Clinical trial NCT06374212: Anifrolumab for Hidradenitis Suppurativa
Official title: A Prospective Open-label Trial Examining the Efficacy and Safety of Anifrolumab for Hidradenitis Suppurativa (HS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Acne Inversa
Hidradenitis
Keywords: HS
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2024-04-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All study participants, if eligible, will receive the study drug (anifrolumab).
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Percentage of participants achieving at least a Hidradenitis Suppurativa Clinical Response score of 50 (HiSCR 50) at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of participants achieving a HiSCR 50 at 24 weeks
timeFrame: 24 weeks
measure: Percentage of participants who achieve a Hidradenitis Suppurativa Clinical Response score of 75 (HiSCR 75) at 12 weeks
timeFrame: 12 weeks
measure: Percentage of participants who achieve a HiSCR 75 at 24 weeks of treatment.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Dermatology and Skin Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Dermatology and Skin Cancer Center
name: Christopher Sayed, MD
role: PRINCIPAL_INVESTIGATOR
References: