Purpose of the ADvocate Studies.

The purpose of the ADvocate Studies is to evaluate the safety and effectiveness of an injectable investigational medication for moderate to severe atopic dermatitis.

Who is eligible?

An eligible participant for these studies must:

  • Be an adult or adolescent, 12 years of age or older, and weigh at least 40 kg (88 lb.)
  • Have chronic atopic dermatitis for at least one year
  • Have a history of inadequate response to topical treatments for atopic dermatitis

Additional eligibility criteria will be assessed by the study doctor or staff during the screening process prior to being enrolled in one of these studies and receiving any investigational medication. Not all individuals will qualify to participate.

What to expect.

Participation in one of the ADvocate Studies may last between 30 and 66 weeks and consists of three parts:

  • During a screening period of up to 30 days, the study doctor will perform tests and procedures to determine if you or your child is eligible to participate.
  • If eligible, you or your child will enter one of the treatment periods, depending on the study you or your child qualifies for. In one treatment period option, you or your child will be assigned to and begin receiving the investigational medication. In the other, you or your child will be randomly assigned to receive either the investigational medication or a placebo (which contains no active medication). The investigational medication and the placebo are both delivered as injections. Depending on the study you or your child qualifies for, the treatment period may last between 16 and 52 weeks. The study doctor will explain all study requirements and length of participation in greater detail during the screening period.
  • You or your child may stop participating by scheduling a safety follow-up visit approximately 12 weeks after the last dose of investigational medication. Or, if at the end of the treatment period you or your child meet certain criteria, you or your child may be eligible to continue receiving the investigational medication in a separate long-term extension study.

Those who qualify may receive either the investigational medication or a placebo (depending on the study assignment and treatment assignment), as well as study-related medical exams and laboratory tests, all at no cost. Compensation for travel may also be available.

Depending on which study you or your child participates in, you and the doctors may or may not know the treatment assignment. For one of the treatment assignments, participants will receive the investigational medication and everyone will know it. For the other, participants will be randomly assigned to receive either the investigational medication or a placebo, and neither the participants nor the study team will know the treatment assignment, but in case of an emergency, the study doctor can quickly find out.

Have any questions? The answers to these FAQs may be able to help.