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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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2019-003304-12
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Secondary ID [2]
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D9182C00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Change From Baseline to Week 16 in EASI Score
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Assessment method [1]
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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.
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Timepoint [1]
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Week 16
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Secondary outcome [1]
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Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16
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Assessment method [1]
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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.
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Timepoint [1]
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Week 16
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Secondary outcome [2]
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Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16
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Assessment method [2]
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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.
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Timepoint [2]
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Week 16
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Secondary outcome [3]
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Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16
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Assessment method [3]
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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.
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Timepoint [3]
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Week 16
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Secondary outcome [4]
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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
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Assessment method [4]
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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).
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Percentage of Subjects Achieving a Reduction of = 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
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Assessment method [5]
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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.
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Timepoint [5]
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Week 16
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Secondary outcome [6]
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Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
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Assessment method [6]
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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.
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Timepoint [6]
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Week 16
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Secondary outcome [7]
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Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS
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Assessment method [7]
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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.
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Timepoint [7]
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Week 16
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Secondary outcome [8]
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SCORAD: Percent Change From Baseline to Week 16
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Assessment method [8]
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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.
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Timepoint [8]
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Week 16
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Secondary outcome [9]
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Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD
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Assessment method [9]
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Change in percentage of body surface area (BSA) affected by AD from baseline at week 16.
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Timepoint [9]
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Week 16
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Secondary outcome [10]
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Change From Baseline to Week 16 in DLQI
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Assessment method [10]
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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.
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Timepoint [10]
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Week 16
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Secondary outcome [11]
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Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
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Assessment method [11]
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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".
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Timepoint [11]
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Week 16
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Secondary outcome [12]
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Change From Baseline to Week 16 in POEM
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Assessment method [12]
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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
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Timepoint [12]
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Week 16
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Secondary outcome [13]
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Change From Baseline to Week 16 in 5-D Itch
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Assessment method [13]
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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
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Timepoint [13]
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Week 16
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Secondary outcome [14]
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Occurrence of Adverse Events
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Assessment method [14]
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To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
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Timepoint [14]
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up to 24 weeks
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Secondary outcome [15]
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Oral or Tympanic Temperature Taken During Vital Signs Assessment
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Assessment method [15]
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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.
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Timepoint [15]
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Baseline, week 16 and week 24
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Secondary outcome [16]
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Systolic Blood Pressure Taken During Vital Signs Assessment
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Assessment method [16]
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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.
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Timepoint [16]
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Baseline, week 16 and week 24
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Secondary outcome [17]
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Heart Rate Taken During Vital Signs Assessment
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Assessment method [17]
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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.
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Timepoint [17]
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Baseline, week 16 and week 24
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Secondary outcome [18]
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Respiratory Rate Collected During Vital Signs Assessment
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline, week 16 and week 24
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Secondary outcome [19]
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Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
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Assessment method [19]
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To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
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Timepoint [19]
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up to 24 weeks
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Secondary outcome [20]
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Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
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Assessment method [20]
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To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
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Timepoint [20]
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up to 24 weeks
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Secondary outcome [21]
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Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
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Assessment method [21]
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To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
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Timepoint [21]
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up to 24 weeks
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Secondary outcome [22]
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Heart Rate (Beats/Min) Recorded on ECGs
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Assessment method [22]
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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.
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Timepoint [22]
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Baseline, week 16 and week 24
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Secondary outcome [23]
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QT (Miliseconds) Recorded on ECGs
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Assessment method [23]
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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.
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Timepoint [23]
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Baseline, week 16 and week 24
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Secondary outcome [24]
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Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
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Assessment method [24]
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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.
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Timepoint [24]
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Week 16 and week 24
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Secondary outcome [25]
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Left Ventricular Ejection Fraction Measured by Echocardiogram
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Assessment method [25]
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To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
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Timepoint [25]
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Baseline and week 16
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Secondary outcome [26]
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Serum MEDI3506 Concentration Profiles
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Assessment method [26]
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To evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.
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Timepoint [26]
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Week 16 and week 24
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Secondary outcome [27]
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Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods
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Assessment method [27]
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To evaluate the immunogenicity of MEDI3506 in adult subjects with moderate-to-severe AD.
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Timepoint [27]
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up to 24 weeks
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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.
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Minimum age
18
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/12/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/09/2022
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Sample size
Target
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Accrual to date
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Final
148
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Box Hill
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Recruitment hospital [2]
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Research Site - Carlton
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Recruitment hospital [3]
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Research Site - East Melbourne
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Recruitment hospital [4]
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Research Site - Fremantle
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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3053 - Carlton
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Recruitment postcode(s) [3]
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3002 - East Melbourne
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Recruitment postcode(s) [4]
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6160 - Fremantle
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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0
United States of America
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State/province [3]
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Florida
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Country [4]
0
0
United States of America
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State/province [4]
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Louisiana
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Country [5]
0
0
United States of America
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State/province [5]
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North Carolina
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Country [6]
0
0
United States of America
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State/province [6]
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Oklahoma
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Country [7]
0
0
United States of America
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State/province [7]
0
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Rhode Island
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Country [8]
0
0
United States of America
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State/province [8]
0
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South Carolina
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Country [9]
0
0
United States of America
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State/province [9]
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Tennessee
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Country [10]
0
0
United States of America
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State/province [10]
0
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Texas
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Country [11]
0
0
Germany
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State/province [11]
0
0
Berlin
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Country [12]
0
0
Germany
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State/province [12]
0
0
Dresden
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Country [13]
0
0
Germany
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State/province [13]
0
0
Hamburg
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Country [14]
0
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Germany
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State/province [14]
0
0
Mahlow
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Country [15]
0
0
Poland
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State/province [15]
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Bialystok
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Country [16]
0
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Poland
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State/province [16]
0
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Kielce
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Country [17]
0
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Poland
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State/province [17]
0
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Poznan
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Country [18]
0
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Poland
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State/province [18]
0
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Skierniewice
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Country [19]
0
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Poland
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State/province [19]
0
0
Wroclaw
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Country [20]
0
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Poland
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State/province [20]
0
0
Lódz
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Country [21]
0
0
Spain
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State/province [21]
0
0
Alcobendas
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Country [22]
0
0
Spain
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State/province [22]
0
0
Leganés
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Country [23]
0
0
Spain
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State/province [23]
0
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Sevilla
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Country [24]
0
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United Kingdom
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State/province [24]
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Corby
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Country [25]
0
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United Kingdom
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State/province [25]
0
0
High Wycombe
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Country [26]
0
0
United Kingdom
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State/province [26]
0
0
Kenilworth
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Country [27]
0
0
United Kingdom
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State/province [27]
0
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Northwood
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Country [28]
0
0
United Kingdom
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State/province [28]
0
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Romford
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Country [29]
0
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United Kingdom
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State/province [29]
0
0
Shipley
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Country [30]
0
0
United Kingdom
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State/province [30]
0
0
Sidcup
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Country [31]
0
0
United Kingdom
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State/province [31]
0
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Wokingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04212169
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04212169
Download to PDF