Purpose of this Study
We are doing this study to find out if an experimental drug called rocatinlimab (the study drug) is a safe and effective option for adolescents with atopic dermatitis (eczema).
Who Can Participate?
Eligibility
Adolescents ages 12-18 who:
- Are diagnosed with atopic dermatitis (eczema)
- Weight at least 88 lbs.
Age Range
12-18
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is broken up into 6 periods:
1) The screening period
2) Initial study drug period
3) Maintenance study drug period
4) Open-label period
5) End of study
6) Safety follow-up
If your child joins this study, they will have a screening period that will last up to 30 days and involve at least 2 in-person clinic visits. During the screening period, your child will have the following tests and procedures:
- Physical exam
- Blood work
- Skin swab
- Vital signs
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe
Atopic Dermatitis (AD) (ROCKET-ASTRO)
Atopic Dermatitis (AD) (ROCKET-ASTRO)
Principal Investigator
Rabina
Walsh
Protocol Number
PRO00112618
NCT ID
NCT05704738
Phase
III
Enrollment Status
Open to Enrollment