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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04605094




Registration number
NCT04605094
Ethics application status
Date submitted
1/09/2020
Date registered
27/10/2020

Titles & IDs
Public title
Efficacy and Safety Study of the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis
Scientific title
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 HILLIER Study)
Secondary ID [1] 0 0
D3256C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Benralizumab
Treatment: Other - Placebo / Benralizumab

Experimental: Benralizumab -

Experimental: Placebo / Benralizumab -


Treatment: Other: Benralizumab
Benralizumab by subcutaneous injection until Week 16, and then benralizumab by subcutaneous injection during the extension period.

Treatment: Other: Placebo / Benralizumab
Placebo by subcutaneous injection until Week 16, then benralizumab by subcutaneous injection until Week 52.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an Investigator Global Assessment (IGA) 0/1 and a Decrease in IGA of =2 Points at Week 16 Relative to Baseline
Timepoint [1] 0 0
Baseline (Week 0) and at Week 16
Secondary outcome [1] 0 0
Percentage of Participants Who Experienced 75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) at Week 16
Timepoint [1] 0 0
Baseline (Week 0) and at Week 16
Secondary outcome [2] 0 0
Percentage of Participants Who Experienced 90% Reduction From Baseline in Eczema Area and Severity Index (EASI-90) at Week 16
Timepoint [2] 0 0
Baseline (Week 0) and at Week 16
Secondary outcome [3] 0 0
Percentage of Participants With an Improvement of =4 or More Points in Peak Pruritus Weekly Score
Timepoint [3] 0 0
At Week 16

Eligibility
Key inclusion criteria
1. Physician-confirmed diagnosis of AD (according to American Academy of Dermatology Consensus Criteria) that is not adequately controlled with topical medications.
2. EASI score of = 12 at screening and = 16 at randomization.
3. IGA score of = 3 (on a scale of 0 to 4, in which 3 is moderate and 4 is severe) at screening and at randomization.
4. Atopic dermatitis involvement of = 8% body- surface area at screening and = 10% body-surface area at randomization.
5. A pruritus numerical rating scale average score for maximum itch intensity of = 4, based on the average of daily pruritus numerical rating scale scores for maximum itch intensity reported during the 7 days prior to randomization.
6. Documented recent history (within 6 months prior to screening) of inadequate response to treatment with topical medications, or patients for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
7. Participants that have applied a stable dose of topical emollient (moisturizer) twice daily for = 7 consecutive days immediately before the randomization visit. (NOTE: See exclusion criterion 11 for limitations regarding emollients)
8. Participants must be willing and able to complete daily PRO assessments:

* Complete at least 70% of daily PRO assessments between Visit 1 and Visit 2 and
* Complete at least 5 of 7 daily PRO assessments in the 7 days prior to Visit 2.
9. Females of childbearing potential (FOCBP) must agree to use a highly effective method of birth control (confirmed by the Investigator) from randomization, throughout the study duration, and within 16 weeks after last dose of IP and have a negative serum pregnancy test result on Visit 1.
10. Females not of childbearing potential are defined as females who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or who are postmenopausal. Females 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:

1. Females < 50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and with follicle-stimulating hormone (FSH) levels in the postmenopausal range. Until FSH is documented to be within menopausal range, the participant should be treated as a FOCBP.
2. Females = 50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
Minimum age
12 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with active dermatological conditions (eg, psoriasis, seborrheic dermatitis, cutaneous lymphoma) other than atopic dermatitis that, in the investigator's opinion, may interfere with the study assessments
2. Known active allergic or irritant contact dermatitis that, in the investigator's opinion, may interfere with the study assessments
3. Current malignancy, or history of malignancy, with the exception of:

1. Participants 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 participant is in remission and curative therapy was completed at least 12 months prior to the date informed consent, was obtained.
2. Participants who have had other malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to the date informed consent, was obtained.
4. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:

1. Affect the safety of the participant throughout the study
2. Influence the findings of the studies or their interpretations
3. Impede the participant's ability to complete the entire duration of study.
5. History of anaphylaxis to any biologic therapy or vaccine
6. 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
7. Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening/run-in period which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete entire duration of the study
8. Current active liver disease:

1. Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen [HBsAg] or hepatitis C antibody), or other stable chronic liver disease are acceptable if participant otherwise meets eligibility criteria. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis.
2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level = 3 times the upper limit of normal (ULN), confirmed by repeated testing during the run-in period. Transient increase of AST/ALT level that resolves by the time of randomization is acceptable if in the Investigator's opinion the participant does not have an active liver disease and meets other eligibility criteria.
9. A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test Prior/concomitant Therapy
10. Participants who have received treatment for AD with TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase-4 (PDE4) inhibitors within the 7 days prior to the randomization visit
11. 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)
12. Regular use (2 visits per week) of a tanning booth/parlor or phototherapy for AD within 4 weeks prior to the randomization visit
13. Use of immunosuppressive medication including, but not limited to: methotrexate, cyclosporine, azathioprine, systemic corticosteroids within 4 weeks or 5 half-lives prior to the date informed consent is obtained, whichever is longer.

Other
14. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
15. Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to the date informed consent is obtained, whichever is longer
16. Receipt of live attenuated vaccines 30 days prior to first dose of IP
17. Receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to the date informed consent is obtained, whichever is longer
18. Previously received benralizumab (MEDI-563, FASENRA)
19. Change to allergen immunotherapy or new allergen immunotherapy within 30 days prior to the date of informed consent and anticipated changes in immunotherapy throughout the study
20. Planned elective major surgical procedures during the conduct of the study
21. Previous randomization in the present study
22. Concurrent enrollment in another clinical trial
23. AstraZeneca staff involved in the planning and/or conduct of the study
24. For females only: Currently pregnant, breastfeeding, or lactating females A serum pregnancy test will be done for FOCBP at Visit 1 and a urine pregnancy test must be performed for FOCBP at each subsequent treatment visit prior to IP administration. A positive urine test result must be confirmed with a serum pregnancy test. If serum test is positive, the participant should be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/09/2022
Sample size
Target
Accrual to date
Final
194
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Kogarah
Recruitment hospital [2] 0 0
Research Site - Parkville
Recruitment hospital [3] 0 0
Research Site - Sippy Downs
Recruitment hospital [4] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment postcode(s) [3] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [4] 0 0
04102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Hampshire
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Haskovo
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Pleven
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Sofia
Country [13] 0 0
Czechia
State/province [13] 0 0
Brno
Country [14] 0 0
Czechia
State/province [14] 0 0
Ostrava-Poruba
Country [15] 0 0
Czechia
State/province [15] 0 0
Ostrava
Country [16] 0 0
Czechia
State/province [16] 0 0
Pardubice
Country [17] 0 0
Czechia
State/province [17] 0 0
Praha 10
Country [18] 0 0
Czechia
State/province [18] 0 0
Praha
Country [19] 0 0
France
State/province [19] 0 0
Brest Cedex 2
Country [20] 0 0
France
State/province [20] 0 0
Lille Cedex
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Ansan-si
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Daegu
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Gwangju
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seongnam-si
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Seoul
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Yangsan-si
Country [27] 0 0
Poland
State/province [27] 0 0
Krakow
Country [28] 0 0
Poland
State/province [28] 0 0
Lodz
Country [29] 0 0
Poland
State/province [29] 0 0
Osielsko
Country [30] 0 0
Poland
State/province [30] 0 0
Poznan
Country [31] 0 0
Poland
State/province [31] 0 0
Warszawa
Country [32] 0 0
Spain
State/province [32] 0 0
Alicante
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Cordoba
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Spain
State/province [36] 0 0
Manises

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Iqvia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Emma Guttman, MD, PhD
Address 0 0
MOUNT SINAI HOSPITAL
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04605094