Study on the Safety and Effectiveness of Upadacitinib for Adults and Adolescents with Severe Alopecia Areata

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What is this study about?

This clinical trial is focused on studying the condition known as Alopecia Areata, which is a type of hair loss that can affect the scalp and other parts of the body. The study will evaluate the safety and effectiveness of a medication called Upadacitinib, which is taken as a modified-release tablet. This means the tablet is designed to release the medication slowly over time. The study will compare the effects of taking Upadacitinib at different doses to a placebo, which is a tablet that does not contain the active medication.

The purpose of the study is to assess how well Upadacitinib works in reducing the signs and symptoms of severe Alopecia Areata in both adults and adolescents. Participants will be randomly assigned to receive either Upadacitinib or a placebo. The study will be conducted in several phases. Initially, participants will take the medication or placebo for a period of 24 weeks. After this period, some participants may continue in an extended phase of the study for up to 160 weeks, where the long-term effects and safety of the medication will be further evaluated.

Throughout the study, participants will be monitored to see how their condition responds to the treatment. The main goal is to determine if Upadacitinib can help reduce hair loss and improve hair regrowth in those with severe Alopecia Areata. The study will also look at the safety of the medication and how well it is tolerated by participants over time. This research aims to provide valuable information on the potential benefits of Upadacitinib for individuals affected by this condition.

1 Joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age and the severity of alopecia areata, a condition characterized by hair loss.

Participants must have a current episode of alopecia areata lasting less than 8 years.

2 Initial treatment phase

The initial phase lasts from the start of the study to Week 24.

Participants receive either upadacitinib or a placebo. Upadacitinib is administered as a modified-release tablet taken orally once daily.

Two dosages are used: 15 mg and 30 mg.

3 Evaluation at Week 24

The primary goal is to achieve a SALT score of 20 or less, indicating less than or equal to 20% scalp hair loss.

Secondary goals include improvements in eyebrow and eyelash hair loss, and overall scalp hair assessment.

4 Blinded extension phase

From Week 24 to Week 52, participants continue treatment to further evaluate the effects of upadacitinib.

The same dosages of 15 mg and 30 mg are used.

5 Long-term treatment phase

From Week 52 to Week 160, the study assesses long-term safety and effectiveness.

Participants may continue with 30 mg, reduce to 15 mg if a sustained response is achieved, or increase to 30 mg if necessary.

Who Can Join the Study?

  • Participants must be adults under 64 years old. In some places outside the US and EU, adolescents at least 12 years old can also participate.
  • Participants must have a diagnosis of severe Alopecia Areata (AA), which is a condition causing hair loss.
  • Participants should have a Severity of Alopecia Tool (SALT) score of 50 or more, indicating significant scalp hair loss, at both the start of the study and during the initial screening.
  • Participants should not have experienced any spontaneous regrowth of scalp hair in the past 6 months.
  • Participants should not have had any significant scalp hair loss in the past 3 months.
  • The current episode of Alopecia Areata (AA) must have lasted less than 8 years.

Who Cannot Join the Study?

  • Patients who have any other medical condition that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of allergic reactions to the study medication.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a serious infection or illness.
  • Patients who have a history of cancer.
  • Patients who have a weakened immune system.
  • Patients who are taking medications that might interfere with the study.
  • Patients who have had a recent surgery or are planning to have surgery during the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
KBC Zagreb Zagreb Croatia
Centre Hospitalier Universitaire Rouen Rouen France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Centre Hospitalier Universitaire De Toulouse Toulouse France
Karolinska University Hospital Solna Sweden
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Azienda USL Toscana Centro Florence Italy
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Centre Hospitalier Universitaire De Nice Nice France
Specijalna Bolnica Medico Rijeka Croatia
Poliklinika Solmed d.o.o. Zagreb Croatia
KBC Split Split Croatia
Universitair Ziekenhuis Gent Gent Belgium
Hospital Edouard Herriot Lyon France
University Hospital Bratislava Bratislava Slovakia
Hospital Cuf Descobertas S.A. Lisbon Portugal
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Centrum Medyczne All-Med Badania Kliniczne Cracow Poland
Centre D’Etude De La Peau Et Du Cheveu Paris France
Vrije Universiteit Brussel Jette Belgium
Universita Degli Studi Di Brescia Brescia Italy
Algemeen Ziekenhuis Delta Roeselare Belgium
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
CTC Clinical Trial Consultants AB Uppsala Sweden
University Of Pecs Pecs Hungary
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Charite Research Organisation GmbH Berlin Germany
Derma-B Kft. Debrecen Hungary
University Of Szeged Szeged Hungary
University Of Debrecen Debrecen Hungary
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
W-N Med Kft. Budapest Hungary
Hôpital Pontchaillou-CHU Rennes Rennes France
Westfaelische Wilhelms Universitaet Muenster Munster Germany
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov Presov Slovakia
Diagnostic-Consultative Center Alexandrovska EOOD Sofia Bulgaria
Courlancy Sante Reims France
Hospital Hotel Dieu Nantes France
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Elblag Poland
Klinika Osipowicz & Turkowski Sp. z o.o. Warsaw Poland
Derma therapy spol. s r.o. Bratislava Slovakia
Kaderma Majtan s.r.o. Topolcany Slovakia
Cgdemfyzk Udaafavdmuhchy Sznfgzjwn Woluwe-Saint-Lambert Belgium
Mcdxyzqa Lsgo Kecskemet Hungary
Djbxlairnswu Chvtsex Hdo i Saugrt Aa Stockholm Sweden
Cmuoxu Hwykjdkkqt Upkyryzvffuag Dp Pbfcg Ehxisq Porto Portugal
Ppgwglj Svm z orck Katowice Poland
Hmqtjprw Dx Lq Sdxpt Ccoe I Suqh Pxd Barcelona Spain
Cqndoux Bnitl Knwqpbqpgzd Pvelmbau Spq z osgg Gdansk Poland
Tvirkhrmxim uvz Szpmpwtkrxj Bjfdytqh Gaxc Bad Bentheim Germany
Agiutnq Sjksyqdbe Ljtxso Aticqhba Sajihte Lamtcqjycwiuoj L'aquila Italy
Mmmuuddnd Iwscdvhvmc Cpirpdgy Skfuybxj Sqq z owkd Warsaw Poland
Aahtuzk Uwtky Smxdeourb Lpunif Dl Byzdzpr Bologna Italy
Ujzvtolrpk Dttqc Scfqy Dz Rmvj Ln Slqurane Rome Italy
Fjllrldjt Pxtg Lu Iqxihcottergm Bzmgbcola Dgr Hmtjmccd Uigijggxpmisb Lq Pre Madrid Spain
Uftudzgffwslvyasgiiyf Dlicbhwueol Ahc Duesseldorf Germany
Bmilpxixtlr Vffqczcyt Ooplxapnuvya Kecskemet Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
05.02.2024
Bulgaria Bulgaria
Not recruiting
05.02.2024
Croatia Croatia
Not recruiting
05.02.2024
France France
Not recruiting
05.02.2024
Germany Germany
Not recruiting
05.02.2024
Greece Greece
Not recruiting
05.02.2024
Hungary Hungary
Not recruiting
05.02.2024
Italy Italy
Not recruiting
05.02.2024
Poland Poland
Not recruiting
05.02.2024
Portugal Portugal
Not recruiting
05.02.2024
Slovakia Slovakia
Not recruiting
05.02.2024
Spain Spain
Not recruiting
05.02.2024
Sweden Sweden
Not recruiting
05.02.2024

Trial locations

Investigated drugs:

Upadacitinib is a medication being studied for its effectiveness and safety in treating severe alopecia areata, a condition that causes hair loss. The trial involves adult and adolescent participants. The study aims to evaluate how well upadacitinib works in reducing the symptoms of alopecia areata and to monitor any side effects. Participants may receive different doses of upadacitinib during the trial to determine the most effective and safe dosage for long-term use.

Investigated diseases:

Alopecia Areata – Alopecia Areata is an autoimmune condition characterized by sudden hair loss in round patches on the scalp and other areas of the body. The immune system mistakenly attacks hair follicles, leading to hair loss. The progression of the disease can vary greatly among individuals, with some experiencing only a few small 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 recur. The exact cause of Alopecia Areata is not fully understood, but it is believed to involve a combination of genetic and environmental factors. The condition can affect people of all ages and genders.

Trial ID:
2023-505061-82-01
Protocol code:
M23-716
NCT ID:
NCT06012240
Trial Phase:
Therapeutic confirmatory (Phase III)

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