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A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

AbbVie · NCT06012240

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12–63 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1500
US sites recruiting
30
Study start
October 11, 2023
Record last updated
October 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

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.

Being studied: Upadacitinib; Placebo

Conditions: Alopecia Areata

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
  • 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.

Recruiting US locations

  • First Oc Dermatology /ID# 259220

    Fountain Valley, CA 92708

  • Dermatology Research Associates /ID# 258033

    Los Angeles, CA 90045

  • Integrative Skin Science and Research /ID# 258114

    Sacramento, CA 95815

  • University of California Davis Health /ID# 258112

    Sacramento, CA 95817

    Site contact: Site Coordinator · 916-551-2635

  • Clinical Trials Research Institute /ID# 258021

    Thousand Oaks, CA 91320-2130

  • Skin Care Research Boca Raton /ID# 258012

    Boca Raton, FL 33486-2269

    Site contact: Site Coordinator · +1-561-948-3116

  • Skin Care Research - Hollywood /ID# 259210

    Hollywood, FL 33021-6748

    Site contact: Site Coordinator · +1-561-948-3116

  • GSI Clinical Research, LLC /ID# 259352

    Margate, FL 33063

  • Lenus Research and Medical Group /ID# 259356

    Miami, FL 33172

  • Advanced Clinical Research Institute - Tampa /ID# 259204

    Tampa, FL 33607

    Site contact: Site Coordinator · 1-813-362-1037

  • Indiana University Health University Hospital /ID# 259827

    Indianapolis, IN 46202

  • Tulane University School of Medicine /ID# 259799

    New Orleans, LA 70112

    Site contact: Site Coordinator · 504-988-5135

  • Derm Institute of West Michigan /ID# 259546

    Caledonia, MI 49316-7478

    Site contact: Site Coordinator · 616-512-4445

  • Clarkston Dermatology /ID# 258018

    Clarkston, MI 48346

  • Skin Specialists /ID# 259237

    Omaha, NE 68144

    Site contact: Site Coordinator · 402-697-6599

  • Las Vegas Dermatology /ID# 279317

    Las Vegas, NV 89144

    Site contact: Site Coordinator · 702 456 3120

  • Skin Cancer and Dermatology Institute - Reno /ID# 259208

    Reno, NV 89509

    Site contact: Site Coordinator · 775-336-3665

  • Equity Medical /ID# 266680

    New York, NY 10023-7340

  • Sadick Research Group LLC /ID# 266790

    New York, NY 10075

  • Cleveland Clinic - Cleveland /ID# 258113

    Cleveland, OH 44195

  • Dermatologists of Southwest Ohio /ID# 260116

    Mason, OH 45040-4520

    Site contact: Site Coordinator · 513-701-5526

  • Oregon Dermatology and Research Center /ID# 258243

    Portland, OR 97210

  • Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 278359

    Spartanburg, SC 29307

    Site contact: Site Coordinator · 864 574-0017 ext 8

  • International Clinical Research - Tennessee LLC /ID# 259552

    Murfreesboro, TN 37130-2450

  • Arlington Research Center, Inc /ID# 258028

    Arlington, TX 76011

  • Bellaire Dermatology Associates /ID# 259360

    Bellaire, TX 77401

  • U.S. Dermatology Partners - Cedar Park /ID# 259367

    Cedar Park, TX 78613

    Site contact: Site Coordinator · 512-260-5860

  • Dermatology Treatment and Research Center /ID# 259357

    Dallas, TX 75230

  • Dermatology Specialists of Spokane /ID# 278362

    Spokane, WA 99202

  • West Virginia University Hospitals /ID# 278707

    Morgantown, WV 26506

Study contacts (from the official record)

  • ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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A Study to Evaluate the Safety and Effectiveness of Upadacitinib… (NCT06012240) | Bored Studies