Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: MEDI3506

Study type: Interventional

Funder types: Industry

Identifiers

NCT04212169

D9182C00001

2019-003304-12 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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148 participants in 4 patient groups, including a placebo group

MEDI3506 at dose level 1

Experimental group

Description:

Participant will receive multiple doses of MEDI3506 at dose level 1.

Treatment:

Drug: MEDI3506

MEDI3506 at dose level 2

Experimental group

Description:

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

Treatment:

Drug: MEDI3506

MEDI3506 at dose level 3

Experimental group

Description:

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

Treatment:

Drug: MEDI3506

Placebo

Placebo Comparator group

Description:

Participant will receive multiple doses of Placebo

Treatment:

Drug: Placebo