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

Launched by AVALO THERAPEUTICS, INC. · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called AVTX-009 for patients with moderate to severe Hidradenitis Suppurativa (HS), a skin condition that causes painful lumps and sores. The goal is to see if AVTX-009 is effective and safe compared to a placebo, which is an inactive treatment. This trial is currently recruiting participants aged 18 and older who have been experiencing HS symptoms for at least six months and have at least five painful lesions in different areas of their body.

To be eligible for this trial, participants should not have certain other serious skin conditions or infections that could interfere with the study. If you join the trial, you will receive either the new treatment or a placebo, and your symptoms will be closely monitored. This is an important opportunity to help understand how effective AVTX-009 could be for managing HS, and potentially help others with this challenging condition in the future.

Gender

ALL

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.