Effect of Benralizumab in Atopic Dermatitis

NCT03563066 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ESR-16-12430
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Keywords

Skin Lesions; Benralizumab; Eosinophils; Intra-dermal challenge; Anti-inflammatory agents; Physiological Effects of Drugs

Outcome Measures

Primary Outcomes (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.

  Day 65, 24 hours post-intradermal allergen challenge

Secondary Outcomes (1)

• Allergen-induced Late Phase Cutaneous Response

  Day 65, at 24 hours post-intradermal allergen challenge

Study Arms (2)

Benralizumab

EXPERIMENTAL

Fixed dose 30mg benralizumab.

Drug: Benralizumab

Placebo Control

PLACEBO COMPARATOR

Will appear identical in form to benralizumab arm.

Drug: Placebo Control

Interventions

Benralizumab DRUG

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

Benralizumab

Placebo Control DRUG

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

Placebo Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• Positive skin-prick test to common aeroallergens (including cat, dust mite, grass, pollen)
• Positive late cutaneous response to intradermal allergen challenge

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• McMaster University: lead
• AstraZeneca: collaborator

Study Sites (1)

McMaster Cardio-Respiratory Research Lab

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (2)

• 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.

  PMID: 40781582 DERIVED

• 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.

  PMID: 39234416 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Gail Gauvreau
• Organization: McMaster University

gauvreau@mcmaster.ca

9055259140

Study Officials

• Gail Gauvreau, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 20, 2018
• Study Start: September 4, 2018
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)