Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis

AstraZeneca148 enrolled

Overview

This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

148

Conditions

Atopic Dermatitis

Interventions

MEDI3506DRUG

multiple doses

PlaceboDRUG

multiple doses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (38)

Outcomes

Primary Outcomes

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.

Time frame: Week 16

Secondary Outcomes

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.

Time frame: Week 16

Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16

Time frame: Week 16

Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16

Time frame: Week 16

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).

Data from ClinicalTrials.gov

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Research Site

Birmingham, Alabama, United States

Research Site

Santa Monica, California, United States

Research Site

Jacksonville, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Baton Rouge, Louisiana, United States

Research Site

Charlotte, North Carolina, United States

Research Site

Tulsa, Oklahoma, United States

Research Site

Providence, Rhode Island, United States

Research Site

Spartanburg, South Carolina, United States

...and 28 more locations

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.

Time frame: Week 16

Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS

Time frame: Week 16

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.

Time frame: Week 16

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.

Time frame: Week 16

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.

Time frame: 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.

Time frame: Week 16

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".

Time frame: Week 16

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

Time frame: Week 16

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

Time frame: Week 16

Occurrence of Adverse Events

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

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.

Time frame: Baseline, week 16 and week 24

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.

Time frame: Baseline, week 16 and week 24

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.

Time frame: Baseline, week 16 and week 24

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.

Time frame: Baseline, week 16 and week 24

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.

Time frame: up to 24 weeks

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.

Time frame: up to 24 weeks

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.

Time frame: up to 24 weeks

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.

Time frame: Baseline, week 16 and week 24

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.

Time frame: Baseline, week 16 and week 24

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.

Time frame: Week 16 and week 24

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.

Time frame: Baseline and week 16

Serum MEDI3506 Concentration Profiles

To evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.

Time frame: Week 16 and week 24

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.

Time frame: up to 24 weeks