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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06603077




Registration number
NCT06603077
Ethics application status
Date submitted
17/09/2024
Date registered
19/09/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa
Scientific 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)
Secondary ID [1] 0 0
AVTX-009-HS-201
Universal Trial Number (UTN)
Trial acronym
LOTUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AVTX-009 Regimen 1
Treatment: Drugs - AVTX-009 Regimen 2
Treatment: Drugs - Placebo

Experimental: AVTX-009 Regimen 1 - Patients will receive AVTX-009 regimen 1.

Experimental: AVTX-009 Regimen 2 - Patients will receive AVTX-009 regimen 2.

Placebo comparator: Placebo - Patients will receive matching placebo.


Treatment: Drugs: AVTX-009 Regimen 1
AVTX-009 will be administered as a subcutaneous injection every 4 weeks.

Treatment: Drugs: AVTX-009 Regimen 2
AVTX-009 will be administered as a subcutaneous injection every 2 weeks.

Treatment: Drugs: Placebo
Matching placebo will be administered as a subcutaneous injection every 2 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Timepoint [1] 0 0
At Week 16
Secondary outcome [1] 0 0
Proportion of patients achieving HiSCR50
Timepoint [1] 0 0
At Week 16
Secondary outcome [2] 0 0
Proportion of patients achieving HiSCR90
Timepoint [2] 0 0
At Week 16
Secondary outcome [3] 0 0
Change from Baseline in International HS Severity Score System (IHS4)
Timepoint [3] 0 0
Baseline (Day 1) and Week 16
Secondary outcome [4] 0 0
Change from Baseline in total abscess and inflammatory nodule (AN) count
Timepoint [4] 0 0
Baseline (Day 1) and Week 16
Secondary outcome [5] 0 0
Change from Baseline in draining fistula count
Timepoint [5] 0 0
Baseline (Day 1) and Week 16
Secondary outcome [6] 0 0
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)
Timepoint [6] 0 0
Baseline (Day 1) and Week 16
Secondary outcome [7] 0 0
Percentage of patients with flares
Timepoint [7] 0 0
From Baseline (Day 1) to Week 16
Secondary outcome [8] 0 0
AVTX-009 anti-drug antibodies (ADA)
Timepoint [8] 0 0
From Baseline (Day 1) to Week 20
Secondary outcome [9] 0 0
Safety and tolerability of AVTX-009
Timepoint [9] 0 0
From Baseline (Day 1) to Week 20

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Clinical Site 1203 - Darlinghurst
Recruitment hospital [2] 0 0
Clinical Site 1202 - Carlton
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
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New York
Country [13] 0 0
United States of America
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Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Rhode Island
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia-Grad
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Lovech
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Pleven
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Stara Zagora
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Saskatchewan
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Prague
Country [26] 0 0
France
State/province [26] 0 0
Hauts-de-Seine
Country [27] 0 0
France
State/province [27] 0 0
Picardie
Country [28] 0 0
France
State/province [28] 0 0
Seine-Maritime
Country [29] 0 0
Italy
State/province [29] 0 0
Ancona
Country [30] 0 0
Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Italy
State/province [31] 0 0
Roma
Country [32] 0 0
Poland
State/province [32] 0 0
Kujawsko-Pomorskie
Country [33] 0 0
Poland
State/province [33] 0 0
Podlaskie
Country [34] 0 0
Poland
State/province [34] 0 0
Pomorskie
Country [35] 0 0
Poland
State/province [35] 0 0
Slaskie
Country [36] 0 0
Slovakia
State/province [36] 0 0
Presovsky Kraj
Country [37] 0 0
Spain
State/province [37] 0 0
Valencia
Country [38] 0 0
Spain
State/province [38] 0 0
Granada
Country [39] 0 0
Spain
State/province [39] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Avalo Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mittie Doyle, MD, FACR
Address 0 0
Country 0 0
Phone 0 0
610-254-4201
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06603077