All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

We are inviting children and teenagers, from 6 months up to 17 years old, who have moderate to severe eczema to take part in this important study. The main goal is to test a new medicine called lebrikizumab. We want to find out how effective it is at treating eczema, whether it has any side effects, and how the body processes it. Some participants will receive lebrikizumab, others a dummy medicine (placebo), and some will use a standard cream (topical corticosteroid). This research aims to understand if lebrikizumab could be a new and helpful treatment option for young people living with eczema.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Eli Lilly and Company
Enrolment target
367
Start
18 Oct 2022
Estimated completion
01 Dec 2026

What is this study about?

This study is all about helping children and teenagers who have moderate to severe eczema, also known as atopic dermatitis. Eczema can be really uncomfortable, causing itchy, red, and dry skin, and it can affect day-to-day life for young people and their families. We're looking into a new medication called lebrikizumab to see if it can make a real difference.

The main aim is to understand three key things about lebrikizumab: first, how well it treats the eczema symptoms; second, if it's safe to use and what side effects might occur; and third, how the body absorbs and uses the medicine. There will be different groups in the study; some children will receive the new medicine, others will receive a 'dummy' medicine (placebo) which looks the same but contains no active drug, and some will use a standard eczema cream (topical corticosteroid). This helps us compare the effects fairly.

By taking part, you and your child would be helping researchers learn more about eczema and potentially find new and better ways to treat it for thousands of other young people in the future. All information gathered is kept confidential, and the safety and well-being of every participant is always the top priority.

Key takeaways

  • This study is for children and teenagers with moderate to severe eczema.
  • It tests a new medicine called lebrikizumab against a dummy medicine or standard cream.
  • The goal is to find out if lebrikizumab is effective and safe.
  • Participants range from 6 months to 17 years old.
  • Close medical care and monitoring will be provided throughout the study.

Who may be eligible?

To join this study, your child needs to have been diagnosed with eczema for a certain amount of time before the study starts. For children aged 6 years and older, they need to have had eczema for at least 12 months. For those aged 2 to under 6 years, it's at least 6 months, and for babies and toddlers aged 6 months to under 2 years, it's at least 3 months. Their eczema also needs to be considered 'moderate to severe' by the study doctors based on specific assessments of their skin.

There are also some reasons why someone might not be able to join. For example, if your child has recently taken part in another medical study involving a new medicine in the last 8 weeks, they usually can't join this one. Also, treatments like certain eczema medications (like dupilumab) or specific vaccinations received shortly before the study might mean your child can't take part, at least for a period of time. The study team will review all of these details carefully with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Is your child aged between 6 months and 17 years?
  2. Has a doctor diagnosed your child with eczema (atopic dermatitis)?
  3. Is your child's eczema currently moderate to severe?
  4. Has your child not just taken part in another clinical trial (within the last 8 weeks)?
Answer every question to see your result.

What does participation involve?

If your child participates, they will be given either the new medicine (lebrikizumab), a dummy medicine (placebo), or a standard eczema cream called a topical corticosteroid. You won't know which one your child is receiving, and this is standard practice in clinical trials to ensure fair results. Your child will have regular visits to the clinic where doctors and nurses will monitor their eczema, take measurements (like blood tests), and check how they are feeling. These visits help us track how the treatment is working and if there are any side effects. The total duration of your child's involvement in the study will be explained in full by the study team, including how long the treatment period lasts and any follow-up appointments.

Potential risks and benefits

Taking part in a study like this could bring several potential benefits. Your child might have access to a new treatment before it's widely available, and they'll receive close medical attention and monitoring throughout the study. However, there are also potential risks, as with any medication, including potential side effects from the study treatments. There's also no guarantee that the new medicine will work for your child. It's really important to remember that participating is completely voluntary, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (85)

  • Clinical Research Center of Alabama
    Verified postcode
    Birmingham, United States
  • Phoenix Children's Hospital
    Verified postcode
    Phoenix, United States
  • Arkansas Research Trials
    Verified postcode
    North Little Rock, United States
  • First OC Dermatology
    Verified postcode
    Fountain Valley, United States
  • Antelope Valley Clinical Trials
    Verified postcode
    Lancaster, United States
  • Dermatology Research Associates
    Verified postcode
    Los Angeles, United States
  • Integrative Skin Science and Research
    Verified postcode
    Sacramento, United States
  • Rady's Children Hospital San Diego - Dermatology
    Verified postcode
    San Diego, United States
  • UConn Health
    Verified postcode
    Farmington, United States
  • Solutions Through Advanced Research
    Verified postcode
    Jacksonville, United States
  • ForCare Clinical Research
    Verified postcode
    Tampa, United States
  • Treasure Valley Medical Research
    Verified postcode
    Boise, United States

Common questions

What is eczema?

Eczema, or atopic dermatitis, is a common skin condition that makes your skin red, itchy, and dry. It's not infectious.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks like the real treatment but contains no active ingredients. It helps us see if the new medicine really works better than no treatment.

Will my child definitely get the new medicine?

No, not necessarily. Participants are randomly assigned to receive either the new medicine, a placebo, or a standard eczema cream during the main part of the study.

What are 'topical corticosteroids'?

These are creams or ointments applied to the skin that contain steroid medicine to reduce inflammation and itching in eczema.

Is this study safe for my child?

Clinical trials are carefully designed with patient safety as the highest priority. Your child will be closely monitored by a medical team throughout the study.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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