Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT04212169

Run by

AstraZeneca

People needed

148

Starts

2019-12-09

Expected to finish

2022-09-20

Last updated by the study team

2023-09-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Research Site — Memphis, Tennessee, United States
• Research Site — San Antonio, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Box Hill, Australia
• Research Site — Carlton, Australia
• Research Site — East Melbourne, Australia
• Research Site — Fremantle, Australia
• Research Site — Berlin, Germany
• Research Site — Dresden, Germany
• Research Site — Hamburg, Germany
• Research Site — Mahlow, Germany
• Research Site — Bialystok, Poland
• Research Site — Kielce, Poland
• Research Site — Lodz, Poland
• Research Site — Poznan, Poland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.