Active not recruitingPHASE3INTERVENTIONAL

A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

This study is for teenagers and adults who have moderate to severe eczema, also known as atopic dermatitis. It's designed to see how a new medicine called rocatinlimab works over a longer period. Researchers are especially interested in understanding if the medicine remains safe and if people can continue to take it without too many bothersome side effects. They also want to see if it continues to be helpful in managing eczema symptoms. Participants in this study will have already taken part in an earlier study involving rocatinlimab. This new study helps gather important information about the long-term use of this potential new treatment option for people living with eczema.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

2,621

Start

31 May 2023

Estimated completion

22 Jun 2026

Atopic Dermatitis

What is this study about?

Imagine you or someone you know has eczema (atopic dermatitis) that's quite severe and doesn't get much better with standard treatments. Researchers are always looking for new ways to help. This particular study is about a new medicine called rocatinlimab. It’s a follow-up study, meaning it's for people who have already tried rocatinlimab in a previous research trial. The main goal is to understand what happens when people take this medicine for a longer time.

Think of it like this: when a new medicine is first tested, doctors check if it works and if it's safe for a short period. If those initial tests are positive, the next step is often to see how it performs over many months or even years. This helps doctors and patients know what to expect in the long run if the medicine becomes widely available. So, this study carefully watches how safe the medicine continues to be and if people can keep taking it comfortably without major problems.

They also want to learn if rocatinlimab keeps helping to control eczema symptoms effectively over a longer period. This kind of long-term information is really important because eczema is a condition that often lasts for many years. Knowing how a treatment holds up over time helps ensure that new medicines provide lasting benefits and are a good option for managing this challenging skin condition.

Key takeaways

This study is for long-term follow-up of rocatinlimab for eczema.
It's only for people who completed an earlier rocatinlimab study.
The main focus is on long-term safety and whether the medicine keeps working.
Participants must be between 12 and 100 years old.
Close medical monitoring will be provided throughout the study.

Who may be eligible?

This study is for adults and teenagers between 12 and 100 years old. To join, you must have already taken part in one of the previous rocatinlimab studies. These studies were called ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, or ROCKET-VOYAGER. You also need to have finished your last visit in that previous study within the last 28 days.

If you were in the ROCKET-ORBIT study, there's an extra rule: your eczema symptoms, measured by something called an EASI score, needed to have improved by at least 60% by Week 52 of that study, compared to when you first started it.

You wouldn't be able to join this study if you had to stop taking rocatinlimab in the earlier study because of safety concerns, or for reasons that weren't about whether the medicine was helping your eczema. This check happens when you first inquire about the study.

Quick self-check

Did I complete a rocatinlimab study (like ROCKET-IGNITE, ROCKET-HORIZON, etc.) recently?
Was my last visit in that study within the last 28 days?
Am I between 12 and 100 years old?
If I was in the ROCKET-ORBIT study, did my eczema improve by at least 60% by Week 52?
Did I *not* stop the previous study medicine early due to safety concerns?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll continue to receive rocatinlimab. The research team will regularly check in with you to see how you're feeling and how your eczema is responding. This usually involves regular visits to the clinic, where doctors and nurses will perform examinations, ask about your symptoms, and possibly take blood samples.

You'll be carefully monitored for any side effects or changes in your health. The total duration of your participation in this study will vary, as it's designed to look at the long-term effects of the medicine. The research team will explain the full schedule of visits and assessments during the consent process.

Potential risks and benefits

Participating in this study might offer potential benefits, such as continuing to receive a new medicine that could help manage your eczema in the long term, and receiving close medical monitoring. However, as with any medicine, there are potential risks and side effects, which the study team will explain in detail. You might experience side effects from rocatinlimab, or the medicine might not continue to be as effective for your eczema over time. It's important to remember that joining a study is always voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (547)

Cahaba Dermatology and Skin Health Center
Birmingham, United States
Medical Dermatology Specialists
Phoenix, United States
Alliance Dermatology and Mohs Center
Phoenix, United States
Affiliated Dermatology
Scottsdale, United States
Scottsdale Clinical Trials
Scottsdale, United States
Dermatology Trial Associates
Bryant, United States
Burke Pharmaceutical Research
Hot Springs, United States
Arkansas Research Trials, LLC
North Little Rock, United States
Kern Research Inc
Bakersfield, United States
Hope Clinical Research LLC
Canoga Park, United States
West Coast Research LLC
Dublin, United States
California Dermatology and Clinical Research Institute
Encinitas, United States

+535 more sites — see the official record for the full list.

Common questions

What kind of eczema is this study for?

This study is for people with moderate to severe atopic dermatitis, which is a common type of eczema.

Can anyone join this study?

No, this study is specifically for people who have already taken part in one of the earlier rocatinlimab studies for eczema.

What will I be taking in this study?

You will be taking rocatinlimab, the same medicine you received in the previous study.

Why is this study important?

It helps doctors understand how safe and effective rocatinlimab is for eczema over a longer period of time, which is important for long-term health.

How long will I be in this study?

This is a long-term study, so your participation will last for an extended period, which the study team will explain to you.