Can anifrolumab calm the painful boils of HS? a new trial seeks answers.
NCT ID NCT06374212
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This study tests whether anifrolumab, an antibody drug, can reduce skin abscesses and nodules in people with hidradenitis suppurativa (HS). Fifteen adults with moderate-to-severe HS will receive the drug intravenously over 24 weeks. The main goal is to see if at least half of participants achieve a 50% reduction in inflammatory lesions by week 12, while also monitoring safety and quality of life.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
15 people
The number who actually took part.
- Started
-
Jun 2024
- Finished
-
Jul 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 immunodeficiency, splenectomy, or any underlying condition that predisposes participants to infection, or a positive HIV test. * Active Hepatitis * Clinical Cytomegalovirus or Epstein-Barr infection that has not completely resolved within 12 weeks prior to signing the informed consent. * Opportunistic infection that required hospitalization or intravenous antimicrobial treatment within 3 years of baseline. * Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis) within 8 weeks prior to signing the informed consent. * Any history of severe COVID-19 infection (e.g. prolonged hospitalization \[hospitalization for observational purposes is not exclusionary\]) or any prior COVID-19 infection with documented long COVID-19 and/or clinically significant unresolved sequelae. Any mild/asymptomatic infections COVID-19 infection (lab confirmed or suspected based on clinical symptoms) within the last 6 weeks prior to first dosing. * Abnormal laboratory tests indicating severe anemia, severely impaired liver function or immunosuppression. * History of, or current diagnosis of, catastrophic anti-phospholipid syndrome within 1 year prior to signing the informed consent. (Other degrees of anti-phospholipid syndrome that is adequately controlled by anticoagulants or aspirin for at least 12 weeks may be eligible). * History of or evidence of suicidal ideation within the past 6 months or any suicidal behavior within the past 12 months or recurrent behavior in the participant's lifetime. Other protocol-specific inclusion/exclusion criteria may apply.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acne inversa are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, 27516, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Weight-Loss drug also calm a painful skin disease?
- Viruses that kill bacteria: a new weapon against superbugs?
- Can an injected drug calm the painful flares of hidradenitis suppurativa?
- Nanobody drug tested against painful skin condition
- Can a mediterranean diet tame hidradenitis suppurativa?
- Can we predict the path of chronic skin disease?