Comparing 23 approaches for alopecia areata
Official title: A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata
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
- Phase 3
- 23 groups
- Sites in Calgary, Edmonton and 13 more cities
- Recruiting
Interventions
- Medication
Upadacitinib
Oral Tablets
- Medication
Placebo
Oral Tablets
Canadian Sites (16)
16 listed, none recruiting
- Not currently recruiting
Dermatology Research Institute - Blackfoot Trail /ID# 258818
Calgary, Alberta
- Not currently recruiting
Beacon Dermatology /ID# 258817
Calgary, Alberta
- Not currently recruiting
Rejuvenation Dermatology - Edmonton Downtown /ID# 258816
Edmonton, Alberta
- Not currently recruiting
Dr. Chih-ho Hong Medical Inc. /ID# 258814
Surrey, British Columbia
- Not currently recruiting
Wiseman Dermatology Research /ID# 258819
Winnipeg, Manitoba
- Not currently recruiting
SimcoDerm Medical and Surgical Dermatology Center /ID# 258820
Barrie, Ontario
- Not currently recruiting
Medicor Research Inc /ID# 258810
Greater Sudbury, Ontario
- Not currently recruiting
Leader Research /ID# 267028
Hamilton, Ontario
- Not currently recruiting
Lynderm Research Inc /ID# 258815
Markham, Ontario
- Not currently recruiting
JRB Research /ID# 259248
Ottawa, Ontario
- Not currently recruiting
SKiN Centre for Dermatology /ID# 258813
Peterborough, Ontario
- Not currently recruiting
York Dermatology Clinic and Research Centre /ID# 267026
Richmond Hill, Ontario
- Not currently recruiting
Private Practice - Dr. Kim Papp Clinical Research /ID# 259249
Waterloo, Ontario
- Not currently recruiting
Innovaderm Research Inc. /ID# 258812
Montreal, Quebec
- Not currently recruiting
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 258811
Québec, Quebec
- Not currently recruiting
Private Practice - Dr. Angelique Gagne-Henley /ID# 267027
Saint-Jérôme, Quebec
Eligibility Criteria
See who this study is looking for7 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Adult individuals must be \< 64 years old at Baseline VisitBaselineYour starting measurements, taken before treatment begins.Read more →. Where permitted outside United States (US)/European Union (EU), adolescent individuals who are at least 12 years old at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 23 groups in this study.
Groups A, B, G, H, M, N, O, P, Q, R, S, U and V receive Upadacitinib.
Registry label: A: Study 1: Group 1 Upadacitinib Dose A · B: Study 1: Group 2 Upadacitinib Dose B · G: Study 2: Group 1 Upadacitinib Dose A · H: Study 2: Group 2 Upadacitinib Dose B · M: Study 3: Group 1 Upadacitinib Dose B (SALT > 20) · N: Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20) · O: Study 3: Group 3 Upadacitinib Dose B (Non-Sustained) · P: Study 3: Group 4 Upadacitinib Dose B (Sustained) · Q: Study 3: Group 5 Upadacitinib Dose A (Sustained) · R: Study 4: Group 1 Upadacitinib Dose A · S: Study 4: Group 2 Upadacitinib Dose B · U: Study 4: Group 4 Upadacitinib Dose A · V: Study 4: Group 5 Upadacitinib Dose B
Groups C, F, I, L, T and W receive PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
Registry label: C: Study 1: Group 3 Placebo · F: Study 1: Group 6 Placebo · I: Study 2: Group 3 Placebo · L: Study 2: Group 6 Placebo · T: Study 4: Group 3 Placebo · W: Study 4: Group 6 Placebo
Groups D, E, J and K receive Upadacitinib, together with one or more of: Placebo.
Registry label: D: Study 1: Group 4 Upadacitinib Dose A · E: Study 1: Group 5 Upadacitinib Dose B · J: Study 2: Group 4 Upadacitinib Dose A · K: Study 2: Group 5 Upadacitinib Dose B
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it — alongside the other treatment that group is given.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 12 years to 63 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,500 people.
The study is currently expected to finish around April 2030.
The main measurement is taken over: Week 24.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20 — measured over Week 24.
Number of Participants with Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Up to approximately 164 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06012240 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About UpadacitinibDrug
Oral Tablets
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Oral Tablets
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 12 years to 63 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it — alongside the other treatment that group is given.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 12 years to 63 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Week 24.
The study as a whole is currently expected to finish around 2030-04.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,500 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 27 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Surrey, British Columbia, Canada; Winnipeg, Manitoba, Canada; Barrie, Ontario, Canada; Greater Sudbury, Ontario, Canada, and 21 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (16)
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
Clin Res Inst of Michigan, LLC /ID# 259802
Chesterfield, Michigan, United States
Clarkston Dermatology /ID# 258018
Clarkston, Michigan, United States
Henry Ford Medical Center - New Center One /ID# 258067
Detroit, Michigan, United States
Dermatology Associates of West Michigan /ID# 283825
Grand Rapids, 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
The Skin Center Dermatology Group /ID# 266748
New City, New York, United States
Schweiger Dermatology, P.C. /ID# 258007
New York, New York, United States
Schweiger Dermatology, P.C. /ID# 259531
New York, New York, United States
Equity Medical /ID# 266680
New York, New York, United States
Icahn School of Medicine at Mount Sinai /ID# 259808
New York, New York, United States
Sadick Research Group LLC /ID# 266790
New York, New York, United States
Dermatology Specialists of Spokane /ID# 278362
Spokane, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.