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Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04212169
Recruitment Status : Active, not recruiting
First Posted : December 26, 2019
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: MEDI3506 Drug: Placebo Phase 2

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 3 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomised to receive MEDI3506 dose 1, MEDI3506 Dose 2 or MEDI3506 dose 3 or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
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
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : August 12, 2021
Estimated Study Completion Date : August 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: MEDI3506 at dose level 1
Participant will receive multiple doses of MEDI3506 at dose level 1.
Drug: MEDI3506
multiple doses

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

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

Placebo Comparator: Placebo
Participant will receive multiple doses of Placebo
Drug: Placebo
multiple doses




Primary Outcome Measures :
  1. The severity of the signs of eczema and the extent affected as graded by Eczema Area and Severity Index, including change from baseline [ Time Frame: Week 16 ]
    To assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD.


Secondary Outcome Measures :
  1. The severity of the signs of eczema and the extent affected as graded by Eczema Area and Severity Index, including change from baseline [ Time Frame: Week 8 and Week 16 ]
    To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD.

  2. Disease severity assessed by examination from Investigator's Global Assessment [ 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.

  3. Itch rating by patient from Peak Pruritis Numerical Rating Scale [ 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.

  4. Skin pain rating by patient from Skin Pain Numerical Rating Scale [ 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.

  5. Severity of signs and symptoms as graded by SCORing Atopic Dermatitis [ 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.

  6. Percentage of Body Surface Area affected by AD [ 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.

  7. Measurement of patient's skin problem and how it affected their life by Dermatology Life Quality Index [ 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.

  8. Patient description of Atopic Dermatitis or eczema from Patient Global Impression of Severity [ 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.

  9. Eczema condition declared by patient from Patient-Orientated Eczema Measure [ 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.

  10. Measurement of duration, degree, direction, disability and distribution attributed to itching from 5-D Pruritus Scale [ 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.

    5-D Pruritis Scale is an accepted composite score and reporting method which looks at 5 domains (Duration, Degree, Direction, Disability and Distribution) which are then summed together to provide a total 5-D score. The 5-D score range from 5 (no pruritus) to 25 (most severe Pruritus).


  11. Incidence and severity 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.

  12. Oral or tympanic temperature taken during vital signs assessment [ Time Frame: up to 24 weeks ]
    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.

  13. Blood pressure taken during vital signs assessment [ Time Frame: up to 24 weeks ]
    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.

  14. Heart rate taken during vital signs assessment [ Time Frame: up to 24 weeks ]
    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.

  15. Respiratory rate collected during vital signs assessment [ Time Frame: up to 24 weeks ]
    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. Frequencies of abnormal laboratory assessments relative to the 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.

  17. Frequencies of abnormal laboratory assessments relative to the 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.

  18. Frequencies of abnormal laboratory assessments relative to the 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.

  19. Heart rate (beats/min) recorded on ECGs [ Time Frame: up to 24 weeks ]
    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.

  20. QT (ms) recorded on ECGs [ Time Frame: up to 24 weeks ]
    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.

  21. Presence of sinus rhythm as recorded on ECGs [ Time Frame: up to 24 weeks ]
    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.

  22. Frequencies of Investigator's overall ECGs evaluations, e.g. normal/abnormal and their clinical significance [ Time Frame: up to 24 weeks ]
    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.

  23. Left Ventricular Ejection Fraction measured by Echocardiogram [ 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.

  24. Terminal half-life of MEDI3506 [ Time Frame: Up to 24 weeks ]
    Collectively with maximum concentration of MEDI3506 are used to evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.

  25. Maximum concentration of MEDI3506 [ Time Frame: Up to 24 weeks ]
    Collectively with terminal half-life are used to evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.

  26. Incidence of Anti-drug antibody [ Time Frame: Up to 24 weeks ]
    To evaluate the immunogenicity of MEDI3506 in adult subjects with moderate-to-severe AD.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 75 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 ≥ 16.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04212169


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States, 35209
United States, California
Research Site
Santa Monica, California, United States, 90404
United States, Florida
Research Site
Aventura, Florida, United States, 33180
Research Site
Jacksonville, Florida, United States, 32256
Research Site
Orlando, Florida, United States, 32806
United States, Louisiana
Research Site
Baton Rouge, Louisiana, United States, 70808
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States, 55402
United States, Oklahoma
Research Site
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Research Site
Memphis, Tennessee, United States, 38119
United States, Texas
Research Site
Hurst, Texas, United States, 76054
Research Site
San Antonio, Texas, United States, 78213
Research Site
San Antonio, Texas, United States, 78229
Australia
Research Site
Box Hill, Australia, 3128
Research Site
Carlton, Australia, 3053
Research Site
East Melbourne, Australia, 3002
Research Site
Fremantle, Australia, 6160
Research Site
Woolloongabba, Australia, 04102
Germany
Research Site
Berlin, Germany, 10117
Research Site
Frankfurt/Main, Germany, 60590
Research Site
Hamburg, Germany, 20246
Research Site
Kiel, Germany, 24105
Research Site
Lübeck, Germany, 23538
Research Site
Mahlow, Germany, 15831
Poland
Research Site
Bialystok, Poland, 15-453
Research Site
Kielce, Poland, 25-355
Research Site
Krakow, Poland, 30-363
Research Site
Skierniewice, Poland, 96-100
Research Site
Sochaczew, Poland, 96-500
Research Site
Wroclaw, Poland, 50-566
Research Site
Łódź, Poland, 90-436
United Kingdom
Research Site
Corby, United Kingdom, NN18 9EZ
Research Site
Kenilworth, United Kingdom, CV8 1JD
Research Site
Northwood, United Kingdom, HA6 2RN
Research Site
Romford, United Kingdom, RM1 3PJ
Research Site
Shipley, United Kingdom, BD18 3SA
Research Site
Sidcup, United Kingdom, DA14 6LT
Research Site
Wokingham, United Kingdom, RG40 1XS
Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04212169    
Other Study ID Numbers: D9182C00001
2019-003304-12 ( EudraCT Number )
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
MEDI3506
Safety
Efficacy
Atopic Dermatitis
Eczema
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases