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Dermatitis, AtopicPhase 2NCT03563066

Effect of Benralizumab in Atopic Dermatitis

A Phase 2 study testing Benralizumab in people with Dermatitis, Atopic and Dermatitis, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Atopic Dermatitis (AD), also known as eczema, is a common skin disease characterized by itchy lesions. The prevalence of AD has increased over the past few decades, with 15-30% of children and 2-10%of adults being affected. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Dermatitis, Atopic, Dermatitis, Eczema
What is being tested?
Benralizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteCanada
Study dates
4 Sep 2018to 28 Sep 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients 18 through 65 years of age.
  • Women of childbearing potential (WOCBP) must not be actively seeking pregnancy, and must use an effective form of birth control (confirmed by the Investigator). Effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device (IUD)/ levonorgestrel Intrauterine system (IUS), Depo-Provera™ injections, oral contraceptive, and Evra Patch™ or Nuvaring™. WOCBP must agree to use effective method of birth control, as defined above, from enrolment, throughout the study duration and within 16 weeks after last dose of IP. They must demonstrate a negative serum pregnancy test at screening and demonstrate a negative urine pregnancy test immediately before each dose of study drug or placebo. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range.
  • Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
  • All male patients who are sexually active must agree to use an acceptable method of contraception (condom with or without spermicide, vasectomy) from the first dose of investigational product (IP) until 16 weeks after their last dose.
  • General good health
Show all 11Show fewer
  • Moderate to severe atopic dermatitis
  • Able to understand and give written informed consent and has signed a written informed consent form approved by the investigator's Research Ethics Board (REB)
  • The following inclusion criteria must be met for entry into the dosing phase of the study:
  • Positive skin-prick test to common aeroallergens (including cat, dust mite, grass, pollen)
  • Positive late cutaneous response to intradermal allergen challenge

Who cannot join

  • History of anaphylaxis to any biologic therapy or vaccine
  • History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or light headedness, as judged by the investigator
  • Any history or symptoms of cardiovascular disease, particularly coronary artery disease, arrhythmias, hypertension, or congestive heart failure
  • Any history or symptoms of significant neurologic disease, including transient ischemic attack (TIA), stroke, seizure disorder, or behavioral disturbances
  • Any history or symptoms of clinically significant autoimmune disease
  • Any history of clinically significant haematologic abnormality, including coagulopathy or any history of chronic treatment with anticoagulants (e.g. warfarin, etc) or antiplatelet agent (e.g, aspirin, etc)
Show all 35Show fewer
  • Clinically significant abnormalities in laboratory test results at enrolment and during the screening period (including complete blood count, coagulation, chemistry panel and urinalysis) unless judged not significant by the investigator.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.5 times the upper limit of normal (ULN) confirmed during screening period
  • Being pregnant or lactating or have positive serum pregnancy test at enrolment or positive urine pregnancy test during the study
  • Concomitant disease or condition which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study, including, but not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease
  • Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study
  • Presence of skin comorbidities that may interfere with study assessments
  • History of cancer: Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date informed consent. Patients who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date of informed consent.
  • Patient who has a scheduled in-patient surgery or hospitalization during the study.
  • History of Guillain-Barré syndrome
  • A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy
  • Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Patients with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol
  • A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test
  • Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
  • Receipt of any marketed (eg omalizumab) or investigational biologic within 4 months or 5 half-lives prior to randomization is obtained, whichever is longer
  • Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
  • Any allergen immunotherapy within 4 months prior to or throughout the study.
  • Having used any of the following treatments within 4 weeks before the Day -2 baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during study:
  • Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma (IFN-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc.)
  • Phototherapy for AD
  • Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer
  • Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
  • Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit
  • Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. Note: patients may be re-screened after infection resolves
  • Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment
  • Planned or anticipated major surgical procedure during the patient's participation in this study
  • Receipt of live attenuated vaccines 30 days prior to the date of randomization. Receipt of inactive/killed vaccinations (eg, inactive influenza) are allowed provided they are not administered within 1 week before/after any IP administration.
  • Patient is a member of the investigational team or his/her immediate family
  • Pregnant woman
  • Previously received benralizumab (MEDI-563)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McMaster Cardio-Respiratory Research Lab

    Hamilton, Ontario, L8N 3Z5

Other trials in Canada

About this study

Official title: Benralizumab Regulates Atopic Dermatitis Through Effects on Eosinophils, Basophils and Innate Lymphoid Type 2 Cells.

Atopic Dermatitis (AD), also known as eczema, is a common skin disease characterized by itchy lesions. The prevalence of AD has increased over the past few decades, with 15-30% of children and 2-10%of adults being affected. The lesions of AD patients are very inflamed, with an increased number of inflammatory cells in the skin. There are not many medications available that are fully effective and can be used long-term for treatment of atopic dermatitis. Benralizumab is a monoclonal antibody used for treatment of a type of asthma called "eosinophilic asthma". Atopic dermatitis is also associated with elevated levels of eosinophils, and we would like to determine if benralizumab is effective in patients with atopic dermatitis. This is a randomized, double-blind, parallel group, placebo-controlled study will evaluate the effect of 3 doses of a fixed 30 mg dose of benralizumab administered subcutaneously (SC) every 4 weeks to patients with moderate-to-severe atopic dermatitis, on the severity of atopic dermatitis, and the cellular inflammation of skin lesions in these patients. Anti-inflammatory properties of benralizumab when a skin flare is induced in a controlled laboratory setting, in addition to the effects of benralizumab on skin that is already inflamed will be examined.It is hypothesized that benralizumab will attenuate eosinophilic inflammation in the skin.

Read the detailed description

Patients with a history of moderate-to-severe atopic dermatitis will enter a screening period (Days -3 to -1) to assess responses to intradermal allergen challenge. Those developing a late cutaneous response 24 hours post-intradermal allergen challenge will be recruited for the study and have the size of the wheal/flare measured. A punch biopsy obtained from the challenge site and samples of peripheral blood and skin lesions will be obtained. Prior to randomization, skin lesions will be graded using the validated Eczema Area and Severity Index (EASI) Score as a baseline measure of the severity of disease. Patients will then be randomized 1:1 to benralizumab (30 mg SC monthly) or placebo, with dosing at days 0, 28 and 56 (± 3 days). On Day 64 (1 week after the last dose of study drug), an intradermal allergen challenge will be conducted to determine the effect of benralizumab on allergen-induced responses in skin. On Day 65 (24 hours post-intradermal allergen challenge), the size of the wheal/flare will be measured and a punch biopsy will be obtained from the challenge site and samples peripheral blood and skin lesions will be obtained. Skin lesions will be reassessed clinically on Day 65 using the EASI score to assess the effect of benralizumab on changes to the severity of disease. A safety followup visit will take place at week 20, which is 140 days after the first dose (12 weeks after the last dose/11 weeks after the last study procedure).

Primary endpoint

  1. The number of eosinophils per millimetre squared of skin, measured 24 hours post intradermal allergen challenge, 65 days after the first dose. The number of eosinophils in the skin will be assessed by histological examination of a punch skin biopsy obtained from the site of the intradermal allergen challenge. Secondary endpoints
  2. The size of the late cutaneous response, measured 24 hours post intradermal allergen challenge, 65 days after the first dose. The late cutaneous response will be calculated using the length and width of the wheal and flare response to a standardized amount of allergen extract.
Being tested
Benralizumab, Placebo Control
Keywords
Skin Lesions, Benralizumab, Eosinophils, Intra-dermal challenge, Anti-inflammatory agents, Physiological Effects of Drugs
Medical subject headings
Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Skin Diseases, Genetic, Genetic Diseases, Inborn, Skin Diseases, Eczematous, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BenralizumabDrug

    Subcutaneous benralizumab injections once per month for 3 months on Days 0, 28 \& 56.

  • Placebo ControlDrug

    Subcutaneous placebo injections once per month for 3 months on Days 0, 28 \& 56.

Study groups in NCT03563066
Study groupRoleWhat they receive
BenralizumabExperimentalFixed dose 30mg benralizumab.
Receives: Drug: Benralizumab
Placebo ControlPlacebo comparatorWill appear identical in form to benralizumab arm.
Receives: Drug: Placebo Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Allergen-induced Eosinophils in the Skin

    The primary objective is to evaluate the effect of benralizumab on the allergen-induced number of eosinophils in the skin assessed by histological examination compared to placebo. Intradermal saline challenge will be used as a control.

    Measured: Day 65, 24 hours post-intradermal allergen challenge

Secondary outcomes (1)

  1. Allergen-induced Late Phase Cutaneous Response

    To evaluate the effect of Benralizumab on the allergen-induced late phase cutaneous response by measuring the skin wheal compared to placebo.

    Measured: Day 65, at 24 hours post-intradermal allergen challenge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2018
  2. Study start4 Sep 2018
  3. Primary completion28 Sep 2021
  4. Study completion28 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03563066
Sponsor's protocol ID
ESR-16-12430
Status last verified
Oct 2021
First submitted
8 Jun 2018
Last updated
22 Aug 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Whetstone CE, Cusack RP, Price EL, Howie KJ, Stevens C, Al-Sajee D, Beaudin S, Wattie J, Alsaji N, Schlatman A, Luk V, O'Byrne PM, Inman MD, Sehmi R, Lima H, Gauvreau GM. Benralizumab Depletes IL-5Ralpha-Bearing Cells in Skin Lesions of Patients With Atopic Dermatitis. Clin Transl Allergy. 2025 Aug;15(8):e70090. doi: 10.1002/clt2.70090.

    PubMed 40781582

  • Whetstone CE, Cusack RP, Price E, Howie K, Stevens C, Al-Sajee D, Beaudin S, Wattie J, Alsaji N, Schlatman A, Luk V, Ju X, O'Byrne P, Inman M, Sehmi R, Lima H, Gauvreau GM. Effect of benralizumab on inflammation in skin after intradermal allergen challenge in patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol Glob. 2024 Jul 22;3(4):100310. doi: 10.1016/j.jacig.2024.100310. eCollection 2024 Nov.

    PubMed 39234416

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Benralizumab in people with Dermatitis, Atopic and Dermatitis, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Allergen-induced Eosinophils in the Skin (time frame: Day 65, 24 hours post-intradermal allergen challenge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03563066, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

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