Alopecia Areata Clinical Trial
— Up-AAOfficial 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
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
United States, Australia, Brazil, Canada, Chile, China, Japan, Korea, Republic of, New Zealand, Puerto Rico, United Kingdom,
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 |
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