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Anifrolumab for Hidradenitis Suppurativa | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Anifrolumab for Hidradenitis Suppurativa

A Prospective Open-label Trial Examining the Efficacy and Safety of Anifrolumab for Hidradenitis Suppurativa (HS)

NCT06374212•University of North Carolina, Chapel Hill

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)

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
+7 more criteria

Locations (1)

UNC Dermatology and Skin Cancer Center

Chapel Hill, North Carolina, United States

Key Dates

Start Date

June 21, 2024

Primary Completion Date

January 22, 2026

Completion Date

April 1, 2026

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Hidradenitis SuppurativaAcne InversaHidradenitis

Interventions

Anifrolumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Anifrolumab for Hidradenitis Suppurativa

Inclusion Criteria

Exclusion Criteria

A Study With CIT-013 in HS Patients

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

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Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) in Routine Clinical Practice in the Russian Federation

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