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Janus Kinase (JAK) Inhibitor

Upadacitinib for Severe Alopecia Areata (Up-AA Trial)

Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current episode of AA of less than 8 years.
Diagnosis of severe AA with SALT score ≥ 50 scalp hair loss at Screening and Baseline.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights

Up-AA Trial Summary

This trial is testing how safe, effective, and tolerable the drug upadacitinib is for treating severe alopecia areata (hair loss). 1500 people will be enrolled in the trial at 240 sites worldwide.

Who is the study for?
Adults under 64 and adolescents at least 12 years old with severe alopecia areata (AA) can join this trial. They must have a SALT score ≥50 indicating significant scalp hair loss, no spontaneous hair regrowth in the past 6 months, and stable condition for the last 3 months. The current AA episode should be less than 8 years.Check my eligibility
What is being tested?
The study tests Upadacitinib's safety and effectiveness against severe AA compared to a placebo. Participants will take oral tablets daily for up to 160 weeks, with chances of being reassigned treatment based on their progress at specific intervals.See study design
What are the potential side effects?
While not specified here, common side effects of Upadacitinib may include infections, headaches, nausea, and potential increase in liver enzymes. Side effects vary by individual; all participants will be monitored regularly.

Up-AA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My current episode of alopecia areata has lasted less than 8 years.
Select...
I have severe alopecia areata with over 50% scalp hair loss.

Up-AA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20
Secondary outcome measures
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
Achievement of SALT score <= 20 for the Comparison of Upadacitinib Dose A QD Versus Placebo
Change from Baseline in AASIS Symptoms Subscale Score
+13 more

Up-AA Trial Design

17Treatment groups
Experimental Treatment
Group I: Study 3: Group 5 Upadacitinib Dose A (Sustained)Experimental Treatment1 Intervention
Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose A once daily for 108 weeks.
Group II: Study 3: Group 4 Upadacitinib Dose B (Sustained)Experimental Treatment1 Intervention
Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose B once daily for 108 weeks.
Group III: Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)Experimental Treatment1 Intervention
Participants who end Period B on upadacitinib Dose B with a with a SALT score > 20 at Week 40 or Week 52 of Study 1 or Study 2 will remain on upadacitinib Dose B once daily for 108 weeks.
Group IV: Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)Experimental Treatment1 Intervention
Participants receiving upadacitinib Dose A with a SALT score ≤ 20 at Week 52 (end of Period B) of Study 1 or Study 2 will remain on upadacitinib Dose A once daily for 108 weeks.
Group V: Study 3: Group 1 Upadacitinib Dose B (SALT > 20)Experimental Treatment1 Intervention
Participants receiving upadacitinib Dose A with a SALT score > 20 at Week 52 (end of Period B) of Study 1 or Study 2 will dose escalate to upadacitinib Dose B once daily for 108 weeks.
Group VI: Study 2: Group 6 PlaceboExperimental Treatment1 Intervention
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
Group VII: Study 2: Group 5 Upadacitinib Dose BExperimental Treatment2 Interventions
Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
Group VIII: Study 2: Group 4 Upadacitinib Dose AExperimental Treatment2 Interventions
Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
Group IX: Study 2: Group 3 PlaceboExperimental Treatment1 Intervention
Participants will receive matching placebo once daily for 24 weeks in Period A.
Group X: Study 2: Group 2 Upadacitinib Dose BExperimental Treatment1 Intervention
Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Group XI: Study 2: Group 1 Upadacitinib Dose AExperimental Treatment1 Intervention
Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Group XII: Study 1: Group 6 PlaceboExperimental Treatment1 Intervention
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.
Group XIII: Study 1: Group 5 Upadacitinib Dose BExperimental Treatment2 Interventions
Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.
Group XIV: Study 1: Group 4 Upadacitinib Dose AExperimental Treatment2 Interventions
Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.
Group XV: Study 1: Group 3 PlaceboExperimental Treatment1 Intervention
Participants will receive matching placebo once daily for 24 weeks in Period A.
Group XVI: Study 1: Group 2 Upadacitinib Dose BExperimental Treatment1 Intervention
Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.
Group XVII: Study 1: Group 1 Upadacitinib Dose AExperimental Treatment1 Intervention
Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Upadacitinib
2014
Completed Phase 3
~9670

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
500,890 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
145,609 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range for this experiment limited to individuals under 25 years old?

"According to the information provided, individuals between 12 and 63 years old are allowed to join this medical trial. There are also 16 clinical trials for minors and 62 studies available to those over 65 years of age."

Answered by AI

What are the associated risks of taking Upadacitinib Dose B in Study 3 Group 1 for individuals with SALT levels greater than 20?

"Due to Phase 3 trial results hinting at efficacy and a multitude of safety reports, our team assigned Study 3: Group 1 Upadacitinib Dose B (SALT > 20) the highest score possible on the risk scale–a three."

Answered by AI

Is recruitment for this experiment still ongoing?

"Affirmative, the records on clinicaltrials.gov illustrate that this medical trial is actively seeking participants. The study was first advertised on October 26th 2023 and has since been updated for public viewing on September 26th of the same year. A total of 1500 patients are being sought out from 3 distinct sites."

Answered by AI

Can I join this research endeavor?

"This trial seeks 1500 individuals aged between 12 and 63 suffering from alopecia areata, with the following prerequisites: Severe AA without spontaneous scalp regrowth in 6 months or significant hair loss over 3 months; adults of 64 years old or younger at baseline visit. Adolescents permitted outside US must be above 12 at screening; a SALT score ≥ 50 for scalp hair loss seen both during screening and baseline; an episode of less than 8 years' duration."

Answered by AI

How many participants have registered for this clinical investigation?

"Affirmative, according to clinicaltrials.gov this investigation is currently open for recruitment with a start date of October 26th 2023 and an update posted on September 26th 2023. In total 1500 patients need to be enrolled from three different medical sites."

Answered by AI

Who else is applying?

What site did they apply to?
Remington-Davis Clinical Research /ID# 258106
Skin Care Research - Boca Raton /ID# 258012
Integrative Skin Science and Research /ID# 258114
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I tried minoxidil and Finasteride and they did not work.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata
2023. "A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06012240.
All > Androgenetic Alopecia > Vancouver
~947 spots leftby May 2025
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