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AVTX-009 for Hidradenitis Suppurativa (LOTUS Trial)

Phase 2
Recruiting
Research Sponsored by Avalo Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 5 inflammatory lesions in at least 2 distinct anatomical areas, at least 1 of which is Hurley Stage 2 or 3.
Be older than 18 years old
Must not have
Has severe, progressive and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or immunosuppressive disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day 1) to week 20

Summary

"This trial aims to see if AVTX-009 is effective and safe for treating moderate to severe Hidradenitis Suppurativa compared to a placebo."

Who is the study for?
This trial is for individuals with moderate to severe Hidradenitis Suppurativa (HS). Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to the study's procedures.
What is being tested?
The study tests the effectiveness and safety of AVTX-009 in two different regimens against a placebo. Participants will be randomly assigned to receive either one of the AVTX-009 regimens or a placebo.
What are the potential side effects?
While specific side effects are not listed, clinical trials like this often monitor for reactions at injection sites, allergic responses, general discomforts such as headaches or nausea, and any other unexpected health changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have at least 5 inflamed areas on my body, with one being moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have severe or worsening kidney, liver, blood, hormone, lung, heart, nerve, or immune diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day 1) to week 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) to week 20 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Secondary study objectives
AVTX-009 anti-drug antibodies (ADA)
Change from Baseline in International HS Severity Score System (IHS4)
Change from Baseline in draining fistula count
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: AVTX-009 Regimen 2Experimental Treatment1 Intervention
Patients will receive AVTX-009 regimen 2.
Group II: AVTX-009 Regimen 1Experimental Treatment1 Intervention
Patients will receive AVTX-009 regimen 1.
Group III: PlaceboPlacebo Group1 Intervention
Patients will receive matching placebo.

Find a Location

Who is running the clinical trial?

Avalo Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
1,926 Total Patients Enrolled
~120 spots leftby Jun 2026
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