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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03809663




Registration number
NCT03809663
Ethics application status
Date submitted
10/01/2019
Date registered
18/01/2019
Date last updated
22/08/2019

Titles & IDs
Public title
A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis
Scientific title
A Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tezepelumab Alone or Combined With Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis
Secondary ID [1] 0 0
2018-001997-52
Secondary ID [2] 0 0
20170755
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: Drugs - Tezepelumab
Other interventions - Placebo

Experimental: Tezepelumab high dose - subcutaneous injection every 2 weeks

Experimental: Tezepelumab low dose - subcutaneous injection every 4 weeks

Experimental: Tezepelumab medium dose - subcutaneous injection every 2 weeks

Placebo Comparator: Placebo - subcutaneous injection every 2 weeks or every 4 weeks


Treatment: Drugs: Tezepelumab
Solution for injection

Other interventions: Placebo
Placebo solution for injection

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) (IGA 0/1) and 75% reduction of EASI at Week 16 - Evaluate the effect of tezepelumab compared with placebo, assessed using the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI)
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
50% and 90% reduction in EASI - Estimate the effect of tezepelumab compared with placebo on the efficacy measure of EASI
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Time at which EASI 50/75/90 is achieved from day 1 - Estimate the time needed to reach EASI 50/75/90
Timepoint [2] 0 0
Day 1
Secondary outcome [3] 0 0
SCORAD (Scoring Atopic Dermatitis) at week 16 - Estimate the effect of tezepelumab compared with placebo on the efficacy measure of Scoring Atopic Dermatitis (SCORAD). The scale is used to assess the severity (extent, intensity) of Atopic Dermatitis including lesions and subjective symptoms. The minimum score is 0 (zero) and maximum score is 103. Therefore, the scale represented would be 0-103 with higher values indicating more severe disease.
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Pruritus NRS (Numerical Rating Scale) at week 16 - Estimate the effect of tezepelumab compared with placebo on the patient-reported outcome (PRO) measure of pruritus assessed using an numeric rating scale (NRS). Scale is 0 (zero) to 10, where 0 represents no itch and 10 represents worst imaginable itch.
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Serum trough concentrations of tezepelumab at scheduled visits - Characterize the pharmacokinetics (PK) of tezepelumab
Timepoint [5] 0 0
Up to week 70

Eligibility
Key inclusion criteria
- Subject has provided informed consent prior to initiation of any study specific
activities/procedures.

- Age greater than or equal to 18 to less than or equal to 75 years at screening.

- Clinical diagnosis of chronic AD (also known as atopic eczema) for at least 2 years
prior to screening and has confirmed AD (Hanifin and Rajka criteria for AD (Hanifin
and Rajka, 1980).

- AD that affects greater than or equal to' 10% body surface area as assessed by EASI at
screening and on day 1.

- An IGA score of greater than or equal to 3 at screening and on day 1.

- An EASI score of greater than or equal to 16 at screening and on day 1.

- Subject discontinued treatment with TCS, topical calcineurin inhibitors (TCI),
prescription moisturizers, or moisturizers containing additives such as ceramide,
hyaluronic acid, urea, or filaggrin for at least the 7 days immediately prior to the
first dose of investigational product.

- Documented recent history (within 12 months before the screening visit) of inadequate
response totreatment with topical TCS or subjects for whom topical treatments are
otherwise medically inadvisable (ie, because of important side effects or safety
risks).

- Inadequate response is defined as failure to achieve and maintain remission or a low
disease activity state (comparable to IGA 0 = clear to IGA 2 = mild) despite treatment
with a daily regimen of TCS of medium or higher potency (with or without TCI as
appropriate).
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active dermatologic conditions, which might confound the diagnosis of AD or would
interfere with the assessment of treatment, such as scabies, seborrheic dermatitis,
cutaneous lymphoma, ichthyosis, psoriasis, allergic contact dermatitis, or irritant
contact dermatitis.

- History of a clinically significant infection within 28 days prior to day 1 that, in
the opinion of the investigator or medical monitor, might compromise the safety of the
subject in the study, interfere with evaluation of the investigational product, or
reduce the subject's ability to participate in the study. Clinically significant
infections are defined as either of the following: 1) a systemic infection; or 2) a
serious skin infection requiring parenteral antibiotic, antiviral, or antifungal
medication.

- Diagnosis of a helminth parasitic infection within 6 months prior to screening that
had not been treated with or had failed to respond to standard of care therapy.

- Documented medical history of chronic alcohol or drug abuse within 12 months prior to
screening.

- History of anaphylaxis following any biologic therapy.

- Evidence of active liver disease at screening, including jaundice or aspartate
aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase
greater than twice the upper limit of normal (ULN).

- Diagnosis and/or treatment of tuberculosis within the 12 months prior to screening.

- Positive hepatitis B surface antigen or hepatitis C antibody serology. Subjects with a
history of hepatitis B vaccination without a history of hepatitis B are allowed to
enroll in the study.

- Positive human immunodeficiency virus (HIV) test at screening or the subject is taking
antiretroviral medications, as determined by medical history, prior medications,
and/or the subject's verbal report.

- Other Medical Conditions>

- History of malignancy, except for basal cell carcinoma or in situ carcinoma of the
cervix treated with apparent success with curative therapy = 12 months prior to
screening or other malignancies treated with apparent success with curative therapy =
5 years prior to screening.

- History or evidence of severe depression, schizophrenia, previous suicide attempts, or
suicidal ideation.

Prior/Concomitant Therapy:

- Subjects who are unwilling to abstain from the use of TCS, TCI, prescription
moisturizers, or moisturizers containing additives such as ceramide, hyaluronic acid,
urea, or filaggrin from screening through week 16 (applies only to Part A subjects)

- Subjects who have had side effects of topical medications including intolerance to
treatment, hypersensitivity reactions, significant skin atrophy, or systemic effects
as assessed by the investigator or by the subject's treating physician (applies only
to Part B subjects)

- More than or equal to 30% of the total lesional surface is located on areas of thin
skin that cannot be safely treated with medium or higher potency TCS (eg, face, neck,
intertriginous areas, areas of skin atrophy) (applies only to Part B subjects)

- Receipt of any approved biologic agent (eg, dupilumab) within 4 months prior to
screening

- Have used immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids,
cyclosporine, mycophenolate-mofetil, interferon (IFN)-gamma, Janus kinase inhibitors,
azathioprine, methotrexate) within 4 weeks prior to screening, or any condition that,
in the opinion of the investigator, is likely to require such treatment(s) during the
first 4 weeks of study treatment.

- Have had phototherapy for AD in the 2 months prior to day 1, and subjects unwilling to
avoid phototherapy during the first 16 weeks of the study

- If on allergen-specific immunotherapy, subjects must be on a maintenance dose and
schedule for = 28 days prior to screening. Allergen-specific immunotherapy is defined
as SC immunotherapy to aeroallergens and/o venom (Hymenoptera) as well as sublingual
immunotherapy to aeroallergens

- Vaccination with a live or attenuated vaccine within 28 days prior to day 1. Receipt
of inactive/killed vaccinations (eg, inactive influenza) is allowed, provided the
vaccinations are not administered within 7 days before or after any study visit. Note
that receipt of the Th2 cytokine inhibitor suplatast within 15 days prior to screening
is allowed.

- Major surgery within 8 weeks prior to screening or planned inpatient surgery or
hospitalization during the study period

- Currently receiving treatment in another investigational device or drug study, or less
than 6 months since ending treatment on another investigational device or drug
study(ies). Other investigational procedures while participating in this study are
excluded.

Other Exclusions:

- Female subject is pregnant or breastfeeding or planning to become pregnant or
breastfeed during treatment and for an additional 14 weeks after the last dose of
investigational product. (Females of childbearing potential should only be enrolled in
the study after a negative highly sensitive serum pregnancy test).

- Female subjects of childbearing potential who are sexually active with unsterilized
male partners unwilling to use 1 highly effective method of contraception during
treatment and for an additional 14 weeks after the last dose of investigational
product. Cessation of contraception after this point must be discussed with a
responsible physician. Females of childbearing potential are defined as those who are
not surgically sterile (ie, had bilateral tubal ligation, bilateral oophorectomy, or
complete hysterectomy) or postmenopausal (defined as 12 months with no menses without
an alternative medical cause). A highly effective method of contraception is defined
as one that resulted in a low failure rate (ie, < 1% per year) when used consistently
and correctly. Refer to Appendix 5 for additional contraceptive information.

- Male subjects with a female partner of childbearing potential who are unwilling to
practice sexual abstinence (refrain from heterosexual intercourse) or use
contraception during treatment and for an additional 14 weeks after the last dose of
investigational product. Refer to Appendix 5 for additional contraceptive information.

- Male subjects with a pregnant partner who are unwilling to practice abstinence or use
a condom during treatment and for an additional 14 weeks after the last dose of
investigational product.

- Male subjects unwilling to abstain from donating sperm during treatment and for an
additional 14 weeks after the last dose of investigational product.

- Subject has known sensitivity to any of the products or components to be administered
during dosing.

- History or evidence of any other clinically significant disorder, condition or disease
(with the exception of those outlined above) that, in the opinion of the investigator
or Amgen physician, if consulted, would pose a risk to subject safety or interfere
with the study evaluation, procedures, or completion.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Sydney
Recruitment hospital [2] 0 0
Research Site - Woolloongabba
Recruitment hospital [3] 0 0
Research Site - Carlton
Recruitment hospital [4] 0 0
Research Site - Parkville
Recruitment hospital [5] 0 0
Research Site - Fremantle
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
6160 - Fremantle
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
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Czechia
State/province [15] 0 0
Brno
Country [16] 0 0
Czechia
State/province [16] 0 0
Novy Jicin
Country [17] 0 0
Czechia
State/province [17] 0 0
Ostrava-Poruba
Country [18] 0 0
Czechia
State/province [18] 0 0
Praha 1
Country [19] 0 0
Czechia
State/province [19] 0 0
Praha 8
Country [20] 0 0
Estonia
State/province [20] 0 0
Tallinn
Country [21] 0 0
Estonia
State/province [21] 0 0
Tartu
Country [22] 0 0
Germany
State/province [22] 0 0
Göttingen
Country [23] 0 0
Hungary
State/province [23] 0 0
Budapest
Country [24] 0 0
Hungary
State/province [24] 0 0
Debrecen
Country [25] 0 0
Hungary
State/province [25] 0 0
Miskolc
Country [26] 0 0
Hungary
State/province [26] 0 0
Pecs
Country [27] 0 0
Hungary
State/province [27] 0 0
Szeged
Country [28] 0 0
Japan
State/province [28] 0 0
Chiba
Country [29] 0 0
Japan
State/province [29] 0 0
Fukuoka
Country [30] 0 0
Japan
State/province [30] 0 0
Hokkaido
Country [31] 0 0
Japan
State/province [31] 0 0
Osaka
Country [32] 0 0
Japan
State/province [32] 0 0
Tokyo
Country [33] 0 0
Japan
State/province [33] 0 0
Toyama
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Bucheon-si, Gyeonggi-do
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Busan
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seoul
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Suwon-si, Gyeonggi-do
Country [38] 0 0
Latvia
State/province [38] 0 0
Riga
Country [39] 0 0
Latvia
State/province [39] 0 0
Ventspils
Country [40] 0 0
Poland
State/province [40] 0 0
Gdansk
Country [41] 0 0
Poland
State/province [41] 0 0
Lodz
Country [42] 0 0
Poland
State/province [42] 0 0
Lublin
Country [43] 0 0
Poland
State/province [43] 0 0
Swidnik
Country [44] 0 0
Poland
State/province [44] 0 0
Warszawa
Country [45] 0 0
Poland
State/province [45] 0 0
Wroclaw
Country [46] 0 0
Spain
State/province [46] 0 0
Andalucía
Country [47] 0 0
Spain
State/province [47] 0 0
Cataluña
Country [48] 0 0
Spain
State/province [48] 0 0
Comunidad Valenciana
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
Ukraine
State/province [50] 0 0
Chernivtsi
Country [51] 0 0
Ukraine
State/province [51] 0 0
Kyiv
Country [52] 0 0
Ukraine
State/province [52] 0 0
Uzhhorod
Country [53] 0 0
Ukraine
State/province [53] 0 0
Zaporizhzhia
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Dundee
Country [55] 0 0
United Kingdom
State/province [55] 0 0
London
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This phase 2b study is designed to evaluate the safety and efficacy of tezepelumab as a
monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe
AD.
Trial website
https://clinicaltrials.gov/show/NCT03809663
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03809663