Hidradenitis suppurativa in adolescents
Now recruiting
A Phase 2, open label study evaluating the safety, pharmacokinetics and efficacy of an investigational oral therapy in adolescents aged 12 to under 18 with moderate to severe hidradenitis suppurativa.
| Registry identifier | NCT07213973 |
|---|---|
| Phase | Phase 2 |
| Design | Open label. All participants receive the investigational therapy. There is no placebo. |
| Condition | Moderate to severe hidradenitis suppurativa |
| Age range | 12 to under 18 years |
| What is measured | Safety, how the body processes the medicine (pharmacokinetics), and effect on the condition (efficacy) |
| Sponsor | Incyte |
| Status | Recruiting |
| Site | DermCare Clinic, Mississauga |
| Contact | research@dermcare.ca or 905 625 5600 |
Hidradenitis suppurativa is a long term inflammatory condition causing painful nodules, abscesses and tunnels under the skin, most often in the armpits, groin and under the breasts. It often begins in adolescence, and treatment options for younger patients have been limited. This study looks at whether an oral medicine that targets a specific pathway in the immune system is safe and helpful in this age group. Further detail is on the public registry at clinicaltrials.gov under the identifier above.
Read more about hidradenitis suppurativa and how it is treated at DermCare.
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 to see whether the study might be suitable, and answers yours. No commitment is made at this stage.
Informed consent
Before any study procedure, 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 assent.
Screening
Screening confirms whether you meet the study's entry criteria. It usually involves a medical history, 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 attend the clinic on a set schedule for assessments, tests and medication. Visits are more frequent than routine care. The schedule is set out in the consent form so you can judge whether it is manageable before you decide.
Oversight and your right to withdraw
The study is reviewed and monitored by an independent research ethics board and conducted under Health Canada regulation and Good Clinical Practice. You may withdraw at any time, for any reason, without giving one, and your ongoing care at DermCare is not affected.
About this page
This page is informational only and is not itself a recruitment advertisement. Recruitment materials used by the study team, including any advertising, have been reviewed and approved by a research ethics board. Eligibility is determined by the study physician according to the approved protocol.
Who to contact
Patients, parents and referring physicians can contact the research team at research@dermcare.ca or by calling 905 625 5600 and asking for the research team. You do not need a new referral to enquire about a study. If a patient is not already known to the clinic and turns out to need assessment outside the study, a referral can be arranged at that point.
For referring physicians
If you have an adolescent patient with moderate to severe hidradenitis suppurativa who may be interested, you or the family can contact the research team directly. Please do not send a referral for the study itself. Patients who need dermatology assessment regardless of the study should be referred in the usual way. How to refer.