Anifrolumab for Hidradenitis Suppurativa (NCT06374212) | Clinical Trial Compass
CompletedPhase 2
Anifrolumab for Hidradenitis Suppurativa
United States15 participantsStarted 2024-06-21
Plain-language summary
This clinical trial aims to study if a drug called anifrolumab works to treat Hidradenitis Suppurativa (HS) as well as its effect in quality of life before and after treatment. Anifrolumab is a monoclonal antibody that inhibits several processes that have been shown to be involved in the development of HS.
The study lasts approximately 40 weeks separated into a screening, treatment, and follow-up phase. Researchers determine if it is safe for the you to receive the drug and if you are eligible for the study during Screening. If eligible for the study, the treatment phase lasts 24 weeks (or six months) with one follow-up visit 12 weeks after the last visit in the treatment phase.
During the treatment phase, participants will be asked to come to clinic every two weeks for the first month of treatment, and monthly thereafter for a total of eight treatment visits. Participants will be asked to:
* Complete questionnaires asking about the effect of HS in their daily lives and their perception of HS and treatment received.
* Receive related medical evaluation
* Receive the study drug intravenously
* Stay 20 minutes after the infusion for monitoring
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Must be at least 18 years of age and older.
* Diagnosis or history of clinical features consistent with hidradenitis suppurativa for ≥6 months prior to baseline visit
* Must have an inflammatory lesion count of ≥5 at the time of screening
* Must be off oral and intravenous antibiotics or on a stable course of oral antibiotics for ≥28 days prior to the baseline visit. Allowable antibiotics during treatment course are topical clindamycin, topical chlorhexidine gluconate, oral doxycycline, oral minocycline, or oral clindamycin.
* Must have hidradenitis suppurativa in at least two distinct body locations, i.e. left and right groin
* Does not have a history of or current Tuberculosis (TB)
Key Exclusion Criteria:
* Have had surgical intervention beyond incision and drainage in the last 8 weeks or have open surgical wounds
* Planning a major elective surgery during the time of the study.
* Taking other immunomodulatory or biologic treatment for Hidradenitis Suppurativa
* Previous treatment with anifrolumab for any reason.
* Are pregnant, lactating, or intend to become pregnant or lactate for up to 16 weeks following the last dose of study drug upon signing the Informed Consent Form (ICF)
* Severe herpes zoster infection
* Known history of allergy or reaction to any component of the study drug
* History of cancer (some cases of basal cell carcinoma and squamous cell carcinoma of the skin as well as cervical carcinoma in situ may be eligible).
* Primary im…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants achieving at least a Hidradenitis Suppurativa Clinical Response score of 50 (HiSCR 50) at 12 weeks