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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.
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 164 weeks
Awards & highlights
Pivotal Trial

Summary

This trial is testing upadacitinib, a medication that may help people with severe hair loss due to alopecia areata. The drug works by stopping the immune system from attacking hair roots. Adolescents and adults with severe alopecia areata are participating to see if this treatment is safe and effective.

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have other hair loss conditions that could affect the study.
Select...
I do not have scalp or eyelash conditions like psoriasis or dermatitis.
Select...
My diagnosis is primarily diffuse astrocytoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 164 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 164 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Adverse Events (AEs)
Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20
Secondary study objectives
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
Upadacitinib
2014
Completed Phase 3
~11250
Placebo
1995
Completed Phase 3
~2670

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Alopecia Areata (AA) is an autoimmune condition where the immune system attacks hair follicles, leading to hair loss. Janus Kinase (JAK) inhibitors, such as Upadacitinib, work by blocking the JAK-STAT signaling pathways, which are involved in the inflammatory processes that contribute to AA. By inhibiting these pathways, JAK inhibitors can reduce inflammation and potentially restore hair growth. Other treatments include immunosuppressants like methotrexate and cyclosporine, which also aim to reduce immune system activity, and topical therapies like minoxidil, which stimulate hair growth through different mechanisms. Understanding these mechanisms is crucial for AA patients as it helps in selecting the most appropriate treatment based on the disease's severity and individual response.
Case Report: Successful Treatment of Alopecia Universalis With Tofacitinib and Increased Cytokine Levels: Normal Therapeutic Reaction or Danger Signal?

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,022 Previous Clinical Trials
518,679 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
443 Previous Clinical Trials
159,165 Total Patients Enrolled
~1000 spots leftby Jan 2028