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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

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

Herpes zoster

Sinusitis

Cough

Headache

Back pain

Arthralgia

Nausea

Pneumonia

Lip squamous cell carcinoma

Cervical dysplasia

Angioedema

Hypoaesthesia

Acute coronary syndrome

Chilaiditi's syndrome

Hypersensitivity

Appendicitis

Diverticulitis

Gastroenteritis viral

Fall

Nephrolithiasis

Traumatic fracture

Blood creatinine increased

Osteonecrosis

Systemic lupus erythematosus

100%

80%

60%

40%

20%

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

0 / 12Eligibility criteria met