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A study of an investigational oral medicine for teenagers with hidradenitis suppurativa
This study looks at whether an investigational oral medicine, which acts on a specific pathway in the immune system, is safe for teenagers with moderate to severe hidradenitis suppurativa, how the body processes it, and what effect it has on the condition. Hidradenitis suppurativa often begins in the teenage years, and fewer treatments have been studied in this age group than in adults.
| Condition | Hidradenitis suppurativa, moderate to severe |
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| Age range | 12 to under 18 years |
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| Phase | Phase 2 |
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| Design | Open label, meaning everyone taking part knows which medicine they are receiving |
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| What is measured | Safety, how the body processes the medicine (pharmacokinetics), and effect on the condition |
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| Sponsor | Incyte |
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| Registry | NCT07213973 |
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| Status | Recruiting |
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| Contact | research@dermcare.ca or 905 625 5600 |
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Read about hidradenitis suppurativa and the standard treatments available at DermCare.
Questions the research team may ask
Every study has its own entry criteria, set out in a protocol approved by a research ethics board. The questions below are the ones the research team commonly asks first for each condition, so you can think about your answers before you get in touch. Answering yes does not mean a study is right for you, and answering no does not always rule you out.
Hidradenitis suppurativa
- Has a doctor diagnosed you with hidradenitis suppurativa?
- Have you had it for at least six months?
- Do you currently have painful lumps, abscesses or draining tunnels, and in how many areas of the body?
- Have you tried at least one prescription treatment for it, such as antibiotics?
- Are you currently on a biologic injection or another prescription medicine for it?
About hidradenitis suppurativa and how it is treated
Psoriasis
- Has a doctor diagnosed you with psoriasis, and do you know which type?
- Have you had it for at least six months?
- Roughly how much of your skin is affected, and does it involve the scalp, nails, hands or feet?
- Have you tried prescription creams, phototherapy, or a pill or injection for psoriasis?
- Do you also have joint pain, or a diagnosis of psoriatic arthritis?
About psoriasis and how it is treated
Eczema and atopic dermatitis
- Has a doctor diagnosed you or your child with atopic dermatitis, the most common form of eczema?
- Has it been present for at least six months?
- Have prescription creams or ointments been tried, and did they keep it under control?
- How much does the itch affect your sleep and daily life?
- Have you used phototherapy, or a pill or injection, for eczema?
About eczema and atopic dermatitis and how it is treated
Vitiligo
- Has a doctor diagnosed you with vitiligo?
- Which areas are affected, for example the face, hands or body?
- Have the patches changed or spread in the past year?
- Have you used prescription creams or phototherapy for vitiligo?
About vitiligo and how it is treated
Acne
- Has a doctor diagnosed you with acne, and is it on the face only or also on the chest and back?
- On a typical day, roughly how many spots, bumps or deeper lumps do you have?
- Have you tried prescription creams or antibiotics for acne?
- Are you currently taking isotretinoin or a hormonal treatment?
About acne and how it is treated
Chronic hives (urticaria)
- Has a doctor diagnosed you with chronic hives, also called chronic urticaria?
- Have the hives come and gone for at least six weeks?
- Do you take an antihistamine every day, and does it control the hives?
- Have you had swelling of the lips, eyes or face?
- Has a trigger been found, or do the hives appear without a known cause?
About chronic hives and how it is treated
Asked in almost every study
- Your age. Each study sets its own age range. Some include teenagers, most are for adults only.
- Your other health conditions and the medicines you take, including over the counter products.
- Whether you are pregnant, breastfeeding or planning a pregnancy.
- Whether you have taken part in another clinical study in the past few months.
- Whether you can come to the clinic in Mississauga for visits on a set schedule.
The age range, the exact criteria and whether a study suits you are decided by the study team for each study.
Alongside your care, never instead of it
DermCare offers the full range of standard treatment for every condition listed here, including prescription treatments, phototherapy and systemic and biologic therapy. A study is an additional option that some patients choose to explore. An investigational treatment is still being tested: it may help, it may not, and it can have side effects. The research team and your own physician can help you weigh that up.
What taking part involves
Every study is different, and the study team will go through the specifics with you. In general terms, taking part in a clinical study at DermCare includes the following.
Initial enquiry
You or a parent or guardian contacts the research team. A coordinator asks some basic questions, like the ones above, and answers yours. No commitment is made at this stage.
Informed consent
Before anything else happens, you receive a written consent form that explains the purpose of the study, what will happen, the possible risks and benefits, and your rights. You have time to read it, ask questions and discuss it with family or your own physician. For participants under 18, a parent or guardian gives consent and the young person gives their own agreement.
Screening
Screening confirms whether you meet the study's entry criteria. It usually involves a medical history, an examination, and tests such as blood work. Not everyone who is screened is eligible, and being ineligible for a study says nothing about your health or your care.
Study visits
Participants come to the clinic on a set schedule for check ups, tests and the study treatment. Visits are more frequent than routine care. The schedule is in the consent form so you can judge whether it is manageable before you decide.
Oversight and your right to stop
Each study is reviewed and monitored by an independent research ethics board and carried out under Health Canada regulation. You may stop at any time, for any reason, without giving one, and your care at DermCare continues as before.
About this page
This page is for information only. Eligibility for any study is decided by the study team according to that study's approved protocol.
For referring physicians
If a patient may be interested in a study, you or the patient can contact the research team directly. Please do not send a referral for a study itself. Patients who need dermatology assessment regardless of a study should be referred in the usual way. How to refer.
Frequently asked questions
Do I have to be a patient of DermCare to take part?
No. Anyone can ask. You do not need a referral to contact the research team. If you turn out to need a dermatology assessment outside the study, a referral can be arranged at that point.
Will I still get my usual treatment?
Your standard care continues whether or not you take part. Some studies ask you to pause or avoid certain medicines for a time, and the research team explains this clearly before you decide.
Will my own doctor know?
With your permission, your family physician and any treating specialist are told that you are taking part, so that your care can be coordinated. This is discussed during consent.
What happens when a study ends?
The consent form explains what happens to your treatment at the end of the study. The study physician will discuss ongoing care with you before the study finishes.
Is my information kept private?
Yes. Study data are identified by a code rather than your name, and access is limited to the study team, the sponsor's monitors and regulators as described in the consent form. Personal health information is handled under Ontario privacy law.
