Trials / Active Not Recruiting
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
| Type | Name | Description |
|---|---|---|
| DRUG | Anifrolumab | 900mg 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
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06374212. Inclusion in this directory is not an endorsement.