Alla studier
RekryteringFAS3INTERVENTIONELL

En studie av Baricitinib (LY3009104) hos barn från 6 år till under 18 år med Alopecia Areata

This research study is investigating a new medication called baricitinib for children and teenagers aged 6 to 17 who have severe alopecia areata. Alopecia areata is a condition where the body's immune system mistakenly attacks hair follicles, leading to hair loss. The main goal of this study is to find out how well baricitinib works to help hair regrow and whether it is safe for young people. Participants will receive either baricitinib or a placebo (a dummy drug with no active medicine) in the first part of the study. The study involves several stages, including an initial check-up period, a main treatment period, and a longer-term follow-up to see how participants do over time. This research is important because it could offer a new treatment option for young people living with this challenging condition.

Överblick

Status
Rekrytering
Fas
FAS3
Sponsor
Eli Lilly och Company
Inskrivningsmål
595
Starta
27 feb 2023
Beräknad slutförande
01 Sep 2033

Vad handlar denna studie om?

This study is about a medicine called baricitinib and its use in treating severe alopecia areata in young people. Alopecia areata is an autoimmune condition, meaning the body's own immune system wrongly attacks hair follicles. This leads to hair loss on the scalp and sometimes other parts of the body. For children and teenagers, living with this condition can be particularly difficult, affecting their self-esteem and daily life.

The study aims to understand two main things: how effective baricitinib is at helping hair regrow, and if it is safe for children and teenagers. Baricitinib works by calming down the overactive immune system that causes hair loss in alopecia areata. Researchers want to see if this medicine can make a real difference for young people who haven't found other treatments helpful.

Participants will be given either baricitinib or a placebo, which looks exactly like the study medicine but contains no active ingredients. This is a common way to test new medicines fairly, so researchers can accurately tell if any improvements are due to the treatment itself. The study has different stages, starting with checks to ensure participants are suitable, moving into the main treatment period, and then a longer follow-up period to monitor progress.

Viktiga punkter

  • This study is for children and teenagers (6-17) with severe alopecia areata.
  • It's testing a medicine called baricitinib for safety and hair regrowth.
  • Participants will receive either baricitinib or a dummy medicine (placebo) in the first phase.
  • The study involves regular visits, check-ups, and can last for several years.
  • It could offer a new treatment option for young people with alopecia areata.
  • Du kan dra dig ur studien när som helst.

Vem kan vara berättigad?

To be considered for this study, young people generally need to be between 6 and 17 years old and have had severe alopecia areata for at least a year. Their current hair loss episode should have lasted for at least six months, and a specific measure of hair loss, called a SALT score, needs to be 50% or higher. This score helps doctors understand how much hair loss there is. Participants should also have tried at least one other treatment for their alopecia that didn't work.

There are also reasons why someone might not be able to join. For example, if they have certain other health conditions, such as other types of hair loss, untreated high blood pressure, or serious heart, liver, or kidney problems. The study also cannot include individuals who have been largely unable to care for themselves or have had major surgery recently. It's important that participants don't have certain infections like active hepatitis B or C.

Kan denna studie passa dig?

Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.

  1. Är du mellan 6 och 17 år gammal?
  2. Have you had severe alopecia areata for at least one year?
  3. Has your current hair loss episode lasted at least six months?
  4. Have you tried at least one other treatment for alopecia areata that didn't work?
  5. Do you have any other serious long-term health conditions?
  6. Have you had a major surgery recently or are you likely to need one during the study?
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

If you decide to take part, the study will involve several stages over a long period. First, there's a 5-week 'Screening' period where doctors will do tests to see if you're suitable for the study. If you are, you'll then enter a 'Double-Blind Treatment Period' lasting for 36 weeks. During this time, you'll be given either the study medicine (baricitinib) or a placebo, but neither you nor your doctor will know which one you're receiving.

After this, there's an 'approximately 2-year Long-Term Extension' period where all participants who continue in the study will likely receive the active medicine. Finally, there's a 4-week 'Post-treatment Follow-up' to check on your health after the main treatment ends. Some participants might even be able to continue receiving treatment for even longer, up to a total of 180 weeks. Throughout the study, you'll have regular visits to the clinic for check-ups, blood tests, and to see how your hair is responding.

Potentiella risker och fördelar

Taking part in a clinical trial offers the potential benefit of accessing a new treatment that might help with your condition, especially if other treatments haven't worked. You would also be contributing to medical research that could help other young people with alopecia areata in the future. However, there are potential risks, as with any medicine. Baricitinib could have side effects, which would be explained in detail by the study team. You might also receive the placebo and not the active drug during the initial phase, meaning your condition might not improve. It's crucial to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (127)

  • Total Skin and Beauty Dermatology Center, PC
    Verifierat postnummer
    Birmingham, USA· Rekrytering
  • University of Alabama i Birmingham
    Verifierat postnummer
    Birmingham, USA· Rekryterar inte ännu
  • Investigate MD
    Verifierat postnummer
    Scottsdale, USA· Rekrytering
  • California Dermatology & Clinical Research Institute
    Verifierat postnummer
    Encinitas, USA· Rekryterar inte ännu
  • Dermatology Research Associates
    Verifierat postnummer
    Los Angeles, USA· Rekrytering
  • University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
    Verifierat postnummer
    San Diego, USA· Rekrytering
  • The Permanente Medical Group, Inc.
    Verifierat postnummer
    San Francisco, USA· Rekrytering
  • Southern California Dermatology, Inc.
    Verifierat postnummer
    Santa Ana, USA· Rekrytering
  • Dermatology Physicians of Connecticut
    Verifierat postnummer
    Fairfield, USA· Rekryterar inte ännu
  • Skin Care Research, Inc
    Verifierat postnummer
    Boca Raton, Förenta staterna· Rekryterar inte ännu
  • Florida Academic Centers Research and Education, LLC
    Verifierat postnummer
    Coral Gables, United States· Avslutad
  • D&H Doral Research Center LLC
    Verifierat postnummer
    Doral, USA· Rekryterar inte ännu

Vanliga frågor

What is alopecia areata?

Alopecia areata is a condition where your body's immune system mistakenly attacks your hair follicles, causing hair to fall out, usually in patches.

What is baricitinib?

Baricitinib is a medicine that works by calming down certain parts of your immune system that are overactive in conditions like alopecia areata.

Vad är en placebo?

A placebo is a 'dummy' pill or treatment that looks exactly like the real medicine but contains no active ingredients. It's used to compare against the real medicine.

Hur länge kommer studien att pågå?

The main part of the study lasts about 36 weeks, but with screening, extensions, and follow-up, your overall participation could be up to about 3 years, and potentially longer for some.

Kommer jag definitivt att få den aktiva medicinen?

In the initial 36-week treatment period, you have a chance of receiving either the active medicine or a placebo. In the longer-term extension period, participants typically receive the active medicine.

Hur du får reda på mer

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.

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