Back to resultsEfficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MEDI3506
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring MEDI3506, Safety, Efficacy, Atopic Dermatitis, Eczema
Eligibility Criteria
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.
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.
Sites / Locations
- Research Site
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- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
MEDI3506 at dose level 1
MEDI3506 at dose level 2
MEDI3506 at dose level 3
Placebo
Arm Description
Participant will receive multiple doses of MEDI3506 at dose level 1.
Participant will receive multiple doses of MEDI3506 at dose level 2.
Participant will receive multiple doses of MEDI3506 at dose level 3.
Participant will receive multiple doses of Placebo
Outcomes
Primary Outcome Measures
Percent Change From Baseline to Week 16 in EASI Score
The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.
Secondary Outcome Measures
Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 90% reduction from baseline in EASI score.
Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 75% reduction from baseline in EASI score.
Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 50% reduction from baseline in EASI score.
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
The IGA allows investigators to assess overall AD disease severity at 1 given time point and consists of a 5-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease).
Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS
Skin pain (ie, worst skin pain experienced in the previous 24 hours) assessed using an NRS (0 to 10) with 0 = no pain and 10 = worst imaginable pain. The daily assessments were summarised as a weekly mean.
SCORAD: Percent Change From Baseline to Week 16
SCORAD is a clinical tool for assessing the severity of AD that evaluates the extent and intensity of AD lesions, in addition to subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD
Change in percentage of body surface area (BSA) affected by AD from baseline at week 16.
Change From Baseline to Week 16 in DLQI
The Dermatology Life Quality Index (DLQI) is a 10-item, patient- completed, health-related quality of life assessment of dermatology conditions with a recall period of 1 week. Each item is scored on a 4-point Likert scale with 0 = not at all ⁄not relevant, 1 = a little, 2 = a lot, and 3 = very much. The score from each item is summed, and the maximum total score is 30 while the minimum score is 0. Higher score means highest (adverse) effect on participant's life.
Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
The Patient Global Impression of Severity (PGI-S) is a tool that allows patients to rate the severity of a condition over the past 7 days with response options of "No symptoms", "Very mild", "Mild", "Moderate", "Severe" and "Very severe".
Change From Baseline to Week 16 in POEM
The Patient-Oriented Eczema Measure (POEM) is a 7-item questionnaire for assessing disease symptoms including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping occurring in the past week. Each item is scored on a 5-point scale with 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = every day. The total POEM score is calculated by summing the score of each item resulting in a maximum of 28 and a minimum of 0, with higher values indicating severe disease
Change From Baseline to Week 16 in 5-D Itch
The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the pruritus within the last 2 weeks. The scores from each item are summed, with maximum score of 25 and minimum score of 5. Higher score represent worse outcome
Occurrence of Adverse Events
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Oral or Tympanic Temperature Taken During Vital Signs Assessment
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Systolic Blood Pressure Taken During Vital Signs Assessment
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Heart Rate Taken During Vital Signs Assessment
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Respiratory Rate Collected During Vital Signs Assessment
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Heart Rate (Beats/Min) Recorded on ECGs
Collectively with other ECG parameters are used t assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
QT (Miliseconds) Recorded on ECGs
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Left Ventricular Ejection Fraction Measured by Echocardiogram
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Serum MEDI3506 Concentration Profiles
To evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.
Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods
To evaluate the immunogenicity of MEDI3506 in adult subjects with moderate-to-severe AD.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04212169
Brief Title
Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
July 21, 2022 (Actual)
Study Completion Date
September 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
Each participant will be assigned randomly to a treatment arm, which could be different strengths of the active treatment or a placebo which does not contain active treatment. Both Participants and investigators will be masked to the treatment assignment.
Approximately 152 participants will take part in this study. There is a 4 weeks screening period to determine eligibility. After eligibility is confirmed, participants will receive investigational drug or placebo during the 16 weeks treatment period. This is then followed by an 8-week follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
MEDI3506, Safety, Efficacy, Atopic Dermatitis, Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomised to receive MEDI3506 dose 1, MEDI3506 Dose 2 or MEDI3506 dose 3 or placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Investigation product only will be prepared and administered by unmasked personnel. All subjects will receive the same number of injections at each dose.
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI3506 at dose level 1
Arm Type
Experimental
Arm Description
Participant will receive multiple doses of MEDI3506 at dose level 1.
Arm Title
MEDI3506 at dose level 2
Arm Type
Experimental
Arm Description
Participant will receive multiple doses of MEDI3506 at dose level 2.
Arm Title
MEDI3506 at dose level 3
Arm Type
Experimental
Arm Description
Participant will receive multiple doses of MEDI3506 at dose level 3.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participant will receive multiple doses of Placebo
Intervention Type
Drug
Intervention Name(s)
MEDI3506
Intervention Description
multiple doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
multiple doses
Primary Outcome Measure Information:
Title
Percent Change From Baseline to Week 16 in EASI Score
Description
The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16
Description
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 90% reduction from baseline in EASI score.
Time Frame
Week 16
Title
Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16
Description
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 75% reduction from baseline in EASI score.
Time Frame
Week 16
Title
Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16
Description
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 50% reduction from baseline in EASI score.
Time Frame
Week 16
Title
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
Description
The IGA allows investigators to assess overall AD disease severity at 1 given time point and consists of a 5-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease).
Time Frame
Week 16
Title
Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Description
Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.
Time Frame
Week 16
Title
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Description
Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.
Time Frame
Week 16
Title
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS
Description
Skin pain (ie, worst skin pain experienced in the previous 24 hours) assessed using an NRS (0 to 10) with 0 = no pain and 10 = worst imaginable pain. The daily assessments were summarised as a weekly mean.
Time Frame
Week 16
Title
SCORAD: Percent Change From Baseline to Week 16
Description
SCORAD is a clinical tool for assessing the severity of AD that evaluates the extent and intensity of AD lesions, in addition to subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Time Frame
Week 16
Title
Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD
Description
Change in percentage of body surface area (BSA) affected by AD from baseline at week 16.
Time Frame
Week 16
Title
Change From Baseline to Week 16 in DLQI
Description
The Dermatology Life Quality Index (DLQI) is a 10-item, patient- completed, health-related quality of life assessment of dermatology conditions with a recall period of 1 week. Each item is scored on a 4-point Likert scale with 0 = not at all ⁄not relevant, 1 = a little, 2 = a lot, and 3 = very much. The score from each item is summed, and the maximum total score is 30 while the minimum score is 0. Higher score means highest (adverse) effect on participant's life.
Time Frame
Week 16
Title
Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
Description
The Patient Global Impression of Severity (PGI-S) is a tool that allows patients to rate the severity of a condition over the past 7 days with response options of "No symptoms", "Very mild", "Mild", "Moderate", "Severe" and "Very severe".
Time Frame
Week 16
Title
Change From Baseline to Week 16 in POEM
Description
The Patient-Oriented Eczema Measure (POEM) is a 7-item questionnaire for assessing disease symptoms including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping occurring in the past week. Each item is scored on a 5-point scale with 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = every day. The total POEM score is calculated by summing the score of each item resulting in a maximum of 28 and a minimum of 0, with higher values indicating severe disease
Time Frame
Week 16
Title
Change From Baseline to Week 16 in 5-D Itch
Description
The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the pruritus within the last 2 weeks. The scores from each item are summed, with maximum score of 25 and minimum score of 5. Higher score represent worse outcome
Time Frame
Week 16
Title
Occurrence of Adverse Events
Description
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time Frame
up to 24 weeks
Title
Oral or Tympanic Temperature Taken During Vital Signs Assessment
Description
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time Frame
Baseline, week 16 and week 24
Title
Systolic Blood Pressure Taken During Vital Signs Assessment
Description
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time Frame
Baseline, week 16 and week 24
Title
Heart Rate Taken During Vital Signs Assessment
Description
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time Frame
Baseline, week 16 and week 24
Title
Respiratory Rate Collected During Vital Signs Assessment
Description
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time Frame
Baseline, week 16 and week 24
Title
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Description
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time Frame
up to 24 weeks
Title
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Description
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time Frame
up to 24 weeks
Title
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
Description
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time Frame
up to 24 weeks
Title
Heart Rate (Beats/Min) Recorded on ECGs
Description
Collectively with other ECG parameters are used t assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time Frame
Baseline, week 16 and week 24
Title
QT (Miliseconds) Recorded on ECGs
Description
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time Frame
Baseline, week 16 and week 24
Title
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Description
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time Frame
Week 16 and week 24
Title
Left Ventricular Ejection Fraction Measured by Echocardiogram
Description
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Time Frame
Baseline and week 16
Title
Serum MEDI3506 Concentration Profiles
Description
To evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.
Time Frame
Week 16 and week 24
Title
Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods
Description
To evaluate the immunogenicity of MEDI3506 in adult subjects with moderate-to-severe AD.
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Research Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Research Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Research Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Research Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Research Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Research Site
City
Carlton
ZIP/Postal Code
3053
Country
Australia
Facility Name
Research Site
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
Facility Name
Research Site
City
Fremantle
ZIP/Postal Code
6160
Country
Australia
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Research Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Research Site
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-453
Country
Poland
Facility Name
Research Site
City
Kielce
ZIP/Postal Code
25-355
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-681
Country
Poland
Facility Name
Research Site
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-566
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Research Site
City
Alcobendas
ZIP/Postal Code
28100
Country
Spain
Facility Name
Research Site
City
Leganés
ZIP/Postal Code
28915
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41003
Country
Spain
Facility Name
Research Site
City
Corby
ZIP/Postal Code
NN18 9EZ
Country
United Kingdom
Facility Name
Research Site
City
High Wycombe
ZIP/Postal Code
HP11 2QW
Country
United Kingdom
Facility Name
Research Site
City
Kenilworth
ZIP/Postal Code
CV8 1JD
Country
United Kingdom
Facility Name
Research Site
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Research Site
City
Romford
ZIP/Postal Code
RM1 3PJ
Country
United Kingdom
Facility Name
Research Site
City
Shipley
ZIP/Postal Code
BD18 3SA
Country
United Kingdom
Facility Name
Research Site
City
Sidcup
ZIP/Postal Code
DA14 6LT
Country
United Kingdom
Facility Name
Research Site
City
Wokingham
ZIP/Postal Code
RG40 1XS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9182C00001&attachmentIdentifier=48b9bbe6-f0ed-437d-a775-dbb096d8d00a&fileName=d9182c00001-csp-amendment-9_Redacted_For_posting_Final.pdf&versionIdentifier=
Description
Redacted CSP
URL
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Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
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