Anifrolumab for Hidradenitis Suppurativa

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called anifrolumab to see if it can effectively treat Hidradenitis Suppurativa (HS), a skin condition that causes painful lumps and inflammation. The study will last about 40 weeks and includes a screening phase to determine if participants are eligible, a 24-week treatment phase, and a follow-up phase. Participants will receive the study drug through an intravenous (IV) infusion and will visit the clinic regularly during treatment to complete questionnaires about how HS affects their daily life and to receive medical evaluations.

To participate, individuals must be at least 18 years old and have a diagnosis of HS for at least six months, with at least five active lesions. They should not be on certain medications, such as antibiotics, and must not have any serious infections or other health conditions that would interfere with the study. Participants can expect to visit the clinic every two weeks initially, then monthly, and will be monitored after each infusion to ensure their safety. This trial is currently recruiting participants, and it's a great opportunity for those looking for new treatment options for HS.

Gender

ALL

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.