Study of ritlecitinib for treating severe alopecia areata in children aged 6 to under 12 years

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What is this study about?

This clinical trial focuses on children aged 6 to under 12 years who have severe alopecia areata, a condition that causes hair loss on the scalp. The study aims to evaluate how well a medication called ritlecitinib (also known as PF-06651600) works compared to placebo in helping regrow lost scalp hair in children with this condition.

The study medication ritlecitinib comes in the form of hard capsules and will be taken by mouth. Participants will receive either ritlecitinib at doses of 30 mg or 50 mg per day, or a placebo. The treatment period will last for 24 weeks, which is approximately 6 months.

During the study, researchers will monitor how well the medication works by measuring hair regrowth on the scalp. They will also track any side effects that may occur. The study will collect information about how the treatment affects the participants’ daily activities and emotional well-being. Blood samples will be taken to measure the amount of medication in the body at specific times during the study.

1 Initial assessment

Your eligibility for the study will be evaluated based on your age (between 6 and 12 years) and hair loss condition

You must have at least 50% scalp hair loss due to alopecia areata and no hair regrowth in the past 12 months

Previous unsuccessful hair loss treatments will be reviewed

2 Treatment assignment

You will be randomly assigned to receive either ritlecitinib capsules or placebo capsules

The capsules need to be taken by mouth daily

Neither you nor your doctor will know which treatment you are receiving

3 24-week treatment period

Regular check-ups will monitor your progress

Your scalp hair growth will be measured using the SALT score (a method to measure hair loss)

Blood samples will be collected at week 4 or 8 to measure medication levels

Your doctor will assess any changes in your eyebrows and eyelashes if applicable

4 Monitoring and evaluation

Your health will be monitored for any side effects throughout the study

You and your parent/guardian will complete questionnaires about how you feel and how the hair loss affects your daily life

The main goal is to achieve a SALT score of 10 or less by week 24, indicating significant hair regrowth

The study team will evaluate how well you tolerate taking the medication

Who Can Join the Study?

Must be between 6 and 11 years old when starting the study
Must have been diagnosed with alopecia areata (a condition causing hair loss in patches) with at least 50% scalp hair loss
The hair loss must have been present for at least 12 months without any signs of natural hair regrowth
Must have previously tried other treatments for hair loss that did not work, such as:
- Topical treatments (medicines applied directly to the scalp)
- Other medications
- Hair pieces or wigs
Both boys and girls can participate in the study
The scalp hair loss must be measured using a SALT score (Severity of Alopecia Tool) of 50 or higher at both initial screening and baseline visits
The condition can include complete hair loss on the scalp (alopecia totalis) or complete hair loss on the entire body (alopecia universalis)

Who Cannot Join the Study?

People who have a serious or active infection, including tuberculosis or hepatitis B
Those with a compromised immune system (weakened ability to fight infections)
Individuals who have received live vaccines within 4 weeks before starting the study
People with significant heart problems or uncontrolled high blood pressure
Those with severe kidney or liver problems
People who have or had any type of cancer in the past 5 years (except successfully treated skin cancer)
Pregnant or breastfeeding women
People taking certain medications that could interact with the study drug
Those who participated in another clinical trial within the past 30 days
People with a history of serious allergic reactions to medications
Individuals with untreated thyroid disease
Those with a history of blood disorders
People who abuse drugs or alcohol
Those who cannot follow the study protocol or attend regular visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy M. Brzewski, P. Brzewski S.C.	Cracow	Poland

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Beaujon	Clichy	France
Fakultni Nemocnice Bulovka	Prague	Czechia
Dermoklinika Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak	Lodz	Poland
Cdlzmhehvz Ptqsegpwwca Lmvyrwnbnhslmqknmholnvq Mozqxtkg shcth	Wroclaw	Poland
Fqtjadmk Nlmqleetf Bupy	Brno	Czechia
Atpjhos Uxyfc Sdbujmbgw Lhyglz Dg Bisqizy	Bologna	Italy
Pxbtrbb Snt z omzs	Katowice	Poland
Hsetpbvj Dt Lp Syuqp Cjzt I Sdud Pcx	Barcelona	Spain
Hppeiqrn Ssam Jlys Ds Dud Beghkkfio	Esplugues De Llobregat	Spain
Civnmt Hdbunamroul Lvfe Swg	Pierre Benite	France
Uuyavgzhqe Djntu Sjeoh Dm Bsgpful	Brescia	Italy
Kzjbwnn Aalhitnms Smj z otxo	Warsaw	Poland
Fshjileb Ncnzrwjtl Pqgic	Plzen	Czechia
Aodcpnt Oezlkroqjvwsfkcmvmcchnntj Pueuyavtovq Gv Rucgjeifcfgj Mgbpg Dz Cceyxlq	Catania	Italy
Uwcqajceecihs Sgghqdg Kuybjgojk Ijbxwvyuwlgn Cbvjocb W Rmtwcroza	Rzeszow	Poland
Pjbketz Puawfgqggjz Siz z ozgh	Warsaw	Poland
Gxqgmvctzb Drp Hpivonko Dd Lnobjtzqvrxomsdd Cvthioqffn Dx Lfwdd	Lomme	France
Ctuutp Hspscpfuojt Ukuebpwumguyx Dt Dpsys	Dijon	France
Ptfejilcs Ipkydhnc Mcyglnno Mtteuvfthdcc Srekr Wirpkzncklzd I Abvffxcghgkui	Warsaw	Poland
Hicdexkc Dcjyp Nmng	Romans-Sur-Isere	France
Udniranyeczneu Ctgtbgf Kuzqnkxab Wxbhqgtkuglwz Usidahwpmieu Mfgsetuypt	Warsaw	Poland
Lzpqgob Eshxgdp Sds z odth	Ozarowice	Poland
Zcmlfht Myi Smg z okai	Lublin	Poland
Kgbrrma Oyxhqvtez &indg Tbiyaopgu Ska z onti	Warsaw	Poland
Riklqcjrv Avupgzswr Nwtsprqt	Warsaw	Poland
Pjdsz Mjngw Phtj Aapdgppciom Dazqzg Mmm	Prague	Czechia
Nagmsxscgxvd Zfrfnr Oncuxa Zcapgocxzo Spebmlbkplmwasy Omguibz Drlfifhjsbaqwqo &xtpxjtrggyfczgykuge	Bialystok	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	14.07.2025
France	Not recruiting	14.07.2025
Italy	Not recruiting	14.07.2025
Poland	Not recruiting	14.07.2025
Spain	Not recruiting	14.07.2025

Trial locations

Ritlecitinib is a medication being studied for treating severe alopecia areata in children. It works by targeting specific enzymes in the body that are involved in the immune response, which may help reduce inflammation and promote hair regrowth. This medication is being tested to see if it can help children who have lost significant amounts of scalp hair due to alopecia areata, an autoimmune condition where the body’s immune system attacks hair follicles.

Placebo is also used in this trial as a control substance to compare with the active medication.

Alopecia areata – A condition where the immune system attacks hair follicles, causing patches of hair loss on the scalp and sometimes other parts of the body. The hair loss typically occurs in round or oval patches, and the affected skin appears smooth and normal. The condition can develop suddenly over a few days and may affect people of any age or gender. The hair follicles remain alive during this process, which means hair can potentially regrow. The pattern and extent of hair loss can vary significantly between individuals, from small patches to complete loss of scalp hair.

Trial ID:

2024-515438-33-00

Protocol code:

B7981027

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of ritlecitinib for treating severe alopecia areata in children aged 6 to under 12 years

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