Study on Baricitinib for Treating Children Aged 6 to 17 with Alopecia Areata

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What is this study about?

This clinical trial is focused on studying alopecia areata, a condition that causes hair loss, in children aged 6 to less than 18 years. The treatment being tested is called baricitinib, which is taken orally in the form of a tablet or oral suspension. The study aims to determine if different doses of baricitinib are more effective than a placebo in treating children with this condition.

Participants in the study will receive either a high dose or a low dose of baricitinib, or a placebo, over a period of time. The study will monitor the effects of the treatment on hair regrowth and assess the safety of baricitinib in children. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

The main goal of the study is to see if baricitinib can help reduce the severity of hair loss in children with alopecia areata. The study will track the percentage of participants who achieve a significant improvement in their condition. This research is important for understanding how effective baricitinib is in treating alopecia areata in a younger population and could lead to better treatment options in the future.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, which is to evaluate the effectiveness and safety of baricitinib in treating children with alopecia areata, a condition causing hair loss.

You will be randomly assigned to receive either a high dose, a low dose of baricitinib, or a placebo, which is a substance with no active medication.

2 medication administration

You will take the medication orally in the form of a tablet or oral suspension. The exact dosage and frequency will be determined by the study team based on your specific group assignment.

The duration of the medication administration will be specified by the study protocol, and you will be required to follow the instructions provided by the study team.

3 regular check-ups

Throughout the trial, you will attend regular check-ups to monitor your health and the effects of the medication. These check-ups are essential to ensure your safety and to gather data on the medication’s effectiveness.

During these visits, various assessments will be conducted, including physical examinations and possibly laboratory tests.

4 completion of the trial

At the end of the trial, you will have a final assessment to evaluate the overall impact of the treatment on your condition.

The study team will discuss the results with you and provide any necessary follow-up care or recommendations.

Who Can Join the Study?

Must have had severe alopecia areata (AA) for at least 1 year. Alopecia areata is a condition that causes hair loss.
Current episode of AA must have lasted at least 6 months, with hair loss covering 50% or more of the scalp.
Current episode of severe to very severe AA must be less than 8 years long. If the AA has lasted 8 years or more, there must have been times when hair regrowth was observed, either naturally or with treatment, in the past 8 years.
Both males and females can participate.
Participants must be part of a vulnerable population, which means they may need special protection or care.

Who Cannot Join the Study?

Patients who have any other medical condition that might interfere with the study.
Patients who are currently taking any medication that could affect the study results.
Patients who have had a recent infection or illness that could impact their participation.
Patients who have a history of allergic reactions to similar medications.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a history of drug or alcohol abuse.
Patients who have any condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
ICMR (International Center for Medical Research)	Madrid	Spain
Evimed Sp. z o.o.	Warsaw	Poland
Dermedic Jacek Zdybski	Ostrowiec Swietokrzyski	Poland
Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy M. Brzewski, P. Brzewski S.C.	Cracow	Poland
Technische Universitaet Dresden	Dresden	Germany
Royalderm Agnieszka Nawrocka	Warsaw	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Centre Hospitalier Universitaire De Nice	Nice	France
Katholisches Kinderkrankenhaus Wilhelmstift gGmbH	Hamburg	Germany
University Of Pecs	Pecs	Hungary
University Of Debrecen	Debrecen	Hungary
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital General Universitario De Valencia	Valencia	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital Universitario Basurto	Bilbao	Spain
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
Centre D’Etude De La Peau Et Du Cheveu	Paris	France
Care Clinic Sp. z o.o.	Katowice	Poland
Dorota Bystrzanowska High Med Przychodnia Specjalistyczna	Warsaw	Poland
Clnsbi Hnmtjoquyif Rbjfyszl Usouksckavrlv Dy Tulqy	Tours	France
Pzipylefs Ikwxiwlh Morhbomf Mlrfziqklsfe Soydt Waartxziwanz I Atcbfprtrhnpa	Warsaw	Poland
Uihszrxvjp Mxqigtt Cevsxm Htucgbnanreqdnmbq	Hamburg	Germany
Tjdglijdkez uoi Srvptsoqupi Bwnkrimn Gemh	Bad Bentheim	Germany
Pfhuzah 0rf	Warsaw	Poland
Gofalen Dvonjrmrcyemzyc Bjyby Kwdkmke	Kielce	Poland
Muvflmois Ixffyujixp Cmrrgdou Slnpxlpw Str z ocga	Warsaw	Poland
Lodqc Clcnax Sbsq di Txentk Knpoglrpnsz de Aosekrj Kawytjra	Szczecin	Poland
Nbot Smaknfqe Opvjkzy Dstynexcpfzyxbc Dydpjo	Bialystok	Poland
Akdbvjznaa Pvywljvh Hzmpkwqa Dt Mveqaegna	Marseille	France
Uyhsypdnpojlhpulfujex Mskqbeqw Axi	Munster	Germany
Gswksj Uibtyjpbmz Fnvctkazf	Frankfurt	Germany
Ppqopqi Set z odqk	Katowice	Poland
Mqnzrpiyyhlsyzpjsdkvftdhhw Hnhbrsmkrcwvyoxw	Halle (Saale)	Germany
Cwnqsvd Bwnjw Ksfuqbiawnj Pbredkse Spj z obqi	Gdansk	Poland
Hvbfhkvj Uiinqueidhxkj Hbrtavvq Tyldk y Pydbvb Iecgoalt Cpyksb djmeuzujggmmetamj (ruyw	Badalona	Spain
Dpguxzuxobkb Qigkp	Mainz	Germany

Trial status

Country	Status	Recruitment Start
France	Not recruiting	31.08.2023
Germany	Not recruiting	31.08.2023
Hungary	Not recruiting	31.08.2023
Poland	Not recruiting	31.08.2023
Spain	Not recruiting	31.08.2023

Trial locations

Investigated drugs:

Baricitinib

Baricitinib is a medication being tested in this clinical trial for its effectiveness in treating children with alopecia areata, a condition that causes hair loss. It works by blocking certain enzymes in the body that are involved in the immune response, which may help reduce inflammation and prevent hair loss. The trial aims to see if baricitinib can help improve hair growth in children with this condition.

Investigated diseases:

Alopecia areata

Alopecia areata – Alopecia areata is an autoimmune condition characterized by sudden, patchy hair loss on the scalp and other parts of the body. The immune system mistakenly attacks hair follicles, leading to hair falling out in small, round patches. The progression of the disease can vary greatly among individuals, with some experiencing only a few patches of hair loss, while others may lose more extensive areas of hair. In some cases, the hair may regrow on its own, while in others, the condition may persist or worsen over time. The disease can also progress to more severe forms, such as alopecia totalis, which involves complete loss of scalp hair, or alopecia universalis, which involves loss of all body hair. The course of the disease is unpredictable, with periods of hair loss and regrowth.

Trial ID:

2022-502700-78-00

Protocol code:

I4V-MC-JAIO

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Baricitinib for Treating Children Aged 6 to 17 with Alopecia Areata

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?