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Taking people in United StatesPhase 3

Upadacitinib tablets for teenagers and adults with severe alopecia areata

Tests upadacitinib against placebo in adolescents and adults with severe alopecia areata.

Key facts

Who runs it
AbbVie
Where
Arlington, Bay City, Bellaire, Birmingham, Boca Raton, Boston, Brandon, Burlington, Caledonia, Canton, Cedar Park, Charleston, Chicago, Clarkston, Cleveland, Clinton Township, Columbus, Coral Gables, Dallas, Dawsonville, Detroit, Doral, Encino, Fort Smith, Fountain Valley, Glendale, Hollywood, Houston, Huntersville, Indianapolis, Irvine, Las Vegas, Leawood, Lee's Summit, Lincoln, Los Angeles, Margate, Marietta, Marriottsville, Mason, Miami, Minneapolis, Morgantown, Murfreesboro, New Brighton, New City, New Orleans, New York, Omaha, Phoenix, Pittsburgh, Portland, Rapid City, Redwood City, Reno, Sacramento, San Antonio, Sanford, Skokie, Spartanburg, Spokane, Springfield, Sugar Land, Tamarac, Tampa, and Thousand Oaks, United StatesSee the 78 sitesAlso in 27 other countries, 191 sites
Registry title
A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata
Status
Recruiting
Phase
Phase 3
People taking part
1,500 people, planned
Started
11 Oct 2023
Expected to end
Apr 2030
Type of study
Interventional, 23 groups
Treatments tested
  • Upadacitinib
  • Placebo
Record updated
19 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults and adolescents with severe alopecia areata, a disease where the immune system attacks hair roots and causes hair loss.

Age
Adults must be under 64 years old at the Baseline Visit. Adolescents at least 12 years old at Screening can join Study 1 and Study 2 where permitted outside the US/EU, and Study 4 in the US.
Sex
All sexes can join.
Disease stage
Severe alopecia areata with a SALT score >= 50 scalp hair loss at Screening and Baseline. No hair regrowing on its own over the past 6 months. The current episode has lasted less than 8 years.

Main reasons for not taking part

  • Mainly diffuse type of alopecia areata, where hair thins evenly across the scalp
  • Other types of hair loss that would make it hard to assess alopecia areata, such as female or male pattern hair loss (Stage III or greater), traction alopecia or trichotillomania
  • Scarring hair loss conditions such as lichen planopilaris, discoid lupus, frontal fibrosing alopecia or CCCA
  • Other inflammatory scalp, eyebrow or eyelash conditions, such as seborrheic dermatitis, scalp psoriasis, atopic dermatitis or tinea capitis

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Adult individuals must be < 64 years old at Baseline Visit. Where permitted outside United States (US)/European Union (EU), adolescent individuals who are at least 12 years old at Screening may participate in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4
  • Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score >= 50 scalp hair loss at Screening and Baseline
  • Severe AA with no spontaneous scalp hair regrowth over the past 6 months
  • Current episode of AA of less than 8 years

Who cannot take part

  • Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis
  • Current diagnosis of primarily diffuse type of AA
  • Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 12 and 63 years old?

Where in United States

Also in 27 other countries, 191 sites

  • Arlington Research Center, Inc /ID# 258028Arlington, United StatesTaking people
  • Great Lakes Research Group - Bay City /ID# 259100Bay City, United StatesNo longer taking part
  • Bellaire Dermatology Associates /ID# 259360Bellaire, United StatesTaking people
  • Total Skin and Beauty Dermatology Center /ID# 259539Birmingham, United StatesNo longer taking part
  • Skin Care Research Boca Raton /ID# 258012Boca Raton, United StatesContact: Site CoordinatorTaking people
  • MetroBoston Clinical Partners /ID# 259559Boston, United StatesNo longer taking part
  • Apex Clinical Trials /ID# 259205Brandon, United StatesNo longer taking part
  • Lahey Hospital and Medical Center /ID# 260484Burlington, United StatesNo longer taking part
  • Derm Institute of West Michigan /ID# 259546Caledonia, United StatesContact: Site CoordinatorTaking people
  • Hamzavi Dermatology - Canton /ID# 260115Canton, United StatesNo longer taking part
  • U.S. Dermatology Partners - Cedar Park /ID# 259367Cedar Park, United StatesContact: Site CoordinatorTaking people
  • Medical University of South Carolina /ID# 259828Charleston, United StatesNo longer taking part
  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 259555Chicago, United StatesNo longer taking part
  • Clarkston Dermatology /ID# 258018Clarkston, United StatesTaking people
  • Cleveland Clinic - Cleveland /ID# 258113Cleveland, United StatesTaking people
  • Clinical Research Institute of Michigan /ID# 259802Clinton Township, United StatesNo longer taking part
  • Remington-Davis Clinical Research /ID# 258106Columbus, United StatesNo longer taking part
  • Florida Academic Dermatology Center /ID# 259353Coral Gables, United StatesNo longer taking part
  • Skin Research Institute LLC /ID# 259207Coral Gables, United StatesNo longer taking part
  • Dermatology Treatment and Research Center /ID# 259357Dallas, United StatesTaking people
  • Modern Research Associates /ID# 259349Dallas, United StatesNo longer taking part
  • Reveal Research Institute - Dallas /ID# 259361Dallas, United StatesNo longer taking part
  • Cleaver Medical Group Dermatology /ID# 259801Dawsonville, United StatesNo longer taking part
  • Henry Ford Medical Center - New Center One /ID# 258067Detroit, United StatesNo longer taking part
  • Revival Research /ID# 259213Doral, United StatesNo longer taking part
  • Duplicate_JOSEPH RAOOF MD,INC /ID# 258031Encino, United StatesNo longer taking part
  • Johnson Dermatology Clinic /ID# 259103Fort Smith, United StatesNo longer taking part
  • First Oc Dermatology /ID# 259220Fountain Valley, United StatesTaking people
  • Duplicate_Advanced Research Associates - Glendale /ID# 259108Glendale, United StatesNo longer taking part
  • Skin Care Research - Hollywood /ID# 259210Hollywood, United StatesContact: Site CoordinatorTaking people
  • Center for Clinical Studies - Houston - Northwest Freeway /ID# 258036Houston, United StatesNo longer taking part
  • Piedmont Plastic Surgery and Dermatology - Huntersville /ID# 258206Huntersville, United StatesNo longer taking part
  • Indiana University Health University Hospital /ID# 259827Indianapolis, United StatesTaking people
  • University of California Irvine /ID# 259096Irvine, United StatesNo longer taking part
  • Las Vegas Dermatology /ID# 279317Las Vegas, United StatesContact: Site CoordinatorTaking people
  • U.S. Dermatology Partners Leawood /ID# 259203Leawood, United StatesNo longer taking part
  • Dermatology and Skin Center of Lees Summit /ID# 259206Lee's Summit, United StatesNo longer taking part
  • Nebraska Dermatology /ID# 259354Lincoln, United StatesNo longer taking part
  • Dermatology Research Associates /ID# 258033Los Angeles, United StatesTaking people
  • GSI Clinical Research, LLC /ID# 259352Margate, United StatesTaking people
  • Life Clinical Trials - N State Rd - Margate /ID# 259358Margate, United StatesNo longer taking part
  • Marietta Dermatology /ID# 259818Marietta, United StatesNo longer taking part
  • Raven Clinical Research /ID# 268453Marriottsville, United StatesNo longer taking part
  • Dermatologists of Southwest Ohio /ID# 260116Mason, United StatesContact: Site CoordinatorTaking people
  • Lenus Research and Medical Group /ID# 259356Miami, United StatesTaking people
  • M Health Fairview University of Minnesota Medical Center - East Bank /ID# 260122Minneapolis, United StatesNo longer taking part
  • West Virginia University Hospitals /ID# 278707Morgantown, United StatesTaking people
  • International Clinical Research - Tennessee LLC /ID# 259552Murfreesboro, United StatesTaking people
  • Minnesota Clinical Study Center /ID# 259218New Brighton, United StatesNo longer taking part
  • The Skin Center Dermatology Group. /ID# 266748New City, United StatesNo longer taking part
  • Tulane University School of Medicine /ID# 259799New Orleans, United StatesContact: Site CoordinatorTaking people
  • Equity Medical /ID# 266680New York, United StatesTaking people
  • Sadick Research Group LLC /ID# 266790New York, United StatesTaking people
  • Icahn School of Medicine at Mount Sinai /ID# 259808New York, United StatesNo longer taking part
  • Schweiger Dermatology, P.C. /ID# 258007New York, United StatesNo longer taking part
  • Schweiger Dermatology, P.C. /ID# 259531New York, United StatesNo longer taking part
  • Skin Specialists /ID# 259237Omaha, United StatesContact: Site CoordinatorTaking people
  • Alliance Dermatology and Mohs Center /ID# 258111Phoenix, United StatesNo longer taking part
  • Southwest Skin Specialists /ID# 258234Phoenix, United StatesNo longer taking part
  • University of Pittsburgh Medical Center /ID# 266681Pittsburgh, United StatesNo longer taking part
  • Oregon Dermatology and Research Center /ID# 258243Portland, United StatesTaking people
  • Oregon Medical Research Center /ID# 258107Portland, United StatesNo longer taking part
  • Health Concepts /ID# 266678Rapid City, United StatesNo longer taking part
  • Stanford University School of Medicine - Redwood City /ID# 259542Redwood City, United StatesNo longer taking part
  • Skin Cancer and Dermatology Institute - Reno /ID# 259208Reno, United StatesContact: Site CoordinatorTaking people
  • Integrative Skin Science and Research /ID# 258114Sacramento, United StatesTaking people
  • University of California Davis Health /ID# 258112Sacramento, United StatesContact: Site CoordinatorTaking people
  • Progressive Clinical Research /ID# 259365San Antonio, United StatesNo longer taking part
  • International Clinical Research - Sanford /ID# 259547Sanford, United StatesNo longer taking part
  • NorthShore University HealthSystem - Skokie /ID# 266684Skokie, United StatesNo longer taking part
  • Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 278359Spartanburg, United StatesContact: Site CoordinatorTaking people
  • Dermatology Specialists of Spokane /ID# 278362Spokane, United StatesTaking people
  • Dermatologist of Central States (DOCS) Clinical Research - Springfield /ID# 266746Springfield, United StatesNo longer taking part
  • Complete Dermatology /ID# 258025Sugar Land, United StatesNo longer taking part
  • FWD Clinical Research /ID# 266687Tamarac, United StatesNo longer taking part
  • Advanced Clinical Research Institute - Tampa /ID# 259204Tampa, United StatesContact: Site CoordinatorTaking people
  • Avita Clinical Research /ID# 258011Tampa, United StatesNo longer taking part
  • Clinical Trials Research Institute /ID# 258021Thousand Oaks, United StatesTaking people

About the trial

What the trial wants to find out

Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA.

Read full original descriptionShow less

Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 and Study 4 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1, Study 2 or Study 4, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 280 sites worldwide.

Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

The 23 groups in the trial

  • Study 1: Group 1 Upadacitinib Dose ATreatment being tested

    Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.

    Treatment: Upadacitinib

  • Study 1: Group 2 Upadacitinib Dose BTreatment being tested

    Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.

    Treatment: Upadacitinib

  • Study 1: Group 3 PlaceboTreatment being tested

    Participants will receive matching placebo once daily for 24 weeks in Period A.

    Treatment: Placebo

  • Study 1: Group 4 Upadacitinib Dose ATreatment being tested

    Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.

    Treatment: Upadacitinib and Placebo

  • Study 1: Group 5 Upadacitinib Dose BTreatment being tested

    Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.

    Treatment: Upadacitinib and Placebo

  • Study 1: Group 6 PlaceboTreatment being tested

    Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.

    Treatment: Placebo

  • Study 2: Group 1 Upadacitinib Dose ATreatment being tested

    Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.

    Treatment: Upadacitinib

  • Study 2: Group 2 Upadacitinib Dose BTreatment being tested

    Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.

    Treatment: Upadacitinib

  • Study 2: Group 3 PlaceboTreatment being tested

    Participants will receive matching placebo once daily for 24 weeks in Period A.

    Treatment: Placebo

  • Study 2: Group 4 Upadacitinib Dose ATreatment being tested

    Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.

    Treatment: Upadacitinib and Placebo

  • Study 2: Group 5 Upadacitinib Dose BTreatment being tested

    Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.

    Treatment: Upadacitinib and Placebo

  • Study 2: Group 6 PlaceboTreatment being tested

    Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.

    Treatment: Placebo

  • Study 3: Group 1 Upadacitinib Dose B (SALT > 20)Treatment being tested

    Participants receiving upadacitinib Dose A with a SALT score \> 20 at Week 52 (end of Period B) of Study 1 or Study 2 will dose escalate to upadacitinib Dose B once daily for 108 weeks.

    Treatment: Upadacitinib

  • Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)Treatment being tested

    Participants receiving upadacitinib Dose A with a SALT score ≤ 20 at Week 52 (end of Period B) of Study 1 or Study 2 will remain on upadacitinib Dose A once daily for 108 weeks.

    Treatment: Upadacitinib

  • Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)Treatment being tested

    Participants who end Period B on upadacitinib Dose B with a with a SALT score \> 20 at Week 40 or Week 52 of Study 1 or Study 2 will remain on upadacitinib Dose B once daily for 108 weeks.

    Treatment: Upadacitinib

  • Study 3: Group 4 Upadacitinib Dose B (Sustained)Treatment being tested

    Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose B once daily for 108 weeks.

    Treatment: Upadacitinib

  • Study 3: Group 5 Upadacitinib Dose A (Sustained)Treatment being tested

    Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose A once daily for 108 weeks.

    Treatment: Upadacitinib

  • Study 4: Group 1 Upadacitinib Dose ATreatment being tested

    US only adolescent participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.

    Treatment: Upadacitinib

  • Study 4: Group 2 Upadacitinib Dose BTreatment being tested

    US only adolescent participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.

    Treatment: Upadacitinib

  • Study 4: Group 3 PlaceboTreatment being tested

    US only adolescent participants will receive matching placebo once daily for 24 weeks in Period A.

    Treatment: Placebo

  • Study 4: Group 4 Upadacitinib Dose ATreatment being tested

    Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.

    Treatment: Upadacitinib

  • Study 4: Group 5 Upadacitinib Dose BTreatment being tested

    Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.

    Treatment: Upadacitinib

  • Study 4: Group 6 PlaceboTreatment being tested

    Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.

    Treatment: Placebo

Results explained

A paper that names this trial, explained in plain words.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata
Plain-language title
Upadacitinib tablets for teenagers and adults with severe alopecia areataGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06012240, who can take part
Publications
Record updated
19 October 2026