incidence of patients with AVTX-009 anti-drug antibodies (ADA).	From Baseline (Day 1) to Week 20
Safety and tolerability of AVTX-009	Incidence of adverse events (AEs).	From Baseline (Day 1) to Week 20

Collaborators and Investigators

• Sponsor: Avalo Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Actual): February 23, 2026
• Study Completion (Actual): March 17, 2026

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: HS; Hidradenitis Suppurativa; FL-101; acne inversa; AVTX-009; LY2189102
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: AVTX-009-HS-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No