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Monoclonal Antibodies

Anifrolumab for Hidradenitis Suppurativa

Phase 2
Recruiting
Led By Christopher Sayed, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be at least 18 years of age and older
Must have hidradenitis suppurativa in at least two distinct body locations, i.e. left and right groin
Must not have
Taking other immunomodulatory or biologic treatment for Hidradenitis Suppurativa
Have had surgical intervention beyond incision and drainage in the last 8 weeks or have open surgical wounds
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if a drug called anifrolumab can effectively treat Hidradenitis Suppurativa (HS) and improve quality of life for patients. Anifrolum

Who is the study for?
This trial is for individuals with Hidradenitis Suppurativa (HS), a chronic skin condition. Participants must pass a screening to confirm they're safe to receive anifrolumab and meet study requirements. Details on specific inclusion or exclusion criteria are not provided.
What is being tested?
The trial tests anifrolumab, a monoclonal antibody designed to block processes involved in HS development. It involves approximately 40 weeks of participation, including screening, treatment every two weeks then monthly for six months, and follow-up.
What are the potential side effects?
Potential side effects are not listed but may include reactions typical of monoclonal antibodies such as infusion reactions, immune system changes, or infections due to the drug's effect on inflammatory processes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have hidradenitis suppurativa in two different body areas.
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I have never had, nor do I currently have Tuberculosis.
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I have 5 or more inflamed skin spots.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on medication for Hidradenitis Suppurativa.
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I have had surgery, not just a minor procedure, in the last 8 weeks or have wounds that are still open.
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I have had a severe case of shingles.
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I have been treated with anifrolumab before.
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I am allergic to a component of the study drug.
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I have active hepatitis.
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I plan to have a major surgery during the study period.
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I was hospitalized or needed IV antibiotics for an infection in the last 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of participants achieving at least a Hidradenitis Suppurativa Clinical Response score of 50 (HiSCR 50) at 12 weeks
Secondary study objectives
Percentage of participants achieving a HiSCR 50 at 24 weeks
Percentage of participants who achieve a HiSCR 75 at 24 weeks of treatment.
Percentage of participants who achieve a Hidradenitis Suppurativa Clinical Response score of 75 (HiSCR 75) at 12 weeks

Side effects data

From 2018 Phase 3 trial • 373 Patients • NCT02446899
23%
Upper respiratory tract infection
16%
Nasopharyngitis
14%
Infusion related reaction
13%
Bronchitis
12%
Urinary tract infection
7%
Herpes zoster
7%
Sinusitis
6%
Cough
6%
Headache
6%
Back pain
6%
Arthralgia
4%
Nausea
2%
Pneumonia
1%
Lip squamous cell carcinoma
1%
Cervical dysplasia
1%
Angioedema
1%
Hypoaesthesia
1%
Acute coronary syndrome
1%
Chilaiditi's syndrome
1%
Hypersensitivity
1%
Appendicitis
1%
Diverticulitis
1%
Gastroenteritis viral
1%
Fall
1%
Nephrolithiasis
1%
Traumatic fracture
1%
Blood creatinine increased
1%
Osteonecrosis
1%
Systemic lupus erythematosus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anifrolumab 300 mg
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AnifrolumabExperimental Treatment1 Intervention
Participants will receive anifrolumab (loading dose of 900mg) intravenously at the first visit, week 4 and week 8. Anifrolumab (maintenance dose of 600mg) will be administered intravenously for weeks 12, 16, and 20.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anifrolumab
2015
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,383 Previous Clinical Trials
289,110,359 Total Patients Enrolled
1 Trials studying Hidradenitis Suppurativa
224 Patients Enrolled for Hidradenitis Suppurativa
University of North Carolina, Chapel HillLead Sponsor
1,552 Previous Clinical Trials
4,268,109 Total Patients Enrolled
2 Trials studying Hidradenitis Suppurativa
106 Patients Enrolled for Hidradenitis Suppurativa
Christopher Sayed, MDPrincipal InvestigatorUNC Dermatology and Skin Cancer Center
~10 spots leftby Jun 2026
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