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Study of Lutikizumab compared to placebo in adults and adolescents (age 12 and older) with moderate to severe Hidradenitis Suppurativa

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on evaluating a treatment for Hidradenitis Suppurativa (HS), a chronic skin condition that causes painful bumps and abscesses in areas where skin rubs together. The study examines the effectiveness and safety of Lutikizumab (also known as ABT-981) compared to placebo in people with moderate to severe forms of the condition.

The treatment involves receiving either Lutikizumab or placebo through subcutaneous injection (an injection under the skin). The medication being tested is a biotechnology product that aims to reduce the signs and symptoms of moderate to severe Hidradenitis Suppurativa. The study will assess how well the treatment works in both adults and adolescents who have had inadequate results with previous treatments.

The study will measure several aspects of the condition, including reduction in the number of inflammatory bumps and draining wounds, improvement in pain levels, and changes in quality of life. The treatment period will last for several months to properly evaluate the medication's effectiveness. Throughout the study, participants will be closely monitored to ensure their safety and to track their response to the treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your diagnosis of moderate to severe Hidradenitis Suppurativa (HS) will be confirmed. This is a skin condition that must have been present for at least 6 months

    The doctor will check if you have at least 5 affected areas and HS lesions in at least two different body areas

    One of your affected areas must be classified as Hurley Stage II or higher

    Previous treatment with oral antibiotics for 12 weeks must have been unsuccessful or caused intolerance

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either lutikizumab or a placebo

    The medication will be given as an injection under the skin (subcutaneous injection)

    Neither you nor your doctor will know which treatment you are receiving

  3. Step 3

    16-week treatment period

    You will receive regular injections under the skin for 16 weeks

    At week 8, your pain levels will be evaluated using a rating scale

    The doctor will monitor changes in your condition, including:

    - Number and type of skin lesions

    - Drainage from affected areas

    - Skin-related pain

    - Quality of life impacts

    - Mobility

    - Emotional well-being

    - Related symptoms such as odor

  4. Step 4

    Evaluation of results

    At week 16, the main evaluation will check if there is at least 75% reduction in total affected areas

    Additional evaluations will include:

    - Whether you achieved 90% improvement in affected areas

    - Changes in drainage from affected areas

    - Overall quality of life improvements

    - Changes in pain levels

    - Any occurrence of condition flares (25% or more increase in affected areas)

Who can join the trial?

7 criteria

  • Must be at least 12 years old (may be higher in some countries - 16 or 18 years depending on local regulations)
  • Must have been diagnosed with moderate to severe Hidradenitis Suppurativa for at least 6 months before starting the study
  • Must have at least 5 inflammatory nodules or abscesses (AN count) at the start of the study
  • Must have skin lesions in at least two different body areas at the start of the study
  • Must have at least one affected body area that is classified as Hurley Stage II or higher (meaning more advanced disease with scarring and multiple connected tunnels under the skin)
  • Must have either:
    • Tried oral antibiotics for 12 weeks with unsatisfactory results, or
    • Been unable to tolerate oral antibiotics due to side effects

Who cannot join the trial?

14 criteria

  • Age below 12 years old
  • Active or chronic infections (a condition where harmful germs are present in the body)
  • History of cancer in the past 5 years
  • Current or recent treatment with biologics (special medications that affect the immune system) within the past 3 months
  • Severe liver disease (problems with the organ that processes substances in your body)
  • Severe kidney disease (problems with organs that filter waste from blood)
  • Uncontrolled diabetes (high blood sugar levels that are not well managed)
  • Pregnancy or breastfeeding
  • Participation in other clinical trials within the past 30 days
  • History of serious allergic reactions to similar medications
  • Significant heart problems or uncontrolled high blood pressure
  • Active substance abuse or addiction
  • Mental health conditions that could interfere with study participation
  • Use of medications that could interact with the study drug
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Investigated drugs

Lutikizumab (ABT-981) is an investigational medication designed to treat hidradenitis suppurativa, a chronic inflammatory skin condition. It works by targeting specific proteins in the body that cause inflammation. This medication is being studied to help reduce symptoms like painful bumps and abscesses in people with moderate to severe forms of the condition. It is administered through injections and represents a new potential treatment option for patients who haven't responded well to other therapies.

What is already known about the treatment

Lutikizumab (ABT-981) - A novel injectable biological medication that belongs to the class of monoclonal antibodies, specifically designed to target inflammatory processes in the body. This drug, administered through subcutaneous injection, works by blocking specific inflammatory proteins (IL-1α and IL-1β) involved in the development of Hidradenitis Suppurativa, a chronic inflammatory skin condition. Currently undergoing Phase 3 clinical trials, Lutikizumab represents a promising therapeutic option for patients aged 12 and older who suffer from moderate to severe forms of Hidradenitis Suppurativa, particularly when conventional treatments have proven insufficient. The medication's dual-targeting mechanism of action makes it unique among biological treatments, as it simultaneously inhibits two key inflammatory pathways involved in the disease process.

Investigated diseases

Hidradenitis Suppurativa - A chronic skin condition that causes small, painful lumps to form under the skin, typically in areas where skin rubs together, such as the armpits, groin, buttocks, and under the breasts. The condition begins with tender, swollen areas of skin that may look like pimples or boils. Over time, these lumps can grow larger, break open and drain pus, and may form tunnels under the skin connecting different areas. The condition tends to be long-lasting and can worsen over time, with new lumps forming as others heal. Hidradenitis Suppurativa affects the hair follicles and sweat glands, causing inflammation and scarring in the affected areas. The condition often follows a pattern of flare-ups and periods of remission.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510730-40-00Protocol codeM20-465Estimated enrolment1 280 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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