What side effects are associated with this type of intervention?

Common treatments for Alopecia Areata, particularly JAK inhibitors like Baricitinib, can have several side effects. For Baricitinib, side effects include headache, increased blood levels of creatine phosphokinase, decreased neutrophil count, and nasopharyngitis. Other JAK inhibitors, such as tofacitinib, have been associated with mild infections, increased blood creatine phosphokinase, and contact dermatitis. Additionally, treatments like cyclosporine can cause serious adverse effects such as liver enzyme elevation, pancreatitis, and bone marrow suppression, which often preclude long-term use.

What prior FDA approvals exist?

As of now, the FDA has approved the use of Janus kinase (JAK) inhibitors for the treatment of Alopecia Areata. One notable JAK inhibitor is tofacitinib, which has shown efficacy in both adults and children with Alopecia Areata, Alopecia Totalis, and Alopecia Universalis. Tofacitinib 2% ointment has been associated with significant hair regrowth in several studies. Another JAK inhibitor, ruxolitinib, has also been explored for its potential benefits in treating Alopecia Areata. These treatments are part of a broader category of immunosuppressive therapies that target specific pathways involved in the autoimmune response responsible for hair loss.

What other types of research exist?

Promising alternatives to Baricitinib for Alopecia Areata include Tofacitinib and Ruxolitinib, both of which are JAK inhibitors that have shown positive results in clinical studies. Additionally, Dupilumab has shown some benefit in clinical trials and may be considered as a novel alternative, though further studies are needed to confirm its efficacy.

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Janus Kinase (JAK) Inhibitor

Baricitinib for Pediatric Hair Loss (BRAVE-AA-PEDS Trial)

Phase 3

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 36

Awards & highlights

Pivotal Trial

Summary

This trial is testing baricitinib, a medication that may help treat severe hair loss. It targets children aged 6 to less than 18 years who have significant hair loss. The medication works by reducing the immune system's activity that causes hair loss.

Who is the study for?

This trial is for children aged 6 to less than 18 with severe alopecia areata (AA), a hair loss condition. They must have tried at least one treatment without success, had AA for over a year, and experienced an ongoing episode of AA for at least six months. Those with uncontrolled high blood pressure, recent major surgery, hepatitis B or C infections, HIV infection, or other serious health issues cannot participate.

What is being tested?

The study tests the effectiveness and safety of Baricitinib in treating severe alopecia areata in children. It includes a screening period followed by a double-blind treatment phase where participants randomly receive either Baricitinib or placebo without knowing which one they're getting.

What are the potential side effects?

While not specified here, common side effects of Baricitinib may include respiratory infections like colds, nausea, headaches and increased cholesterol levels. Each child's experience can vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Mean Change from Baseline in Family Dermatology Life Quality Index (FDLQI)

Mean Change from Baseline in Hospital Anxiety Depression Scale (HADS)

Mean Change from Baseline in PROMIS Depression Score

+2 more

Side effects data

From 2015 Phase 3 trial • 1307 Patients • NCT01710358

Nasopharyngitis

Upper respiratory tract infection

Bronchitis

Influenza

Back pain

Urinary tract infection

Pharyngitis

100%

80%

60%

40%

20%

Study treatment Arm

BaricitinibTreatment B

Baricitinib Follow-up

Placebo Follow-up

Adalimumab Treatment B

Placebo Treatment B

Adalimumab Follow-up

Baricitinib Treatment A

Adalimumab Treatment A

Placebo Treatment A

Rescue

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Baricitinib Low DoseExperimental Treatment1 Intervention

Participants will receive baricitinib low dose orally.

Group II: Baricitinib High DoseExperimental Treatment1 Intervention

Participants will receive baricitinib high dose orally.

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Baricitinib

2017

Completed Phase 3

~9510

Do I qualify?Apply below to find out

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

The most common treatments for Alopecia Areata, particularly JAK inhibitors like Baricitinib, work by interfering with the JAK-STAT signaling pathway, which is involved in the immune response that attacks hair follicles. By inhibiting this pathway, these drugs reduce inflammation and autoimmunity, promoting hair regrowth. Other treatments, such as cyclosporine and methotrexate, also modulate the immune system but through different mechanisms, such as inhibiting T-cell activation or folate metabolism, respectively. Understanding these mechanisms is crucial for patients as it helps tailor treatments to their specific immune profiles, potentially improving efficacy and reducing side effects.

Case Report: Successful Treatment of Alopecia Universalis With Tofacitinib and Increased Cytokine Levels: Normal Therapeutic Reaction or Danger Signal?