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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
North Carolina
UNC Dermatology and Skin Cancer Center
RECRUITING
Chapel Hill
Contact Information
Primary
Erika Hanami
erika_hanami@med.unc.edu
984-974-3682
Time Frame
Start Date: 2024-06-21
Estimated Completion Date: 2026-05
Participants
Target number of participants: 15
Treatments
Experimental: Anifrolumab
Participants will receive anifrolumab (loading dose of 900mg) intravenously at the first visit, week 4 and week 8. Anifrolumab (maintenance dose of 600mg) will be administered intravenously for weeks 12, 16, and 20.
Related Therapeutic Areas
Sponsors
Collaborators: AstraZeneca
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov