Using anifrolumab to treat Hidradenitis Suppurativa
A Prospective Open-label Trial Examining the Efficacy and Safety of Anifrolumab for Hidradenitis Suppurativa (HS)
This study is testing if a new medication called anifrolumab can help improve the symptoms and quality of life for people with Hidradenitis Suppurativa.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Drugs / interventions | anifrolumab |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06374212 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of anifrolumab, a monoclonal antibody, in treating Hidradenitis Suppurativa (HS) and its impact on patients' quality of life. The study spans approximately 40 weeks, including a screening phase to determine eligibility, a 24-week treatment phase, and a follow-up visit 12 weeks post-treatment. Participants will attend clinic visits every two weeks for the first month and monthly thereafter, during which they will complete questionnaires regarding the effects of HS on their daily lives. The trial aims to assess both the safety and efficacy of the drug in eligible patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of Hidradenitis Suppurativa for at least six months and an inflammatory lesion count of five or more.
Not a fit: Patients with recent surgical interventions or those currently on other immunomodulatory treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from Hidradenitis Suppurativa.
How similar studies have performed: While this approach is novel for Hidradenitis Suppurativa, similar monoclonal antibody treatments have shown promise in other inflammatory conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chapel Hill, North Carolina
- UNC Dermatology and Skin Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Sayed, MD — UNC Dermatology and Skin Cancer Center
- Study coordinator: Erika Hanami
- Email: erika_hanami@med.unc.edu
- Phone: 984-974-3682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.