What side effects are associated with this type of intervention?

Common treatments for Alopecia Areata include JAK inhibitors like tofacitinib and baricitinib, as well as other immunosuppressants such as methotrexate, azathioprine, and cyclosporine. JAK inhibitors can cause side effects such as nasopharyngitis, headache, and elevated liver enzymes. Methotrexate may lead to liver toxicity, bone marrow suppression, and gastrointestinal issues. Azathioprine can cause gastrointestinal disturbances, liver enzyme elevation, and bone marrow suppression. Cyclosporine is associated with serious adverse effects like nephrotoxicity, hypertension, and increased risk of infections, which limit its long-term use.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Alopecia Areata that are Janus Kinase (JAK) inhibitors like Ritlecitinib. However, other JAK inhibitors such as tofacitinib and baricitinib have been studied for their potential in treating Alopecia Areata. These drugs have shown promise in clinical trials but have not yet received FDA approval specifically for Alopecia Areata.

What other types of research exist?

Promising alternatives to Ritlecitinib for Alopecia Areata include Tofacitinib and Dupilumab. Tofacitinib, a JAK inhibitor, has shown hair regrowth in both adults and children in clinical studies. Dupilumab, an IL-4 receptor alpha antagonist, has demonstrated potential benefits in a phase 2 trial, although further studies are needed to confirm its efficacy.

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Janus Kinase (JAK) Inhibitor

Ritlecitinib for Alopecia Areata (Allegro2a Trial)

Phase 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

Diagnosis of alopecia areata, including alopecia totalis and alopecia universalis

Diagnosis of alopecia areata, including alopecia totalis and alopecia universalis.

Must not have

Active or chronic infection; or infection requiring hospitalization or IV antimicrobials within 6 months

Concomitant medications associated with peripheral neurologic or hearing loss

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 3e, 6e, 9e, 12e and 15e (month 3, 6, 9, 12 and 15 in the active therapy extension phase). baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.

Summary

This trial is testing a medication called ritlecitinib to see if it is safe for adults aged 18 to 50 who have lost a lot of hair due to Alopecia Areata. The medication works by stopping the immune system from attacking hair follicles, which may help hair grow back. Ritlecitinib is being investigated as a treatment for alopecia areata, offering a rapid onset and potentially superior safety profile over other treatments.

Who is the study for?

Adults aged 18 to ≤50 with Alopecia Areata, including alopecia totalis and universalis, who have lost at least 25% of scalp hair. Participants must have stable health conditions, normal neurological exams (except for certain neuropathies), normal hearing, and no significant medical issues or recent serious infections.

What is being tested?

The trial is testing the safety of a drug called ritlecitinib (PF-06651600) compared to a placebo in treating hair loss from Alopecia Areata. It's a global Phase 2a study where participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting.

What are the potential side effects?

Potential side effects may include reactions specific to ritlecitinib but are not detailed here. Common side effects could range from mild skin irritation at the application site to more systemic responses depending on how the body reacts to new medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a form of severe hair loss.

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I have been diagnosed with a form of severe hair loss.

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My hearing and brainstem auditory tests are normal.

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I have lost at least 25% of my hair due to alopecia areata.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had a serious infection or needed IV antibiotics in the last 6 months.

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I am not taking any medications that could cause nerve damage or hearing loss.

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I have active or untreated hepatitis.

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I or a close family member have had issues with nerve damage.

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I have had shingles more than once or it has spread in my body.

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I have active or untreated latent TB.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 3e, 6e, 9e, 12e and 15e (month 3, 6, 9, 12 and 15 in the active therapy extension phase). baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 3e, 6e, 9e, 12e and 15e (month 3, 6, 9, 12 and 15 in the active therapy extension phase). baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3e, 6e, 9e, 12e and 15e (month 3, 6, 9, 12 and 15 in the active therapy extension phase). baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change From Baseline in I-V Interwave Latency on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9

Change From Baseline in I-V Interwave Latency on Brainstem Auditory Evoked Potentials (BAEP) at a Stimulus Intensity of 80 Decibels (dB) From the Right Side at Month 9

Secondary study objectives

Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E

Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9

Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 6 and Month 9

+25 more

Side effects data

From 2023 Phase 2 trial • 244 Patients • NCT03395184

11%

Crohn's disease

Abdominal pain

SARS-CoV-2 test positive

Diarrhoea

Respiratory tract infection

Upper respiratory tract infection

Muscle spasms

Fatigue

Pyrexia

Influenza

Abdominal abscess

Female genital tract fistula

Cough

Lymphopenia

Ileus

Ileus paralytic

Nausea

Small intestinal obstruction

Vomiting

Bartholin's abscess

Tonsillitis

Tinnitus

Urinary tract infection

Arthralgia

Headache

Acne

100%

80%

60%

40%

20%

Study treatment Arm

OLE Period: Placebo QD -> Ritlecitinib 50 mg QD

OLE Period: Ritlecitinib 200 mg/50 mg QD -> Ritlecitinib 50 mg QD

OLE Period: Placebo QD -> Brepocitinib 30 mg QD

Induction Period: Placebo QD

Induction Period: Ritlecitinib 200 mg/50 mg QD

Induction Period: Brepocitinib 60 mg QD

OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment Arm: PF-06651600Experimental Treatment1 Intervention

ritlecitinib 200 milligram (mg) once per day (QD) (four 50 mg tablets) for 4 weeks then ritlecitinib 50 mg tablet QD through month 24. At Month 9, participants assigned to this treatment arm will also receive 3 tablets of placebo for 4 weeks to maintain the blind with the other arm. After month 24, participants switch to 50 mg capsules, 1 QD, up to month 60.

Group II: Control Arm (Placebo) followed by active therapy extensionExperimental Treatment1 Intervention

matching comparator: placebo QD (4 tablets x 4 weeks then 1 tablet x 8 months) then ritlecitinib 200 mg QD (four 50 mg tablets) for 4 weeks then ritlecitinib 50 mg tablet QD through month 24. After month 24, participants switch to 50 mg capsules, 1 QD, up to month 60.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PF-06651600

2019

Completed Phase 2

~1900

Placebo

1995

Completed Phase 3

~2670

0 / 10Eligibility 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

Janus Kinase (JAK) inhibitors, such as Ritlecitinib, work by interfering with the JAK-STAT signaling pathways, which are involved in the immune response that leads to hair follicle destruction in Alopecia Areata. By inhibiting these pathways, JAK inhibitors can reduce inflammation and autoimmunity, promoting hair regrowth. Other common treatments include topical immunotherapy (e.g., DPCP, SADBE), which induces a mild allergic reaction to distract the immune system from attacking hair follicles, and corticosteroids, which reduce inflammation and suppress the immune response. Understanding these mechanisms is crucial for patients, as it helps them grasp how these treatments can potentially restore hair growth and manage their condition.

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