Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

10 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

Upadacitinib – Upadacitinib is administered orally in tablet form, typically taken once daily. It is currently being studied in clinical trials for its effectiveness and safety in treating severe Alopecia Areata, a condition characterized by sudden hair loss. The medication works by inhibiting Janus kinase (JAK) enzymes, which play a role in the inflammatory process that contributes to hair loss. Upadacitinib is classified as a JAK inhibitor and is being evaluated for its potential to improve hair regrowth and reduce symptoms in affected individuals.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505061-82-01Protocol codeM23-716Estimated enrolment1 529 patientsSponsorAbbVie Deutschland GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.