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RECRUITING

NCT06012240

PHASE3

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

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

12 Years - 63 Years

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2023-10-11

Completion Date

2030-04

Last Updated

2026-10-19

Healthy Volunteers

Conditions

Alopecia Areata

Interventions

DRUG

Upadacitinib

Oral Tablets

DRUG

Placebo

Oral Tablets

Locations (272)

Total Skin and Beauty Dermatology Center /ID# 259539

Birmingham, Alabama, United States

Duplicate_Advanced Research Associates - Glendale /ID# 259108

Glendale, Arizona, United States

Southwest Skin Specialists /ID# 258234

Phoenix, Arizona, United States

Alliance Dermatology and Mohs Center /ID# 258111

Phoenix, Arizona, United States

Johnson Dermatology Clinic /ID# 259103

Fort Smith, Arkansas, United States

Duplicate_JOSEPH RAOOF MD,INC /ID# 258031

Encino, California, United States

First Oc Dermatology /ID# 259220

Fountain Valley, California, United States

University of California Irvine /ID# 259096

Irvine, California, United States

Dermatology Research Associates /ID# 258033

Los Angeles, California, United States

Stanford University School of Medicine - Redwood City /ID# 259542

Redwood City, California, United States

Integrative Skin Science and Research /ID# 258114

Sacramento, California, United States

University of California Davis Health /ID# 258112

Sacramento, California, United States

Clinical Trials Research Institute /ID# 258021

Thousand Oaks, California, United States

Skin Care Research Boca Raton /ID# 258012

Boca Raton, Florida, United States

Apex Clinical Trials /ID# 259205

Brandon, Florida, United States

Florida Academic Dermatology Center /ID# 259353

Coral Gables, Florida, United States

Skin Research Institute LLC /ID# 259207

Coral Gables, Florida, United States

Revival Research /ID# 259213

Doral, Florida, United States

Skin Care Research - Hollywood /ID# 259210

Hollywood, Florida, United States

GSI Clinical Research, LLC /ID# 259352

Margate, Florida, United States

Life Clinical Trials - N State Rd - Margate /ID# 259358

Margate, Florida, United States

Lenus Research and Medical Group /ID# 259356

Miami, Florida, United States

International Clinical Research - Sanford /ID# 259547

Sanford, Florida, United States

FWD Clinical Research /ID# 266687

Tamarac, Florida, United States

Advanced Clinical Research Institute - Tampa /ID# 259204

Tampa, Florida, United States

Avita Clinical Research /ID# 258011

Tampa, Florida, United States

Cleaver Medical Group Dermatology /ID# 259801

Dawsonville, Georgia, United States

Marietta Dermatology /ID# 259818

Marietta, Georgia, United States

Northwestern Medicine - Northwestern Memorial Hospital /ID# 259555

Chicago, Illinois, United States

NorthShore University HealthSystem - Skokie /ID# 266684

Skokie, Illinois, United States

Indiana University Health University Hospital /ID# 259827

Indianapolis, Indiana, United States

U.S. Dermatology Partners Leawood /ID# 259203

Leawood, Kansas, United States

Tulane University School of Medicine /ID# 259799

New Orleans, Louisiana, United States

Raven Clinical Research /ID# 268453

Marriottsville, Maryland, United States

MetroBoston Clinical Partners /ID# 259559

Boston, Massachusetts, United States

Lahey Hospital and Medical Center /ID# 260484

Burlington, Massachusetts, United States

Great Lakes Research Group - Bay City /ID# 259100

Bay City, Michigan, United States

Derm Institute of West Michigan /ID# 259546

Caledonia, Michigan, United States

Hamzavi Dermatology - Canton /ID# 260115

Canton, Michigan, United States

Clarkston Dermatology /ID# 258018

Clarkston, Michigan, United States

Clinical Research Institute of Michigan /ID# 259802

Clinton Township, Michigan, United States

Henry Ford Medical Center - New Center One /ID# 258067

Detroit, Michigan, United States

M Health Fairview University of Minnesota Medical Center - East Bank /ID# 260122

Minneapolis, Minnesota, United States

Minnesota Clinical Study Center /ID# 259218

New Brighton, Minnesota, United States

Dermatology and Skin Center of Lees Summit /ID# 259206

Lee's Summit, Missouri, United States

Nebraska Dermatology /ID# 259354

Lincoln, Nebraska, United States

Skin Specialists /ID# 259237

Omaha, Nebraska, United States

Las Vegas Dermatology /ID# 279317

Las Vegas, Nevada, United States

Skin Cancer and Dermatology Institute - Reno /ID# 259208

Reno, Nevada, United States

The Skin Center Dermatology Group. /ID# 266748

New City, New York, United States

Schweiger Dermatology, P.C. /ID# 258007