This study is examining the effectiveness and safety of rocatinlimab (AMG 451) in treating adults with moderate-to-severe atopic dermatitis. Atopic dermatitis is a chronic inflammatory skin condition characterized by itchy, red, swollen, and cracked skin, commonly known as eczema. The purpose of this research is to evaluate how well rocatinlimab works compared to a placebo over a 24-week period.
The study will assess improvement in atopic dermatitis using several measurements, including the Validated Investigator’s Global Assessment for Atopic Dermatitis (a scoring system used by doctors to rate the severity of eczema) and the Eczema Area and Severity Index (a tool that measures the extent and severity of eczema). The research will also track changes in pruritus (itching) and skin pain using numerical rating scales where patients rate their symptoms.
During the 24-week study period, participants will receive either rocatinlimab or placebo treatment. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication versus the placebo until the study is complete. This approach helps ensure that the results aren’t influenced by expectations about the treatment.
Who Can Join the Study?
You must be at least 18 years old or the legal adult age in your country, whichever is older
You must have been diagnosed with atopic dermatitis (a chronic, itchy skin condition also known as eczema) that has been present for at least 12 months before joining the study
You must have a history of inadequate response to topical treatments (creams or ointments applied to the skin) or have medical reasons why topical treatments are not advisable for you
You must have moderate-to-severe atopic dermatitis as defined by:
An EASI score (Eczema Area and Severity Index, which measures the extent and severity of eczema) of 16 or higher
A vIGA-AD score (Validated Investigator’s Global Assessment for Atopic Dermatitis, which rates overall eczema severity) of 3 or higher
At least 10% of your body surface area affected by atopic dermatitis
A pruritus NRS (Numerical Rating Scale for itching) score of 4 or higher, indicating moderate to severe itching in the past 7 days
Who Cannot Join the Study?
Having a diagnosis other than atopic dermatitis
Having used medications that affect the immune system (like systemic immunosuppressants) within a certain period before the study
Having used topical treatments for atopic dermatitis within a specified time before the study
Having received light therapy (like phototherapy) recently
Having an active skin infection that requires treatment
Having other skin conditions that might interfere with evaluating atopic dermatitis
Being pregnant or breastfeeding
Having significant liver or kidney problems
Having a history of cancer (except for certain skin cancers that have been completely removed)
Having a history of serious infections
Having active tuberculosis or other serious infections
Having participated in another clinical trial recently
Having previously used rocatinlimab (the study medication)
Having any condition that, in the opinion of the study doctor, would make it unsafe to participate
Rocatinlimab (also known as AMG 451) is a medication being studied for the treatment of moderate-to-severe atopic dermatitis, which is a chronic inflammatory skin condition commonly known as eczema. This medication is designed to help reduce inflammation and improve symptoms like itching, redness, and rash that are associated with atopic dermatitis.
Placebo is a substance that contains no active medication. In this study, it’s used as a comparison to determine if rocatinlimab is effective. Some participants receive the actual medication while others receive the placebo, allowing researchers to measure the true effect of the medication.
Atopic Dermatitis – A chronic inflammatory skin condition characterized by intense itching and red, dry, scaly patches. It typically begins in childhood and may improve or worsen over time, appearing in flares triggered by various environmental factors. Atopic dermatitis often affects the skin folds, such as those inside the elbows, behind the knees, and on the face and neck. The condition can cause significant discomfort due to persistent itching, which may lead to skin damage from scratching. Many patients with atopic dermatitis also have other allergic conditions like asthma or hay fever.
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