Active not recruitingPHASE2INTERVENTIONAL

A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic Therapy

This research study is investigating an experimental drug called lutikizumab for adults with moderate to severe hidradenitis suppurativa (HS). HS is a painful, long-term skin condition causing lumps and scars, often under the arms or in the groin. The study has two main parts: one for people whose current anti-TNF treatments haven't been effective, and another for those who are new to biologic therapies. Participants will receive weekly injections of either lutikizumab or a dummy drug (placebo) to see if lutikizumab improves their HS symptoms and is safe. Regular hospital visits, medical checks, and questionnaires will monitor the drug's effects and any side effects. Involvement could mean more appointments than usual, but it offers a chance to try a new treatment.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AbbVie

Enrolment target

210

Start

28 Dec 2021

Estimated completion

01 Dec 2027

Hidradenitis Suppurativa

What is this study about?

This study is looking into a new medication called lutikizumab for adults who have a skin condition called hidradenitis suppurativa (HS). HS is a long-term and often painful condition where you get painful lumps, pus-filled spots, and scars in areas like your armpits, groin, and under your breasts. While some treatments, like anti-TNF therapies, can help, they don't work for everyone. This means there's a real need for new and better treatments.

This study aims to discover if lutikizumab can help people with moderate to severe HS when other treatments haven't worked, or for those who haven't tried certain modern 'biologic' medicines before. Lutikizumab is an investigational drug, which means it's still being tested and isn't yet available as a standard treatment. Comparing it to a placebo (a dummy drug with no active medicine) helps researchers understand its true effects.

The study is divided into two main parts. One part includes people whose anti-TNF treatments haven't been successful. The other part is for people who have HS but haven't yet tried a type of medicine called biologic therapy. By looking at these different groups, researchers hope to get a full picture of who might benefit most from lutikizumab and how it works.

Key takeaways

The study explores a new drug (lutikizumab) for moderate to severe HS.
It's for adults whose current treatments haven't been effective or who haven't tried certain modern therapies.
Participants will receive weekly injections, either the drug or a placebo.
Regular hospital visits, blood tests, and questionnaires are part of the study.
You might get access to a new treatment, but there are potential risks and increased time commitments.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and have been diagnosed with hidradenitis suppurativa (HS) for at least a year. You should also have at least five active lumps and inflamed areas of skin, and your HS needs to be present in at least two different body areas. Your doctor will confirm these things.

If you're taking part in the main study, you must have tried and not had enough success with anti-TNF treatments for your HS. If you're interested in the sub-study, you must be new to a type of treatment called biologic therapy for your HS. This means you haven't used biologics before.

You won't be able to join if you have other active skin conditions that might make it hard to properly check your HS, or if you've had certain skin infections needing strong medication in the last four weeks. The study team will review your medical history carefully to make sure it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with hidradenitis suppurativa (HS) for at least a year?
Do you have at least 5 active lumps and inflamed areas due to HS?
Is your HS present in at least two different body areas?
If interested in the main study, have you tried anti-TNF treatments for HS without enough success?
If interested in the sub-study, have you never had biologic therapy for your HS?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll either receive injections of lutikizumab or a placebo (a dummy drug). In the main study, you'll have weekly injections for 16 weeks. You'll have a 1 in 4 chance of receiving the placebo. If you're in the sub-study, you'll get weekly injections of lutikizumab for the first 15 weeks, and then either weekly or every other week for 36 weeks.

Taking part will mean you'll have regular visits to a hospital or clinic. These visits are important for the medical team to check your health, see how the treatment is working, and look for any side effects. You'll have medical assessments, blood tests, and will be asked to fill out questionnaires and keep a diary. Your participation could last for over a year (up to 52 weeks). If the treatment helps you and you meet certain criteria, you might be able to continue receiving lutikizumab for an additional 104 weeks in an optional long-term extension part of the study.

Potential risks and benefits

Taking part in a study like this means you might get access to a new treatment before it's widely available. The potential benefit is that lutikizumab could help improve your HS symptoms, especially if other treatments haven't worked for you. However, as with any medication, there are potential risks and side effects that the study team will explain to you. There's also a chance you might receive a placebo, meaning you wouldn’t get the active drug. Your involvement might mean more hospital visits and procedures than your usual care. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (54)

Medical Dermatology Specialists /ID# 240641
Verified postcode
Phoenix, United States
Mayo Clinic - Scottsdale /ID# 241030
Verified postcode
Scottsdale, United States
Burke Pharmaceutical Research /ID# 240811
Verified postcode
Hot Springs, United States
UCSF Fresno /ID# 240903
Verified postcode
Fresno, United States
Medderm Associates /ID# 240729
Verified postcode
San Diego, United States
Clinical Trials Research Institute /ID# 240642
Verified postcode
Thousand Oaks, United States
CCD Research, PLLC /ID# 240728
Verified postcode
Cromwell, United States
Skin Care Research Boca Raton /ID# 240758
Verified postcode
Boca Raton, United States
Apex Clinical Trials /ID# 248558
Verified postcode
Brandon, United States
GSI Clinical Research, LLC /ID# 240901
Verified postcode
Margate, United States
Florida International Rsrch cr /ID# 240902
Verified postcode
Miami, United States
Park Avenue Dermatology, PA /ID# 240807
Verified postcode
Orange Park, United States

Common questions

What is hidradenitis suppurativa (HS)?

HS is a long-term skin condition causing painful lumps, abscesses, and scars, often in places where skin rubs together, like armpits or groin.

What is lutikizumab?

Lutikizumab is an experimental drug being tested to see if it can help treat HS. It's not yet a standard approved treatment.

What is a 'placebo'?

A placebo is a dummy treatment that looks like the active drug but contains no medicine. It helps researchers accurately see if the real drug is effective.

What are 'anti-TNF' and 'biologic therapy'?

These are types of modern medicines used to treat inflammatory conditions like HS. Some people in this study will have already tried anti-TNF therapy without enough success, while others will be new to biologics.

How long will I be in the study?

Participation will involve regular visits for at least 16 weeks, and potentially up to 52 weeks or even longer (up to 3 years) if you qualify for an optional extension.