Phase 2
N=20
Effect of Benralizumab in Atopic Dermatitis
Dermatitis, Atopic · Dermatitis · Eczema · Skin Diseases · Skin Diseases, Genetic
Bottom Line
View on ClinicalTrials.gov: NCT03563066 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Number of Allergen-induced Eosinophils in the Skin — 11.95; 71.15 cells/mm2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Benralizumab (Drug); Placebo Control (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- McMaster University
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Allergen-induced Eosinophils in the Skin |
11.95; 71.15 | — |
| SECONDARY Allergen-induced Late Phase Cutaneous Response |
18.89; 26.57 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
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
Exclusion Criteria
- 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 pa
Data sourced from ClinicalTrials.gov (NCT03563066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.