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JAK Inhibitor

PF-06651600 for Alopecia Areata (ALLEGRO-LT Trial)

Phase 3

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

No evidence of terminal scalp hair regrowth within 6 months (de novo only)

De novo participants >=12 to <18 years of age: >=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis

Must not have

Infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to Day 1

Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new drug to treat alopecia areata, which is an autoimmune disease that causes hair loss. The trial is open-label, which means all patients will receive the active drug. There is also a sub-study evaluating the immune response to vaccines in patients who have received the drug for at least 6 months.

Who is the study for?

This trial is for adults and adolescents (12 years and older) with alopecia areata, including severe forms like totalis and universalis. It's open to new participants with significant hair loss due to alopecia that started within the last 10 years, as well as those from prior related studies. People can't join if they have certain ear conditions, a history of some cancers or herpes infections, or recent serious infections.

What is being tested?

The study tests PF-06651600's safety and effectiveness in treating alopecia areata. All participants will receive this drug. A sub-study evaluates immune responses to tetanus and meningococcal vaccines in patients treated with PF-06651600 for at least six months.

What are the potential side effects?

While specific side effects aren't listed here, similar drugs often cause issues like headaches, nausea, increased risk of infection due to immune system changes, and possibly reactions at injection sites.

Eligibility Criteria

Inclusion Criteria

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

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I haven't seen any new hair growth on my scalp in the last 6 months.

Select...

I am between 12 and 18 years old with more than half of my scalp hair lost due to alopecia.

Exclusion Criteria

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

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I haven't been hospitalized or needed IV antibiotics in the last 6 months.

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My hearing has worsened over the last 5 years, or I've had sudden hearing loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Vaccine sub-study: Percentage of subjects with a tetanus booster response

Secondary study objectives

Change from baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) domains

Change from baseline in SALT score

Change from baseline in the anxiety subscale score of the Hospital Anxiety and Depression Scale (HADS)

+10 more

Side effects data

From 2023 Phase 2 trial • 244 Patients • NCT03395184

11%

Crohn's disease

Abdominal pain

SARS-CoV-2 test positive

Upper respiratory tract infection

Diarrhoea

Respiratory tract infection

Muscle spasms

Fatigue

Influenza

Pyrexia

Cough

Ileus

Arthralgia

Ileus paralytic

Abdominal abscess

Female genital tract fistula

Small intestinal obstruction

Tonsillitis

Lymphopenia

Nausea

Vomiting

Bartholin's abscess

Tinnitus

Urinary tract infection

Acne

Headache

100%

80%

60%

40%

20%

Study treatment Arm

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

OLE Period: Placebo QD -> Ritlecitinib 50 mg QD

OLE Period: Placebo QD -> Brepocitinib 30 mg QD

Induction Period: Brepocitinib 60 mg QD

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

Induction Period: Ritlecitinib 200 mg/50 mg QD

Induction Period: Placebo QD

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment sequence 2Experimental Treatment3 Interventions

Participants who previously received study intervention in either study B7931005 or B7981015 will receive 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or 1 of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 6 visit and prior to or on the Month 56 visit of the main B7981032 study.

Group II: Treatment sequence 1Experimental Treatment3 Interventions

Participants who did not previously receive study intervention in either study B7931005 or B7981015 will receive 200 milligrams (mg) PF-06651600, given as four 50 mg tablets once daily (QD) for 1 month, followed by 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or one of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 9 visit and prior to or on the Month 56 visit of the main B7981032 study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PF-06651600

2019

Completed Phase 2

~1900

0 / 4Eligibility criteria met