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A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata

ConditionAlopecia Areata
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorPfizer

About this trial

The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body.

Ritlecitinib is approved in many countries at a dose of 50 mg (milligram) taken by mouth once a day for the treatment of patients 12 years and older with severe alopecia areata. This study will look at both the 50 mg dose and a 100 mg dose.

This study is seeking participants who:

* Are 12 years of age or older (Part 1) * Are 12 to less than 18 years (Part 2) * Have a diagnosis of alopecia areata * Have lost 50% or more of the hair on their scalp * Do not have any other conditions that causes hair loss * Are willing to stop all other treatments that they may be taking for alopecia areata

About 550 participants will take part in Part 1 of this study. About 80 participants will take part in Part 2 of this study.

In Part 1, participants will be chosen by chance, like drawing names out of a hat, to receive 1 of 2 different amounts of ritlecitinib (50 mg and 100 mg) taken by mouth once daily.

The 2 doses of ritlecitinib in this study will be compared to each other and also to data from previous studies. This will help to see if the 100 mg dose of ritlecitinib is safe and effective.

In Part 2, all eligible participants will receive ritlecitinib 100 mg taken by mouth once daily. The data from this part of the study will be combined with the data from Part 1 of the study to help to see if the 100 mg dose of ritlecitinib is safe and effective in adolescent patients with alopecia areata.

People will be in this study for about 13 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as:

* alopecia areata assessment, * physical examinations, * hearing tests, * blood tests, * x-ray, * ECG (electrocardiogram), * photographs of the scalp and eyes (Part 1 only). Participants will also be asked to complete questionnaires about their alopecia areata.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older at screening. Adolescents (12 to <18 years of age at screening) are also eligible for this study, but only if permitted by the local IRB/EC and local regulatory health authority (if applicable). Where these approvals have not been granted, only participants 18 years of age and older at screening will be enrolled. In Part 2 of the study, only adolescents (12 to <18 years of age at both Screening and Day 1) who did not participate in Part 1 will be enrolled.

Have a clinical diagnosis of alopecia areata with no other etiology of hair loss.

≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months.

Current episode of hair loss ≤10 years.

Disqualifiers

Diseases or conditions other than alopecia areata which affect hair loss, including other types of alopecia, other scalp disease that may impact the alopecia areata assessment, or active systemic diseases that may cause hair loss.

History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.

Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria.

Have a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal), or as otherwise judged clinically significant by the investigator, within 3 months prior to Day 1.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ritlecitinib 100 mg

    Drug

    100 mg Capsule

  • Ritlecitinib 50 mg

    Drug

    50 mg Capsule

  • Placebo - 100 mg

    Drug

    Capsule (to match Ritlecitinib 100 mg)

  • Placebo - 50 mg

    Drug

    Capsule (to match Ritlecitinib 50 mg)

Treatment groups

674 Participants
are divided into 5 treatment groups
Group A: Ritlecitinib 50 mgExperimental treatment 2 interventions
Group B: External PlaceboNo intervention 0 interventions
Group C: Ritlecitinib 100 mg (open-label)Experimental treatment 1 intervention
Group D: Ritlecitinib 100 mgExperimental treatment 2 interventions
Group E: Synthetic PlaceboNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Part 1: Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20

Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg once-daily (QD) versus placebo

Time frame
Week 24
2

Part 2: Percentage of participants with TEAEs, SAEs, and AEs leading to discontinuation

Percentage of participants with events, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD

Time frame
Baseline to Follow-up visit (Week 52)
3

Part 2: Percentage of participants with clinically significant laboratory abnormalities

Percentage of participants with clinically significant laboratory abnormalities, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD

Time frame
Baseline to Follow-up visit (Week 52)

Secondary outcomes

1

Part 1: Percentage of participants with absolute SALT score less than or equal to 20

Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 50 mg QD versus placebo

Time frame
Week 24
2

Part 1: EU Only: Percentage of participants with Patient Global Impression of Change (PGI-C) response, defined as a score of "moderately improved" or "greatly improved"

Difference in percentage of participants with PGI-C response between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo

Time frame
Week 24
3

Part 1: US Only: Percentage of participants with absolute SALT score less than or equal to 20

Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg QD versus placebo

Time frame
Week 36
4

Part 1: Change from baseline in SALT score

Difference in the mean absolute change from baseline in SALT score between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD

Time frame
Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
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