Anifrolumab for Hidradenitis Suppurativa
NCT06374212 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2026-02-17
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
- Hidradenitis Suppurativa
- Acne Inversa
- Hidradenitis
Interventions
- DRUG
-
Anifrolumab
900mg maintenance dose every 4 weeks for 12 weeks then 600mg loading dose every 4 weeks until week 20
Sponsors & Collaborators
- collaborator INDUSTRY
-
University of North Carolina, Chapel Hill
lead OTHER
Principal Investigators
-
Christopher Sayed, MD · UNC Dermatology and Skin Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-21
- Primary Completion
- 2026-01-22
- Completion
- 2026-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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