About the Level-Up Study

Level-Up Study | skin rashes
Level-Up Study | skin rashes
Level-Up Study | skin rashes
Level-Up Study | skin rashes

What is the Level-Up Study?

The purpose of this study is to find out how safe and effective the study medication is compared with another approved atopic dermatitis (AD) medication. This study may give healthcare providers more information about the use of these medications for managing moderate to severe AD.

About 880 adolescent and adult patients (between 12 and 64 years of age and at least 40 kg or 88 lbs) with moderate to severe AD will take part in this study worldwide.

What to expect

Study participants will be in the Level-Up Study for approximately 41 weeks (about 10 months). You or your child will be assigned randomly (by chance) to receive either the study medication or dupilumab at the Baseline/Day 1 visit.

The study periods

The Level-Up Study is split into 4 periods: a Screening Period, 2 Study Treatment Periods, and a Follow-Up Period.

1

Screening Period

(Within 35 days prior to the Baseline)

  • You or your child will visit the study center to see if the study is suitable for them and if they want to take part.

2

Study Treatment Period 1

(16 weeks)

  • You or your child will visit the study center approximately 6 times for study assessments.
  • Participants receiving the study medication will take the medication by mouth once daily.
  • Participants receiving dupilumab will have an injection under their skin once every other week after the first dose at the Day 1 visit when 2 injections will be given.
  • After receiving the assigned study medication for 16 weeks, the study doctor will check to see if your or your child’s skin has responded to treatment at a study center visit
    • If your or your child’s skin has improved with the study medication, you or your child will complete the study and enter the Follow-Up Period.
    • If you or your child’s skin has not improved based on certain criteria or has gotten worse, you or your child will enter Period 2.
3

Study Treatment Period 2

(16 weeks)

  • There will be approximately 2 visits to the study center for study assessments.
  • The study medication may change during this period, depending on how you or your child’s skin responds to the treatment based on certain criteria.
4

Follow-Up Period

(30 days or 12 weeks)

  • The timing for entering the Follow-Up Period will depend on how you or your child’s AD responds to treatment.
    • If you or your child were in the study medication group, there will be a 30-day Follow-Up Period.
    • If you or your child were in the dupilumab group, there will be a 12-week Follow-Up Period.