Purpose of this Study
We are doing this study to find out how effective an experimental drug called rocatinlimab (the study drug) is for people who have moderate-to-severe atopic dermatitis. This study is a continuation of 2 previous clinical trials we conducted for this same study drug: the ROCKET-Horizon and the ROCKET-Astro clinical trials.
Who Can Participate?
Eligibility
Children and adults ages 12+ who were participants in either the ROCKET-Horizon or ROCKET-Astro clinical trials.
For more information, please contact the study team at <a href= "mailto: erin.campo@duke.edu">erin.campo@duke.edu.</a>
For more information, please contact the study team at <a href= "mailto: erin.campo@duke.edu">erin.campo@duke.edu.</a>
Looking for Healthy Participants
No
What is Involved?
This research study is divided into 3 periods:<ul>
<li>The screening period</li>
<li>The study drug period</li>
<li>The follow-up period</li></ul>
If you decide to join this study, you will be enrolled for up to 92 weeks and will visit our clinic 26 times.
During the screening period, if this is your last study visit in one of the previous ROCKET studies and your first day on this study, then you will not need to have any of the screening tests and/or procedures completed, unless the study doctor thinks you need to have them done.
When you enter the study drug period, you will get a random assignment (like drawing numbers from a hat) to one of three groups:<ul>
<li>You might get a 150mg dose of the study drug; OR</li>
<li>You might get a 300 mg dose of the study drug; OR</li>
<li>You might get a placebo (inactive substance with no drug in it)</li></ul>
The study drug/placebo is given as an injection (shot) under the skin about every 4 weeks. The study drug period will last about 72 weeks.
While you are in this study, you will have some of the following tests/procedures done:<ul>
<li>Physical exams</li>
<li>Blood draws</li>
<li>Skin exams</li>
<li>EKG</li></ul>
After you stop taking the study drug/placebo, we will schedule you to come in for a follow-up visit about 4 months later.
<li>The screening period</li>
<li>The study drug period</li>
<li>The follow-up period</li></ul>
If you decide to join this study, you will be enrolled for up to 92 weeks and will visit our clinic 26 times.
During the screening period, if this is your last study visit in one of the previous ROCKET studies and your first day on this study, then you will not need to have any of the screening tests and/or procedures completed, unless the study doctor thinks you need to have them done.
When you enter the study drug period, you will get a random assignment (like drawing numbers from a hat) to one of three groups:<ul>
<li>You might get a 150mg dose of the study drug; OR</li>
<li>You might get a 300 mg dose of the study drug; OR</li>
<li>You might get a placebo (inactive substance with no drug in it)</li></ul>
The study drug/placebo is given as an injection (shot) under the skin about every 4 weeks. The study drug period will last about 72 weeks.
While you are in this study, you will have some of the following tests/procedures done:<ul>
<li>Physical exams</li>
<li>Blood draws</li>
<li>Skin exams</li>
<li>EKG</li></ul>
After you stop taking the study drug/placebo, we will schedule you to come in for a follow-up visit about 4 months later.
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety,
Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With
Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)
Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With
Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)
Principal Investigator
Rabina
Walsh
Protocol Number
PRO00114287
NCT ID
NCT05882877
Phase
III
Enrollment Status
Pending Open to Enrollment