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Active Not RecruitingNCT06374212

Anifrolumab for Hidradenitis Suppurativa

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

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
University of North Carolina, Chapel Hill · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DRUGAnifrolumab900mg maintenance dose every 4 weeks for 12 weeks then 600mg loading dose every 4 weeks until week 20

Timeline

Start date
2024-06-21
Primary completion
2026-01-22
Completion
2026-04-01
First posted
2024-04-18
Last updated
2026-02-17

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06374212. Inclusion in this directory is not an endorsement.