ACTIVE_NOT_RECRUITING

Anifrolumab for Hidradenitis Suppurativa

Conditions

Hidradenitis Suppurativa Acne Inversa Hidradenitis HS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-06-21

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06374212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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.

Inclusion Criteria

Exclusion 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)

* 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.

Contacts and Locations

Principal Investigator

Christopher Sayed, MD

PRINCIPAL_INVESTIGATOR

UNC Dermatology and Skin Cancer Center

Study Locations (Sites)

UNC Dermatology and Skin Cancer Center

Chapel Hill, North Carolina, 27516

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Christopher Sayed, MD, PRINCIPAL_INVESTIGATOR, UNC Dermatology and Skin Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-21

Study Completion Date2026-04

Study Record Updates

Study Start Date2024-06-21

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Hidradenitis Suppurativa
Acne Inversa
Hidradenitis