What side effects are associated with this type of intervention?

Common treatments for Alopecia Areata include JAK inhibitors like Upadacitinib and Tofacitinib. Known side effects of JAK inhibitors can include increased risk of infections, elevated liver enzymes, and gastrointestinal issues such as nausea and diarrhea. Other treatments like Methotrexate and Cyclosporine also have significant side effects, including liver toxicity, bone marrow suppression, and increased risk of infections. Topical treatments like corticosteroids may cause skin thinning and irritation.

What prior FDA approvals exist?

As of now, the FDA has approved baricitinib, a Janus Kinase (JAK) inhibitor, for the treatment of severe alopecia areata. Baricitinib works by modulating the immune response, which is beneficial in conditions like alopecia areata where the immune system attacks hair follicles. Other JAK inhibitors, such as tofacitinib, have shown promise in clinical studies but are not yet FDA-approved specifically for alopecia areata. Upadacitinib, another JAK inhibitor, is currently being studied for its safety and effectiveness in treating severe alopecia areata.

What other types of research exist?

Promising novel alternatives to Upadacitinib for Alopecia Areata patients include: 1) Tofacitinib: Shown improvement in SALT scores in both adults and children with AA, including cases refractory to corticosteroids. 2) Dupilumab: Demonstrated potential benefits in a phase 2 trial, with some patients achieving significant improvement in SALT scores after extended treatment. These alternatives are worth discussing with a healthcare provider for potential inclusion in treatment plans.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 164 weeks

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

0 / 5Eligibility criteria met

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?