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.
1Initial 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
2Treatment 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
316-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
4Evaluation 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 Study?
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 Study?
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
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.
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.
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