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

Alopecia Areata Clinical Trial

— Up-AA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06012240
• Other study ID #: M23-716
• Secondary ID: 2023-505061-82-0
• Status: Recruiting
• Phase: Phase 3
• Start date: October 11, 2023
• Est. completion date: January 3, 2028

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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 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 or Study 2, 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 240 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: January 3, 2028
• Est. primary completion date: May 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 63 Years

Eligibility

Inclusion Criteria:

• Adult individuals must be < 64 years old at Baseline Visit. Where permitted outside United States (OUS), adolescent individuals who are at least 12 years old at Screening may participate.

• 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 AND no significant scalp hair loss over the past 3 months.

• Current episode of AA of less than 8 years.

Exclusion Criteria:

• Diagnosis of primarily diffuse type of AA.

• 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, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Upadacitinib
Oral Tablets
• Placebo
Oral Tablets

Locations

Country	Name	City	State
Australia	Skin Health Institute Inc /ID# 258570	Carlton	Victoria
Australia	Cornerstone Dermatology /ID# 258769	Coorparoo	Queensland
Australia	Holdsworth House Medical Practice /ID# 258571	Darlinghurst	New South Wales
Australia	Sinclair Dermatology - Melbourne /ID# 258565	East Melbourne	Victoria
Australia	Fremantle Dermatology /ID# 260207	Fremantle	Western Australia
Australia	St George Dermatology & Skin Cancer Centre /ID# 258567	Kogarah	New South Wales
Australia	The Royal Melbourne Hospital /ID# 258770	Parkville	Victoria
Australia	Veracity Clinical Research /ID# 258566	Woolloongabba	Queensland
Brazil	Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 258045	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto Brasil de Pesquisa Clinica S.A - IBPClin /ID# 258750	Rio de Janeiro
Brazil	Hospital Alemao Oswaldo Cruz /ID# 258104	Sao Paulo
Canada	SimcoDerm Medical and Surgical Dermatology Center /ID# 258820	Barrie	Ontario
Canada	Lynde Institute for Dermatology /ID# 258815	Markham	Ontario
Canada	Innovaderm Research Inc. /ID# 258812	Montréal	Quebec
Canada	JRB Research /ID# 259248	Ottawa	Ontario
Canada	SKiN Centre for Dermatology /ID# 258813	Peterborough	Ontario
Canada	Centre de Recherche dermatologique du Quebec Metropolitain /ID# 258811	Québec	Quebec
Canada	Dr. Chih-ho Hong Medical Inc. /ID# 258814	Surrey	British Columbia
Canada	Private Practice - Dr. Kim Papp Clinical Research /ID# 259249	Waterloo	Ontario
Canada	Wiseman Dermatology Research /ID# 258819	Winnipeg	Manitoba
Chile	Clinica Dermacross /ID# 259311	Santiago
China	China-Japan Friendship Hospital /ID# 258941	Beijing	Beijing
China	The First Hospital of Jilin University /ID# 257496	Changchun	Jilin
China	Chengdu Second Municipal People's Hospital /ID# 259492	Chengdu	Sichuan
China	West China Hospital, Sichuan University /ID# 259560	Chengdu	Sichuan
China	The Second Affiliated Hospital of Chongqing Medical University /ID# 260254	Chongqing
China	Dermatology Hospital of Southern Medical University /ID# 257118	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University /ID# 258663	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University /ID# 257367	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 257119	Hangzhou	Zhejiang
China	Dermatology Hospital of Jiangxi Provincial /ID# 259488	Nanchang	Jiangxi
China	Huashan Hospital, Fudan University /ID# 257758	Shanghai	Shanghai
China	Shenzhen People's Hospital /ID# 258208	Shenzhen	Guangdong
China	Shenzhen Second People's Hospital /ID# 258060	Shenzhen	Guangdong
China	First Affiliated Hospital of Shanxi Medical University /ID# 259647	Taiyuan	Shanxi
China	Tianjin Medical University General Hospital /ID# 259525	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University /ID# 257739	Wenzhou	Zhejiang
Japan	Hamamatsu University Hospital /ID# 257253	Hamamatsu-shi	Shizuoka
Japan	Kurume University Hospital /ID# 257255	Kurume-shi	Fukuoka
Japan	Kyorin University - Mitaka Campus /ID# 257283	Mitaka
Japan	Niigata University Medical & Dental Hospital /ID# 259425	Niigata-shi	Niigata
Japan	Osaka Metropolitan University Hospital /ID# 257256	Osaka-shi	Osaka
Japan	Kitasato University Hospital /ID# 257285	Sagamihara-shi	Kanagawa
Japan	Tokyo Medical University Hospital /ID# 258132	Shinjuku-ku	Tokyo
Japan	Yamaguchi University Hospital /ID# 257252	Ube-shi	Yamaguchi
Korea, Republic of	Seoul National University Hospital /ID# 257903	Seoul
New Zealand	Aotearoa Clinical Trials /ID# 258562	Auckland
New Zealand	Greenlane Clinical Centre /ID# 258563	Epsom	Auckland
New Zealand	Clinical Trials New Zealand /ID# 258564	Hamilton
New Zealand	P3 Research Ltd /ID# 259846	Wellington
Puerto Rico	Santa Cruz Behavioral (SCB) Research Center /ID# 259350	Bayamon
Puerto Rico	Dr. Samuel Sanchez PSC /ID# 259359	Caguas
Puerto Rico	Clinical Research Puerto Rico /ID# 259355	San Juan
Puerto Rico	GCM Medical Group PSC /ID# 258013	San Juan
Puerto Rico	Mindful Medical Research /ID# 260113	San Juan
United Kingdom	Gloucestershire Royal Hospital /ID# 257953	Gloucester
United Kingdom	London North West University Healthcare NHS Trust /ID# 257914	Harrow
United Kingdom	Velocity Clinical Research Ltd /ID# 257925	High Wycombe	Buckinghamshire
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust /ID# 259128	London
United Kingdom	Oxford University Hospitals NHS Foundation Trust /ID# 257948	Oxford	Oxfordshire
United Kingdom	Northern Care Alliance NHS Group /ID# 257952	Salford
United Kingdom	University Hospitals Sussex NHS Foundation Trust /ID# 257912	Worthing	West Sussex
United States	Arlington Research Center, Inc /ID# 258028	Arlington	Texas
United States	Great Lakes Research Group - Bay City /ID# 259100	Bay City	Michigan
United States	Bellaire Dermatology Associates /ID# 259360	Bellaire	Texas
United States	Total Skin and Beauty Dermatology Center /ID# 259539	Birmingham	Alabama
United States	Skin Care Research Boca Raton /ID# 258012	Boca Raton	Florida
United States	MetroBoston Clinical Partners /ID# 259559	Boston	Massachusetts
United States	Apex Clinical Trials /ID# 259205	Brandon	Florida
United States	Lahey Hospital & Medical Center /ID# 260484	Burlington	Massachusetts
United States	Hamzavi Dermatology - Canton /ID# 260115	Canton	Michigan
United States	U.S. Dermatology Partners - Cedar Park /ID# 259367	Cedar Park	Texas
United States	Medical University of South Carolina /ID# 259828	Charleston	South Carolina
United States	Clin Res Inst of Michigan, LLC /ID# 259802	Chesterfield	Michigan
United States	Clarkston Dermatology /ID# 258018	Clarkston	Michigan
United States	Remington-Davis Clinical Research /ID# 258106	Columbus	Ohio
United States	Florida Academic Dermatology Center /ID# 259353	Coral Gables	Florida
United States	Dermatology Treatment and Research Center /ID# 259357	Dallas	Texas
United States	Modern Research Associates, PLLC /ID# 259349	Dallas	Texas
United States	Reveal Research Institute, Dallas /ID# 259361	Dallas	Texas
United States	Cleaver Medical Group Dermatology /ID# 259801	Dawsonville	Georgia
United States	Henry Ford Medical Center - New Center One /ID# 258067	Detroit	Michigan
United States	Revival Research /ID# 259213	Doral	Florida
United States	Joseph Raoof Md,Inc /Id# 258031	Encino	California
United States	Johnson Dermatology Clinic /ID# 259103	Fort Smith	Arkansas
United States	First OC Dermatology /ID# 259220	Fountain Valley	California
United States	Advanced Research Associates - Glendale /ID# 259108	Glendale	Arizona
United States	Skin Care Research - Hollywood /ID# 259210	Hollywood	Florida
United States	Center for Clinical Studies - Houston - Northwest Freeway /ID# 258036	Houston	Texas
United States	University of California Irvine /ID# 259096	Irvine	California
United States	U.S. Dermatology Partners Leawood /ID# 259203	Leawood	Kansas
United States	Dermatology and Skin Center of Lees Summit /ID# 259206	Lee's Summit	Missouri
United States	Physician Research Collaboration, LLC /ID# 259354	Lincoln	Nebraska
United States	Dermatology Research Associates /ID# 258033	Los Angeles	California
United States	GSI Clinical Research, LLC /ID# 259352	Margate	Florida
United States	Life Clinical Trials /ID# 259358	Margate	Florida
United States	Marietta Dermatology /ID# 259818	Marietta	Georgia
United States	Dermatologists of Southwest Ohio, Inc /ID# 260116	Mason	Ohio
United States	Lenus Research and Medical Group /ID# 259356	Miami	Florida
United States	International Clinical Research - Tennessee LLC /ID# 259552	Murfreesboro	Tennessee
United States	Minnesota Clinical Study Center /ID# 259218	New Brighton	Minnesota
United States	Icahn School of Medicine at Mount Sinai /ID# 259808	New York	New York
United States	Skin Specialists, PC /ID# 259237	Omaha	Nebraska
United States	Alliance Dermatology and MOHs Center, PC /ID# 258111	Phoenix	Arizona
United States	Southwest Skin Specialists /ID# 258234	Phoenix	Arizona
United States	Oregon Dermatology and Research Center /ID# 258243	Portland	Oregon
United States	Oregon Medical Research Center /ID# 258107	Portland	Oregon
United States	Skin Cancer and Dermatology Institute - Reno /ID# 259208	Reno	Nevada
United States	Integrative Skin Science and Research /ID# 258114	Sacramento	California
United States	University of California Davis Health /ID# 258112	Sacramento	California
United States	Progressive Clinical Research /ID# 259365	San Antonio	Texas
United States	International Clinical Research - Sanford /ID# 259547	Sanford	Florida
United States	Complete Dermatology /ID# 258025	Sugar Land	Texas
United States	Advanced Clinical Research Institute /ID# 259204	Tampa	Florida
United States	Avita Clinical Research /ID# 258011	Tampa	Florida
United States	Clinical Trials Research Institute /ID# 258021	Thousand Oaks	California
United States	Schweiger Dermatology, P.C. /ID# 258007	Verona	New York
United States	Schweiger Dermatology, P.C. /ID# 259531	Verona	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Chile,  China,  Japan,  Korea, Republic of,  New Zealand,  Puerto Rico,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20	The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.	Week 24
Secondary	Achievement of SALT score <= 20 for the Comparison of Upadacitinib Dose A QD Versus Placebo	The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.	Week 24
Secondary	Percentage of Participants with the Achievement of SALT Score <= 10	The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.	Week 24
Secondary	Percentage of Participants with the Achievement of SALT Score <= 20	The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.	Up to Week 12
Secondary	Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1	The ClinRO for Eyebrow Hair Loss is a 4-point response scale where 0 = The eyebrows have full coverage and no areas of hair loss and 3 = No notable eyebrows. Responses should have a = 2-point improvement from Baseline among participants with Baseline score = 2.	Baseline to Week 24
Secondary	Percentage of Participants with the Achievement of ClinRO Measure for Eyelash Hair Loss of 0 or 1	The ClinRO for Eyebrow Hair Loss is a 4-point response scale where 0 = The eyelashes form a continuous line along the eyelids on both eyes and 3 = No notable eyelashes. Responses should have a = 2-point improvement from Baseline among participants with Baseline score = 2.	Baseline to Week 24
Secondary	Percentage of Participants with the Achievement of SALT 75	SALT 75 is defined as at least a 75% improvement [decrease] from Baseline in SALT score.	Baseline to Week 24
Secondary	Percentage of Participants with the Achievement of SALT 90	SALT 90 is defined as at least a 90% improvement [decrease] from Baseline in SALT score.	Baseline to Week 24
Secondary	Percent Change from Baseline in SALT Score	The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.	Baseline to Week 24
Secondary	Percentage of Participants with the Achievement of Patients' Global Impression of Change of Alopecia Areata (PaGIC-AA) Score of 1 "Much Better" or 2 "Moderately Better"	The PaGIC-AA is a single-item measure that asks participants to rate how their alopecia condition has changed overall since the start of the study using a 7-point scale. Responses range from "much better" to "much worse."	Up to Week 24
Secondary	Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment 0/1 with = 2-Point Improvement (Reduction)	The PRO for Scalp Hair Assessment is single item, five-point, categorical response scale that asks respondents to look in the mirror and assess the total area of the scalp with missing hair. Response items range from "No missing hair" to "Nearly all or all" and includes percentage ranges for each category (0%, 1 to 20%, 21 to 49%, 50 to 94%, and 95 to 100%). Responses among participants with baseline score >=3.	Baseline to Week 24
Secondary	Change from Baseline in Skindex-16 AA Emotions Domain Scores	The Skindex-16 AA Emotions Domain is a 7-item assessment ranging from 0 = never bothered to 6 = always bothered that measures the effects of AA on a subject's health-related quality of life. Higher scores indicate greater impact on health-related quality of life.	Week 24
Secondary	Change from Baseline in Skindex-16 AA Functioning Domain Scores	The Skindex-16 AA Emotions Domain is a 5-item assessment ranging from 0 = never bothered to 6 = always bothered, that measures the effects of AA on a subject's health-related quality of life. Higher scores indicate greater impact on health-related quality of life.	Week 24
Secondary	Change from Baseline in Alopecia Areata Symptom Impact Scale (AASIS) Interference Subscale Score	The AASIS Interference Subscale is a 6-item assessment with scores ranging from 0 = 'did not interfere' to 10 = 'interfered completely' with higher scores indicating greater symptom interference.	Week 24
Secondary	Change from Baseline in AASIS Symptoms Subscale Score	The AASIS Symptom Subscale is a 7-item assessment with scores ranging from 0 = 'not present' to 10 = 'as bad as you can imagine' with higher scores indicating greater symptom severity.	Week 24
Secondary	Achievement of Hospital Anxiety and Depression Scale (HADS)-Anxiety < 8 and HADS-Depression < 8 at Week 24 Among Participants with HADS-A >= 8 or HADS-D >= 8 at Baseline	The HADS is a self-administered scale which measures anxiety and depression. It contains 14 items and is comprised of anxiety (7 items) and depression (7 items) subscales, which are scored separately and summed to give a total score. Item scores range from 0 (best) to 3 (worst), and total scores are categorized as normal (0 to 7), borderline abnormal (8 to 10), and abnormal (11 to 21).	Baseline to Week 24
Secondary	Percentage of Participants with the Achievement of SALT Score 0	The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.	Week 24

External Links

•   Related Info