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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04212169




Registration number
NCT04212169
Ethics application status
Date submitted
4/11/2019
Date registered
26/12/2019
Date last updated
28/09/2023

Titles & IDs
Public title
Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Scientific title
A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects With Moderate-to-severe Atopic Dermatitis
Secondary ID [1] 0 0
2019-003304-12
Secondary ID [2] 0 0
D9182C00001
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 - MEDI3506
Treatment: Drugs - Placebo

Experimental: MEDI3506 at dose level 1 - Participant will receive multiple doses of MEDI3506 at dose level 1.

Experimental: MEDI3506 at dose level 2 - Participant will receive multiple doses of MEDI3506 at dose level 2.

Experimental: MEDI3506 at dose level 3 - Participant will receive multiple doses of MEDI3506 at dose level 3.

Placebo comparator: Placebo - Participant will receive multiple doses of Placebo


Treatment: Drugs: MEDI3506
multiple doses

Treatment: Drugs: Placebo
multiple doses
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline to Week 16 in EASI Score
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Percentage of Subjects Achieving a Reduction of = 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
SCORAD: Percent Change From Baseline to Week 16
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Change From Baseline to Week 16 in DLQI
Timepoint [10] 0 0
Week 16
Secondary outcome [11] 0 0
Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
Timepoint [11] 0 0
Week 16
Secondary outcome [12] 0 0
Change From Baseline to Week 16 in POEM
Timepoint [12] 0 0
Week 16
Secondary outcome [13] 0 0
Change From Baseline to Week 16 in 5-D Itch
Timepoint [13] 0 0
Week 16
Secondary outcome [14] 0 0
Occurrence of Adverse Events
Timepoint [14] 0 0
up to 24 weeks
Secondary outcome [15] 0 0
Oral or Tympanic Temperature Taken During Vital Signs Assessment
Timepoint [15] 0 0
Baseline, week 16 and week 24
Secondary outcome [16] 0 0
Systolic Blood Pressure Taken During Vital Signs Assessment
Timepoint [16] 0 0
Baseline, week 16 and week 24
Secondary outcome [17] 0 0
Heart Rate Taken During Vital Signs Assessment
Timepoint [17] 0 0
Baseline, week 16 and week 24
Secondary outcome [18] 0 0
Respiratory Rate Collected During Vital Signs Assessment
Timepoint [18] 0 0
Baseline, week 16 and week 24
Secondary outcome [19] 0 0
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Timepoint [19] 0 0
up to 24 weeks
Secondary outcome [20] 0 0
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Timepoint [20] 0 0
up to 24 weeks
Secondary outcome [21] 0 0
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
Timepoint [21] 0 0
up to 24 weeks
Secondary outcome [22] 0 0
Heart Rate (Beats/Min) Recorded on ECGs
Timepoint [22] 0 0
Baseline, week 16 and week 24
Secondary outcome [23] 0 0
QT (Miliseconds) Recorded on ECGs
Timepoint [23] 0 0
Baseline, week 16 and week 24
Secondary outcome [24] 0 0
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Timepoint [24] 0 0
Week 16 and week 24
Secondary outcome [25] 0 0
Left Ventricular Ejection Fraction Measured by Echocardiogram
Timepoint [25] 0 0
Baseline and week 16
Secondary outcome [26] 0 0
Serum MEDI3506 Concentration Profiles
Timepoint [26] 0 0
Week 16 and week 24
Secondary outcome [27] 0 0
Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods
Timepoint [27] 0 0
up to 24 weeks

Eligibility
Key inclusion criteria
* Age 18 to 65 years inclusive at the time of consent.
* Body mass index between 19.0 and 40.0 kg/m2 inclusive.
* Documented history of chronic AD, for at least 1 year prior to screening Visit 1.
* Meets at minimum 1 of the criteria, as follows:

* History of inadequate response to topical medications for AD
* Subject intolerance to treatment with topical medications for AD, or
* Topical medications are otherwise medically inadvisable
* AD that affects = 10% of the body surface area (BSA).
* An EASI score of = 12 at Visit 1 and = 16 at Visit 3 (Day 1).
* An IGA score of = 3.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
* Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram [ECG]) or from safety laboratory analysis.
* Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin.
* Known active allergic or irritant contact dermatitis.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/09/2022
Sample size
Target
Accrual to date
Final
148
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Carlton
Recruitment hospital [3] 0 0
Research Site - East Melbourne
Recruitment hospital [4] 0 0
Research Site - Fremantle
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Rhode Island
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Dresden
Country [13] 0 0
Germany
State/province [13] 0 0
Hamburg
Country [14] 0 0
Germany
State/province [14] 0 0
Mahlow
Country [15] 0 0
Poland
State/province [15] 0 0
Bialystok
Country [16] 0 0
Poland
State/province [16] 0 0
Kielce
Country [17] 0 0
Poland
State/province [17] 0 0
Poznan
Country [18] 0 0
Poland
State/province [18] 0 0
Skierniewice
Country [19] 0 0
Poland
State/province [19] 0 0
Wroclaw
Country [20] 0 0
Poland
State/province [20] 0 0
Lódz
Country [21] 0 0
Spain
State/province [21] 0 0
Alcobendas
Country [22] 0 0
Spain
State/province [22] 0 0
Leganés
Country [23] 0 0
Spain
State/province [23] 0 0
Sevilla
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Corby
Country [25] 0 0
United Kingdom
State/province [25] 0 0
High Wycombe
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Kenilworth
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Northwood
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Romford
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Shipley
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Sidcup
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Wokingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
Trial website
https://clinicaltrials.gov/study/NCT04212169
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04212169