A clinical research study for people with atopic dermatitis

The HILLIER study is being done to learn more about whether a study drug works to improve symptoms for people with moderate to severe atopic dermatitis (AD). The study will also look at how safe the study drug is.

The first treatment period will last 16 weeks. In this period, half of the participants will receive a placebo (a medication that looks like the study drug, but has not active ingredient). In the second treatment period of the study, which will last for 36 weeks, all participants will receive the study drug.

You or someone you care for may be able to take part if you/they:

• Are 12 years of age or older
• Have been diagnosed with moderate to severe AD
• Have symptoms even with using creams or lotions.

If you take part, you will be in the study for up to 1 year and 3 months and have 16 visits to the study centre. The study drug and study assessments will be provided at no cost.

The HILLIER Study

• A Phase 2 Multinational, Randomized, Double-blind, Parallel-group, 16-week Placebo-controlled Study With a 36-Week Extension to Investigate the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis Despite Treatment With Topical Medications
• The aim of this study is to investigate the use of benralizumab as treatment for patients with moderate to severe atopic dermatitis (AD) who remain symptomatic despite treatment with topical medications
• It is proposed that benralizumab will deplete eosinophils from affected skin, improve symptoms of AD, and improve AD-related quality of life
• This study is designed to compare the efficacy of treatment with benralizumab versus placebo and compare benralizumab maintenance dosing regimens in the extension period, and is recruiting male and female participants ≥ 12 years of age.

Information regarding study inclusion and exclusion criteria can be found under the heading ‘Eligibility Criteria’ via the link: Efficacy and Safety Study of the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis – Full Text View – ClinicalTrials.gov

The following study sites are currently recruiting to the Hillier study; please contact them directly for further information:

Site name	Contact name	Website	Telephone	Location
Novatrials	Karen Brennan	www.novatrials.com.au	02 4063 3381	Newcastle NSW
Premier Specialists	Dr Anna Wilson	www.dermatologytrialsaustralia.com.au	02 9598 5800	Kogarah NSW
Royal Melbourne Hospital	Emily Banting	www.thermh.org.au	03 9342 4542	Melbourne VIC
USC Clinical Trials Centre	Catherine Bell	www.usc.edu.au	07 5456 3948	Sunshine Coast QLD
	James Donkin		07 5459 4880
Veracity Clinical Research	Madeleine Supranowicz	www.veracityclinicalresearch.com.au	07 3039 1311	Brisbane QLD