Clinical trial NCT06603077: A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
HS
acne inversa
AVTX-009
LY2189102
FL-101
Lead sponsor: Avalo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
timeFrame: At Week 16
Secondary outcomes:
measure: Proportion of patients achieving HiSCR50
timeFrame: At Week 16
measure: Proportion of patients achieving HiSCR90
timeFrame: At Week 16
measure: Change from Baseline in International HS Severity Score System (IHS4)
timeFrame: Baseline (Day 1) and Week 16
measure: Change from Baseline in total abscess and inflammatory nodule (AN) count
timeFrame: Baseline (Day 1) and Week 16
measure: Change from Baseline in draining fistula count
timeFrame: Baseline (Day 1) and Week 16
measure: 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)
timeFrame: Baseline (Day 1) and Week 16
measure: Percentage of patients with flares
timeFrame: From Baseline (Day 1) to Week 16
measure: AVTX-009 anti-drug antibodies (ADA)
timeFrame: From Baseline (Day 1) to Week 20
measure: Safety and tolerability of AVTX-009
timeFrame: From Baseline (Day 1) to Week 20
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clinical Site 1022
state: Arizona
city: Tucson
country: United States
facility: Clinical Site 1026
state: Arizona
city: Northridge
country: United States
facility: Clinical Site 1032
state: California
city: Pomona
country: United States
facility: Clinical Site 1019
state: California
city: Sacramento
country: United States
facility: Clinical Site 1009
state: California
city: Washington
country: United States
facility: Clinical Site 1011
state: District of Columbia
city: Boca Raton
country: United States
facility: Clinical Site 1029
state: Florida
city: Coral Gables
country: United States
facility: Clinical Site 1002
state: Florida
city: Maitland
country: United States
facility: Clinical Site 1015
state: Florida
city: North Miami Beach
country: United States
facility: Clinical Site 1027
state: Florida
city: Tampa
country: United States
facility: Clinical Site 1013
state: Florida
city: Savannah
country: United States
facility: Clinical Site 1008
state: Georgia
city: Chicago
country: United States
facility: Clinical Site 1014
state: Illinois
city: West Lafayette
country: United States
facility: Clinical Site 1028
state: Indiana
city: Murray
country: United States
facility: Clinical Site 1024
state: Kentucky
city: Boston
country: United States
facility: Clinical Site 1001
state: Massachusetts
city: Ft. Gratiot
country: United States
facility: Clinical Site 1007
state: Michigan
city: Portsmouth
country: United States
facility: Clinical Site 1003
state: New Hampshire
city: Bronx
country: United States
facility: Clinical Site 1023
state: New York
city: Brooklyn
country: United States
facility: Clinical Site 1036
state: New York
city: New York
country: United States
facility: Clinical Site 1016
state: New York
city: Cincinnati
country: United States
facility: Clinical Site 1020
state: Ohio
city: Cleveland
country: United States
facility: Clinical Site 1010
state: Ohio
city: Dublin
country: United States
facility: Clinical Site 1017
state: Ohio
city: Philadelphia
country: United States
facility: Clinical Site 1004
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Site 1018
state: Rhode Island
city: Greenville
country: United States
facility: Clinical Site 1005
state: South Carolina
city: Arlington
country: United States
facility: Clinical Site 1012
state: Texas
city: Darlinghurst
country: Australia
facility: Clinical Site 1203
state: New South Wales
city: Westmead
country: Australia
facility: Clinical Site 1201
state: New South Wales
city: Carlton
country: Australia
facility: Clinical Site 1202
state: Victoria
city: Sofia
country: Bulgaria
facility: Clinical Site 1303
state: Sofia-Grad
city: Lovech
country: Bulgaria
facility: Clinical Site 1302
city: Pleven
country: Bulgaria
facility: Clinical Site 1301
city: Stara Zagora
country: Bulgaria
facility: Clinical Site 1304
city: Edmonton
country: Canada
facility: Clinical Site 1105
state: Alberta
city: Edmonton
country: Canada
facility: Clinical Site 1108
state: Alberta
city: Barrie
country: Canada
facility: Clinical Site 1103
state: Ontario
city: Hamilton
country: Canada
facility: Clinical Site 1104
state: Ontario
city: London
country: Canada
facility: Clinical Site 1107
state: Ontario
city: Toronto
country: Canada
facility: Clinical Site 1106
state: Ontario
city: Saskatoon
country: Canada
facility: Clinical Site 1101
state: Saskatchewan
city: Praha 10
country: Czechia
facility: Clinical Site 1401
state: Prague
city: Praha 5
country: Czechia
facility: Clinical Site 1402
state: Prague
city: Antony
country: France
facility: Clinical Site 1503
state: Hauts-de-Seine
city: Paris
country: France
facility: Clinical Site 1504
state: Ile-de-France
city: Amiens
country: France
facility: Clinical Site 1505
state: Picardie
city: Rouen Cedex
country: France
facility: Clinical Site 1501
state: Seine-Maritime
city: Erlangen
country: Germany
facility: Clinical Site 1606
state: Bayern
city: Torrette
country: Italy
facility: Clinical Site 1901
state: Ancona
city: Rozzano
country: Italy
facility: Clinical Site 1903
state: Milano
city: Milano
country: Italy
facility: Clinical Site 1908
city: Roma
country: Italy
facility: Clinical Site 1907
city: Roma
country: Italy
facility: Clinical Site 1904
city: Wroclaw
country: Poland
facility: Clinical Site 1702
state: Kujawsko-Pomorskie
city: Bialystok
country: Poland
facility: Clinical Site 1703
state: Podlaskie
city: Warszawa
country: Poland
facility: Clinical Site 1701
state: Pomorskie
city: Warszawa
country: Poland
facility: Clinical Site 1705
state: Pomorskie
city: Ossy
country: Poland
facility: Clinical Site 1704
state: Slaskie
city: Svidnik
country: Slovakia
facility: Clinical Site 2202
state: Presovsky Kraj
city: Trnava
country: Slovakia
facility: Clinical Site 2201
state: Trnavsky kraj
city: Manises
country: Spain
facility: Clinical Site 1801
state: Valencia
city: Granada
country: Spain
facility: Clinical Site 1802
city: Madrid
country: Spain
facility: Clinical Site 1803
city: Sevilla
country: Spain
facility: Clinical Site 1804
city: Gaziantep
country: Turkey
facility: Clinical Site 2001
Study officials:
References: