Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)
This study is investigating a new medicine called tulisokibart for individuals living with moderate to severe hidradenitis suppurativa (HS). HS is a long-term skin condition causing painful lumps and abscesses. This research aims to find out if tulisokibart is safe and effective in reducing the symptoms of HS. Participants will either receive the new medicine or a dummy medicine (placebo) for 16 weeks. The main goal is to see if more people taking tulisokibart experience a significant improvement in their HS compared to those taking the placebo. This is a Phase 2 study, meaning it's still in the earlier stages of testing new medicines.
At a glance
What is this study about?
Hidradenitis suppurativa (HS) is a long-term skin condition that causes painful lumps, boils, and abscesses, often in areas where skin rubs together, like the armpits or groin. These can sometimes burst and produce an unpleasant smell. It can be a very challenging condition to live with, and current treatments don't work for everyone.
Researchers are always looking for new and better ways to treat HS. This particular study is testing a new medication called tulisokibart. It's a 'Phase 2' study, which means it’s an important step in determining if the new medicine works and is safe enough to be tested on larger groups of people. The study aims to see if tulisokibart can help reduce the number and severity of HS symptoms in people who have moderate to severe forms of the condition.
To find out if tulisokibart is effective, some participants will receive the new medicine and others will receive a 'placebo', which looks exactly like the medicine but contains no active ingredients. This allows researchers to compare the effects of the new medicine against no treatment at all. The study will last for a total of 16 weeks in the first part, followed by a longer period of up to 100 weeks where all participants may receive the active medication, if they wish to continue.
Key takeaways
- This study is testing a new drug for moderate to severe hidradenitis suppurativa.
- It's a Phase 2 study, looking at the medicine's safety and effectiveness.
- Participants will receive either the new drug or a dummy medicine (placebo) at first.
- The main treatment period lasts 16 weeks, with potential for longer follow-up.
- Regular clinic visits and health checks will be part of taking part.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you would generally need to be an adult between 18 and 75 years old and have had hidradenitis suppurativa (HS) for at least six months. Your HS should be classed as moderate to severe, meaning you have a certain number of painful lumps or active spots in specific areas, and it hasn't responded well to standard antibiotic treatments, or you can't take those antibiotics.
There are also some reasons why you might not be able to join. For example, if you have other serious skin conditions that might make it hard to check your HS, or if you have certain other serious health issues like uncontrolled immune conditions, recent cancer, or specific infections like hepatitis or HIV. If you've recently had major surgery or are planning one, or if you've had specific treatments for your HS like laser therapy within the last six weeks, you probably wouldn't be eligible.
The research team will carefully review all your medical information to decide if this study is the right fit for you. It's important that joining the study wouldn't put your health at risk or interfere with the study's results.
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 between 18 and 75 years old?
- Have you had hidradenitis suppurativa (HS) for at least 6 months?
- Is your HS considered moderate to severe, with lumps/spots in at least two different body areas?
- Have standard HS antibiotics not worked well for you, or can you not take them?
- Do you have fewer than 20 draining tunnels on your skin?
- Do you not have certain other serious health conditions like recent cancer or active infections?
What does participation involve?
If you decide to take part, you would first go through a screening process to make sure the study is right for you. If you qualify, you'll either receive the new medicine, tulisokibart, or a dummy medicine (placebo) for the first 16 weeks. Neither you nor the study team will know which one you are receiving during this time.
During these 16 weeks, you would have regular visits to the clinic for check-ups, assessments of your HS symptoms, and to ensure your safety. These visits will involve physical examinations, blood tests, and discussions about how you're feeling and any changes in your HS. After the initial 16 weeks, if you choose to continue and meet certain criteria, you could enter a longer period of up to 100 weeks where you would likely receive the active tulisokibart medication, with continued monitoring and follow-up visits. The total time you could be involved in the study is approximately two years.
Potential risks and benefits
Locations (68)
- Cahaba Dermatology & Skin Health Center ( Site 0012)Verified postcodeBirmingham, United States
- Medical Dermatology Specialists ( Site 0027)Verified postcodePhoenix, United States
- Northwest Arkansas Clinical Trials Center, PLLC ( Site 0049)Verified postcodeRogers, United States
- Northridge Clinical Trials ( Site 0004)Verified postcodeNorthridge, United States
- Integrative Skin Science and Research ( Site 0015)Verified postcodeSacramento, United States
- Olympian Clinical Research ( Site 0010)Verified postcodeTampa, United States
- Skin Care Physicians of Georgia ( Site 0033)Verified postcodeMacon, United States
- Dawes Fretzin Clinical Research Group, LLC ( Site 0025)Verified postcodeIndianapolis, United States
- Beth Israel Deaconess Medical Center ( Site 0044)Verified postcodeBoston, United States
- Revival Research Institute, LLC ( Site 0005)Verified postcodeTroy, United States
- Mount Sinai Doctors - East 85th Street ( Site 0050)Verified postcodeNew York, United States
- DJL Clinical Research, PLLC ( Site 0021)Verified postcodeCharlotte, United States
Common questions
What is hidradenitis suppurativa (HS)?
HS is a chronic skin condition that causes painful lumps, boils, and abscesses, often in areas where skin rubs together.
What is tulisokibart?
Tulisokibart is a new medicine being tested to see if it can help treat moderate to severe hidradenitis suppurativa.
What is a 'placebo'?
A placebo is a dummy medicine that looks like the real treatment but contains no active drug. It helps researchers compare the new medicine's effects.
How long will the study last?
The main part of the study where you might receive the new medicine or placebo lasts 16 weeks, followed by an optional longer period of up to 100 weeks.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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