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NCT Number: NCT04212169

Efficacy and Safety of MEDI3506 in 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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Box Hill, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MEDI3506

Drug

multiple doses

Placebo

Drug

multiple doses

Primary outcomes

  1. Percent Change From Baseline to Week 16 in EASI Score

    Time frame: Week 16

    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 outcomes

  1. Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. 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

    Time frame: 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).

  5. Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS

    Time frame: Week 16

    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.

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

    Time frame: Week 16

    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.

  7. Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS

    Time frame: Week 16

    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.

  8. SCORAD: Percent Change From Baseline to Week 16

    Time frame: 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.

  9. Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD

    Time frame: Week 16

    Change in percentage of body surface area (BSA) affected by AD from baseline at week 16.

  10. Change From Baseline to Week 16 in DLQI

    Time frame: Week 16

    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.

  11. Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16

    Time frame: 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".

  12. Change From Baseline to Week 16 in POEM

    Time frame: Week 16

    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

  13. Change From Baseline to Week 16 in 5-D Itch

    Time frame: Week 16

    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

  14. Occurrence of Adverse Events

    Time frame: up to 24 weeks

    To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.

  15. Oral or Tympanic Temperature Taken During Vital Signs Assessment

    Time frame: Baseline, week 16 and week 24

    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.

  16. Systolic Blood Pressure Taken During Vital Signs Assessment

    Time frame: Baseline, week 16 and week 24

    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.

  17. Heart Rate Taken During Vital Signs Assessment

    Time frame: Baseline, week 16 and week 24

    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.

  18. Respiratory Rate Collected During Vital Signs Assessment

    Time frame: Baseline, week 16 and week 24

    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.

  19. Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology

    Time frame: up to 24 weeks

    To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.

  20. Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry

    Time frame: up to 24 weeks

    To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.

  21. Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis

    Time frame: up to 24 weeks

    To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.

  22. Heart Rate (Beats/Min) Recorded on ECGs

    Time frame: Baseline, week 16 and week 24

    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.

  23. QT (Miliseconds) Recorded on ECGs

    Time frame: Baseline, week 16 and week 24

    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.

  24. Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance

    Time frame: Week 16 and week 24

    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.

  25. Left Ventricular Ejection Fraction Measured by Echocardiogram

    Time frame: Baseline and week 16

    To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.

  26. Serum MEDI3506 Concentration Profiles

    Time frame: Week 16 and week 24

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

  27. Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods

    Time frame: up to 24 weeks

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 26, 2019
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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