A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata
Public ClinicalTrials.gov record NCT06012240. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06012240
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,500 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 63 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 11, 2023 (Actual)
- Primary completion
- Apr 2030 (Estimated)
- Completion
- Apr 2030 (Estimated)
- Last update posted
- Oct 13, 2026
2023 – 2030
United States locations
- U.S. sites
- 78
- U.S. states
- 28
- U.S. cities
- 66
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center /ID# 259539 | Birmingham | Alabama | 35205 | Active, not recruiting |
| Duplicate_Advanced Research Associates - Glendale /ID# 259108 | Glendale | Arizona | 85308 | Completed |
| Southwest Skin Specialists /ID# 258234 | Phoenix | Arizona | 85018-3953 | Completed |
| Alliance Dermatology and Mohs Center /ID# 258111 | Phoenix | Arizona | 85032 | Active, not recruiting |
| Johnson Dermatology Clinic /ID# 259103 | Fort Smith | Arkansas | 72916-6103 | Active, not recruiting |
| Duplicate_JOSEPH RAOOF MD,INC /ID# 258031 | Encino | California | 91436 | Completed |
| First Oc Dermatology /ID# 259220 | Fountain Valley | California | 92708 | Recruiting |
| University of California Irvine /ID# 259096 | Irvine | California | 92697-1385 | Active, not recruiting |
| Dermatology Research Associates /ID# 258033 | Los Angeles | California | 90045 | Recruiting |
| Stanford University School of Medicine - Redwood City /ID# 259542 | Redwood City | California | 94063 | Completed |
| Integrative Skin Science and Research /ID# 258114 | Sacramento | California | 95815 | Recruiting |
| University of California Davis Health /ID# 258112 | Sacramento | California | 95817 | Recruiting |
| Clinical Trials Research Institute /ID# 258021 | Thousand Oaks | California | 91320-2130 | Recruiting |
| Skin Care Research Boca Raton /ID# 258012 | Boca Raton | Florida | 33486-2269 | Recruiting |
| Apex Clinical Trials /ID# 259205 | Brandon | Florida | 33511 | Active, not recruiting |
| Florida Academic Dermatology Center /ID# 259353 | Coral Gables | Florida | 33134-5755 | Active, not recruiting |
| Skin Research Institute LLC /ID# 259207 | Coral Gables | Florida | 33146-1837 | Completed |
| Revival Research /ID# 259213 | Doral | Florida | 33122-1902 | Completed |
| Skin Care Research - Hollywood /ID# 259210 | Hollywood | Florida | 33021-6748 | Recruiting |
| GSI Clinical Research, LLC /ID# 259352 | Margate | Florida | 33063 | Recruiting |
| Life Clinical Trials - N State Rd - Margate /ID# 259358 | Margate | Florida | 33063 | Active, not recruiting |
| Lenus Research and Medical Group /ID# 259356 | Miami | Florida | 33172 | Recruiting |
| International Clinical Research - Sanford /ID# 259547 | Sanford | Florida | 32771 | Completed |
| FWD Clinical Research /ID# 266687 | Tamarac | Florida | 33321-2931 | Completed |
| Advanced Clinical Research Institute - Tampa /ID# 259204 | Tampa | Florida | 33607 | Recruiting |
| Avita Clinical Research /ID# 258011 | Tampa | Florida | 33613-1825 | Completed |
| Cleaver Medical Group Dermatology /ID# 259801 | Dawsonville | Georgia | 30534 | Active, not recruiting |
| Marietta Dermatology /ID# 259818 | Marietta | Georgia | 30060 | Active, not recruiting |
| Northwestern Medicine - Northwestern Memorial Hospital /ID# 259555 | Chicago | Illinois | 60611 | Completed |
| NorthShore University HealthSystem - Skokie /ID# 266684 | Skokie | Illinois | 60077 | Active, not recruiting |
| Indiana University Health University Hospital /ID# 259827 | Indianapolis | Indiana | 46202 | Recruiting |
| U.S. Dermatology Partners Leawood /ID# 259203 | Leawood | Kansas | 66211-1453 | Completed |
| Tulane University School of Medicine /ID# 259799 | New Orleans | Louisiana | 70112 | Recruiting |
| Raven Clinical Research /ID# 268453 | Marriottsville | Maryland | 21104 | Completed |
| MetroBoston Clinical Partners /ID# 259559 | Boston | Massachusetts | 02135-3511 | Active, not recruiting |
| Lahey Hospital and Medical Center /ID# 260484 | Burlington | Massachusetts | 01805 | Completed |
| Great Lakes Research Group - Bay City /ID# 259100 | Bay City | Michigan | 48706 | Completed |
| Derm Institute of West Michigan /ID# 259546 | Caledonia | Michigan | 49316-7478 | Recruiting |
| Hamzavi Dermatology - Canton /ID# 260115 | Canton | Michigan | 48187 | Completed |
| Clarkston Dermatology /ID# 258018 | Clarkston | Michigan | 48346 | Recruiting |
| Clinical Research Institute of Michigan /ID# 259802 | Clinton Township | Michigan | 48038 | Active, not recruiting |
| Henry Ford Medical Center - New Center One /ID# 258067 | Detroit | Michigan | 48202-3046 | Active, not recruiting |
| M Health Fairview University of Minnesota Medical Center - East Bank /ID# 260122 | Minneapolis | Minnesota | 55455 | Active, not recruiting |
| Minnesota Clinical Study Center /ID# 259218 | New Brighton | Minnesota | 55112 | Completed |
| Dermatology and Skin Center of Lees Summit /ID# 259206 | Lee's Summit | Missouri | 64064-2301 | Completed |
| Nebraska Dermatology /ID# 259354 | Lincoln | Nebraska | 68512 | Active, not recruiting |
| Skin Specialists /ID# 259237 | Omaha | Nebraska | 68144 | Recruiting |
| Las Vegas Dermatology /ID# 279317 | Las Vegas | Nevada | 89144 | Recruiting |
| Skin Cancer and Dermatology Institute - Reno /ID# 259208 | Reno | Nevada | 89509 | Recruiting |
| The Skin Center Dermatology Group. /ID# 266748 | New City | New York | 10956-7153 | Active, not recruiting |
| Schweiger Dermatology, P.C. /ID# 258007 | New York | New York | 07044-2946 | Completed |
| Schweiger Dermatology, P.C. /ID# 259531 | New York | New York | 07044-2946 | Completed |
| Equity Medical /ID# 266680 | New York | New York | 10023-7340 | Recruiting |
| Icahn School of Medicine at Mount Sinai /ID# 259808 | New York | New York | 10029 | Active, not recruiting |
| Sadick Research Group LLC /ID# 266790 | New York | New York | 10075 | Recruiting |
| Piedmont Plastic Surgery and Dermatology - Huntersville /ID# 258206 | Huntersville | North Carolina | 28078-7961 | Completed |
| Cleveland Clinic - Cleveland /ID# 258113 | Cleveland | Ohio | 44195 | Recruiting |
| Remington-Davis Clinical Research /ID# 258106 | Columbus | Ohio | 43215 | Active, not recruiting |
| Dermatologists of Southwest Ohio /ID# 260116 | Mason | Ohio | 45040-4520 | Recruiting |
| Dermatologist of Central States (DOCS) Clinical Research - Springfield /ID# 266746 | Springfield | Ohio | 45505 | Completed |
| Oregon Dermatology and Research Center /ID# 258243 | Portland | Oregon | 97210 | Recruiting |
| Oregon Medical Research Center /ID# 258107 | Portland | Oregon | 97223 | Active, not recruiting |
| University of Pittsburgh Medical Center /ID# 266681 | Pittsburgh | Pennsylvania | 15213 | Active, not recruiting |
| Medical University of South Carolina /ID# 259828 | Charleston | South Carolina | 29425 | Active, not recruiting |
| Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 278359 | Spartanburg | South Carolina | 29307 | Recruiting |
| Health Concepts /ID# 266678 | Rapid City | South Dakota | 57702 | Active, not recruiting |
| International Clinical Research - Tennessee LLC /ID# 259552 | Murfreesboro | Tennessee | 37130-2450 | Recruiting |
| Arlington Research Center, Inc /ID# 258028 | Arlington | Texas | 76011 | Recruiting |
| Bellaire Dermatology Associates /ID# 259360 | Bellaire | Texas | 77401 | Recruiting |
| U.S. Dermatology Partners - Cedar Park /ID# 259367 | Cedar Park | Texas | 78613 | Recruiting |
| Dermatology Treatment and Research Center /ID# 259357 | Dallas | Texas | 75230 | Recruiting |
| Modern Research Associates /ID# 259349 | Dallas | Texas | 75231 | Completed |
| Reveal Research Institute - Dallas /ID# 259361 | Dallas | Texas | 75235 | Completed |
| Center for Clinical Studies - Houston - Northwest Freeway /ID# 258036 | Houston | Texas | 77065 | Completed |
| Progressive Clinical Research /ID# 259365 | San Antonio | Texas | 78229 | Active, not recruiting |
| Complete Dermatology /ID# 258025 | Sugar Land | Texas | 77479-3794 | Active, not recruiting |
| Dermatology Specialists of Spokane /ID# 278362 | Spokane | Washington | 99202 | Recruiting |
| West Virginia University Hospitals /ID# 278707 | Morgantown | West Virginia | 26506 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 194 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06012240, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06012240 live on ClinicalTrials.gov.