OHSU

IRB #

IRB00009215

Title

A randomized, placebo-controlled multiple-rising dose study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenecity of intravenous MK-8226 in adults with atopic dermatitis

Principal Investigator

Jon Hanifin

Study Purpose

To test the safety and tolerability of the study drug in adults with moderate to severe atopic dermatitis (also called eczema, a chronic and/or recurring itchy skin condition).

Medical Condition(s)

Moderate to severe atopic dermatitis (also called eczema, a chronic and/or recurring itchy skin condition).

Eligibility Criteria

18 years of age or older (no upper age limit)
Moderate to severe atopic dermatitis (also called eczema, a chronic and/or recurring itchy skin condition)
No signs or symptoms suggestive of active tuberculosis

Age Range

18 - no limit

Healthy Volunteers Needed

No

Duration of Participation

Subjects' participation will last a maximum of 36 weeks (or about 9 months).

Minors Included

No

Contact

Maureen Keene at 503 228 7350

Sponsor

Merck Sharp & Dohme Corporation (a subsidiary of Merck & Co., Inc.)

Recruitment End

05/30/2014

Compensation Provided

Yes

Compensation

Subjects will receive a payment of $100.00 for visits 1, 3-8, and 10-20 and $350.00 for visits 2 and 9 to help cover the cost of travel and expenses (which may include such things as parking, baby-sitting, time off from work, meals, etc.), for a total of up to $2,450.00. If subject does not complete all visits for this study, subject will be paid only for the visits completed.

Additionally, if subjects participate in the optional skin biopsy sub-study, they will receive $75.00 at the baseline visit, at Week 4, and at Week 12, for a possible total of up to $225.00. If subject does not complete all visits for this study, subject will be paid only for the visits completed.


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