A Phase 2 interventional study of AVTX-009 Regimen 1 and AVTX-009 Regimen 2 in Hidradenitis Suppurativa, sponsored by Avalo Therapeutics, Inc.. Completed at 89 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Avalo Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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).
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:
The maximum clinical trial duration for each participant is 24 weeks.
284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.
This study's enrollment of 253 is above the median of 45 across 199 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →Avalo Therapeutics, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive AVTX-009 regimen 1.
Drug: AVTX-009 Regimen 1
Patients will receive AVTX-009 regimen 2.
Drug: AVTX-009 Regimen 2
Patients will receive matching placebo.
Drug: Placebo
AVTX-009 will be administered as a subcutaneous injection every 4 weeks.
AVTX-009 will be administered as a subcutaneous injection every 2 weeks.
Matching placebo will be administered as a subcutaneous injection every 2 weeks.
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.
Time frame: At Week 16
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: From Baseline (Day 1) to Week 16
AVTX-009 anti-drug antibodies (ADA)
The incidence of patients with AVTX-009 anti-drug antibodies (ADA).
Time frame: From Baseline (Day 1) to Week 20
Safety and tolerability of AVTX-009
Incidence of adverse events (AEs).
Time frame: From Baseline (Day 1) to Week 20
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: LY2189102
Avalo Therapeutics, Inc.