IRB #

STUDY00016992

Title

A PHASE 2/3 STUDY INVESTIGATING THE PHARMACOKINETICS,
SAFETY, AND EFFICACY OF DUPILUMAB IN PATIENTS AGED
≥6 MONTHS TO <6 YEARS WITH SEVERE ATOPIC DERMATITIS (R668-AD-1539)

Principal Investigator

Eric Simpson

Study Purpose

The purpose of this study is to determine the safety and efficacy of the investigational drug in children ≥ 6 months to <6 years of age who have been diagnosed with atopic dermatitis, also known as eczema.

Medical Condition(s)

atopic dermatitis, eczema, AD

Eligibility Criteria

Your child must be male or female ≥6 months to <6 years of age at the screening visit. Subjects must have a documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s).

Subjects CANNOT have any of the following:
- Significant medical conditions other than atopic dermatitis
- Active or chronic skin infection
- Treatment with a topical investigational drug within 2 weeks
- History of cancer
- Treatment with a TCI within 2 weeks prior to the baseline visit
- Treatment with crisaborole within 2 weeks prior to the baseline visit
- Prior treatment with dupilumab.

Healthy Volunteers Needed

No

Placebo Chance

50%

Duration of Participation

If you join the study, your child will be in the study for 36 weeks and have 9 visits to OHSU.

Minors Included

Yes

Contact

call 503-418-9386 or e-mail dermtrials@ohsu.edu

Sponsor

Regeneron Pharmaceuticals, Inc.

Recruitment End

11/30/2021

Compensation Provided

No


Go Back