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Can anifrolumab calm the painful boils of HS? a new trial seeks answers.

NCT ID NCT06374212

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tests whether anifrolumab, an antibody drug, can reduce skin abscesses and nodules in people with hidradenitis suppurativa (HS). Fifteen adults with moderate-to-severe HS will receive the drug intravenously over 24 weeks. The main goal is to see if at least half of participants achieve a 50% reduction in inflammatory lesions by week 12, while also monitoring safety and quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

15 people

The number who actually took part.

Started

Jun 2024

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UNC Dermatology and Skin Cancer Center

    Chapel Hill, North Carolina, 27516, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.