This clinical trial is focused on studying the long-term safety and effectiveness of a treatment called Nemolizumab for individuals with Atopic Dermatitis, which is a chronic skin condition that causes itchy and inflamed skin. The treatment involves using a solution for injection, which is administered under the skin. The study aims to understand how safe Nemolizumab is for people with moderate-to-severe atopic dermatitis over an extended period.
Participants in the study will receive Nemolizumab, which is also known by its code name CD14152 or CIM331. Some participants may receive a placebo. The study will monitor participants over a long duration to observe any side effects and to assess how well the treatment works in reducing the symptoms of atopic dermatitis. The study will also evaluate the impact of the treatment on the quality of life of the participants.
Throughout the study, participants will have regular visits to track their progress and any changes in their condition. The study will collect information on the severity of the skin condition, the level of itchiness, and any improvements in sleep and daily activities. The goal is to gather comprehensive data on the safety and benefits of Nemolizumab for managing atopic dermatitis.
1joining the study
Upon joining the study, the patient will be assessed to ensure they meet the eligibility criteria. This includes having moderate-to-severe atopic dermatitis and a history of inadequate response to topical treatments.
The patient must agree to apply a moisturizer daily and use authorized topical therapy as needed.
2initial treatment phase
The patient will begin treatment with nemolizumab, administered as a solution for injection under the skin (subcutaneous use).
The dosage and frequency of administration will be determined by the study protocol and the healthcare provider overseeing the trial.
3ongoing treatment and monitoring
Throughout the study, the patient will receive regular injections of nemolizumab and attend scheduled visits to monitor the safety and effectiveness of the treatment.
The patient will be evaluated for any side effects or adverse events, and their atopic dermatitis symptoms will be assessed using various scales and questionnaires.
4long-term follow-up
The study is designed to assess the long-term safety and efficacy of nemolizumab over a period that may extend up to 200 weeks.
During this time, the patient will continue to receive treatment and attend follow-up visits as outlined in the study schedule.
5completion of the study
Upon completion of the study, the patient’s overall response to the treatment will be evaluated.
The patient will be informed about the outcomes and any further steps, if necessary, based on their individual health needs.
Who Can Join the Study?
Adolescents aged 12-17 who have not participated in a previous study with the medication Nemolizumab or those who may benefit from the study, as determined by the study doctor.
Participants must have atopic dermatitis affecting at least 10% of their body surface area.
Participants must have a SCORAD pruritus VAS score of at least 4.0, which measures itchiness on a scale from 0 to 10.
Participants must have a recent history of not responding well to topical medications, which are creams or ointments applied to the skin.
Participants must agree to apply a moisturizer at least once daily and use the approved topical therapy as directed by the study doctor.
Women who can have children must agree to use an effective method of birth control or practice true abstinence during the study and for 12 weeks after the last study drug injection.
Women who cannot have children must meet specific criteria, such as not having menstrual periods for 1 year or having had certain surgeries.
Participants and their guardians, if applicable, must be willing and able to follow all study requirements and schedules.
Participants and their guardians, if applicable, must understand and sign a consent form before any study procedures are done.
Participants must have had chronic atopic dermatitis for at least 2 years, confirmed by specific criteria.
Participants must have an EASI score of at least 16, which measures the severity of eczema.
Participants must have an IGA score of at least 3, which indicates moderate to severe eczema.
Who Cannot Join the Study?
Patients who have a history of severe allergic reactions to any of the ingredients in the study medication.
Individuals with other skin conditions that might interfere with the study, such as psoriasis or eczema not related to atopic dermatitis.
Participants who have used certain medications that could affect the study results, like strong steroids or immunosuppressants, within a specific time before the study starts.
People with a history of certain infections, such as tuberculosis, or those who have tested positive for certain viruses like HIV or hepatitis.
Women who are pregnant or breastfeeding, as the effects of the study medication on unborn babies or infants are not known.
Individuals with a history of drug or alcohol abuse, as this could affect their ability to follow the study procedures.
Patients with certain medical conditions that could make participation unsafe, such as severe heart, liver, or kidney disease.
Anyone who has participated in another clinical trial within a certain period before this study, to avoid interference with the results.
Individuals who are unable to comply with the study requirements, such as attending regular visits or following the treatment plan.
Nemolizumab (CD14152) is a medication being studied for its safety and effectiveness in treating moderate-to-severe atopic dermatitis, a type of eczema that causes itchy and inflamed skin. This trial aims to understand how well Nemolizumab works over a long period and to ensure it is safe for use in adults and adolescents with this skin condition.
Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The skin may become red, swollen, and cracked, and in some cases, blisters may form. The condition tends to flare periodically and then subside. It is commonly associated with other allergic conditions like asthma and hay fever. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors.
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