This study focuses on patients with atopic dermatitis, a chronic skin condition that causes itchy, inflamed skin. The research examines a medication called rocatinlimab (also known as AMG 451) that is given as an injection under the skin. The study aims to understand how safe and effective this medication is when used for a long period in people who have moderate to severe forms of atopic dermatitis.
The study is designed to continue treatment for patients who have already participated in previous research with rocatinlimab. Participants will receive either rocatinlimab or placebo through injections under the skin. This is a long-term study that will monitor how well patients maintain improvement in their skin condition and any side effects that may occur during treatment.
The research will track various aspects of the skin condition, including changes in skin appearance, itching severity, and overall symptoms. The study will particularly focus on monitoring the safety of the treatment by recording any side effects and checking laboratory test results and vital signs throughout the treatment period.
1Initial qualification
You must have completed treatment in a previous rocatinlimab study
If you participated in study 20210263, you need to show specific improvement in your EASI score (a measure of atopic dermatitis severity) at Week 52
2Treatment assignment
You will be assigned to receive either rocatinlimab or placebo
The medication will be given as an injection under the skin (subcutaneous injection)
Neither you nor your doctor will know which treatment you are receiving (this is called double-blind)
3Treatment period
The study will continue from October 2023 to February 2027
During this time, your skin condition will be regularly evaluated using several measurement scales:
– vIGA-AD and rIGA scales (measures of skin appearance)
– EASI score (measures the extent and severity of skin symptoms)
– Pruritus NRS score (measures itching intensity)
Your health will be monitored for any side effects or significant changes in laboratory tests and vital signs
4Regular assessments
Your progress will be tracked to see if improvements in your skin condition are maintained
The study team will monitor:
– Any changes in your skin clearance
– Whether improvements in itching are maintained
– Any side effects that may occur during treatment
Who Can Join the Study?
You must have completed treatment in a previous rocatinlimab study (a medication for atopic dermatitis)
If you participated in study 20210263, you must have shown improvement in your EASI score (a measure of eczema severity) at Week 52
You can be either male or female
You must be at least 12 years old
You must have moderate-to-severe atopic dermatitis (a chronic inflammatory skin condition causing itchy, red, and scaly skin)
You must be able to understand and follow study procedures and requirements
You must be willing to attend all required study visits and complete study assessments
Who Cannot Join the Study?
History of serious allergic reactions or anaphylaxis (severe, potentially life-threatening allergic reaction)
Active or chronic infections, including tuberculosis, hepatitis B, hepatitis C, or HIV
Current diagnosis of cancer or history of cancer in the past 5 years
Rocatinlimab is a medication being studied for treating moderate to severe atopic dermatitis (a serious type of eczema). It is designed to help reduce inflammation and symptoms of atopic dermatitis in both adults and teenagers. This medication works by targeting specific parts of the immune system that are involved in causing skin inflammation and itching.
Atopic Dermatitis – A chronic inflammatory skin condition that causes dry, itchy, and inflamed skin. The condition typically begins in early childhood but can occur at any age and tends to flare up periodically. It causes the skin to become red, scaly, and intensely itchy, often appearing in patches on the face, hands, feet, and in body folds. The condition frequently occurs in people who have a personal or family history of allergies or asthma. During flare-ups, the affected skin may become cracked, raw, or weepy, and the persistent itching can lead to scratching that further damages the skin barrier.
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