Anifrolumab for Hidradenitis Suppurativa

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.