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

Conditions

• Alopecia Areata

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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)

Study Details

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.

Key Dates

First listed

Mar 13, 2025

Start date

Apr 1, 2025

Status verified

Aug 2026

Primary completion

Mar 19, 2028

Completion

Mar 19, 2028

Study Design

Enrollment

1,330 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ritlecitinib 50 mg
  Participants in Part 1 will be randomized to Ritlecitinib 50 mg QD for 24 weeks. Depending on response status at Week 24 (ie, whether the participant has a SALT score of less than or equal to 20), the participant may be re-randomized to Ritlecitinib 50 mg QD or Ritlecitinib 100 mg QD for another 24 weeks. Data from participants who are non-responders (ie, had a SALT score greater than 20) at Week 24 and re-randomized to Ritlecitinib 50 mg will be augmented with data from an External Ritlecitinib 50 mg QD Group for comparisons at Week 48. The External Ritlecitinib 50 mg QD Group will be constructed using patient-level data from the appropriately chosen Pfizer clinical study in participants who received Ritlecitinib 50 mg QD and were non-responders at Week 24 and continued receiving ritlecitinib 50 mg QD up to Week 48. In addition to the active Ritlecitinib 50 mg capsule, a placebo capsule matching the Ritlecitinib 100 mg capsule will be given in order to maintain the blind.
• No Intervention: External Placebo
  This group will be constructed using participant-level data at Week 24 from placebo groups of the appropriately chosen Pfizer clinical studies of Ritlecitinib in participants with alopecia areata. This data will be used for comparison between each Ritlecitinib dose and placebo at Week 24. As this arm will utilize data from other studies, no participants will be randomized to receive only placebo in this study.
• Experimental: Ritlecitinib 100 mg
  Participants in Part 1 will be randomized to Ritlecitinib 100 mg QD for 48 weeks. In addition to the active Ritlecitinib 100 mg capsule, a placebo capsule matching the Ritlecitinib 50 mg capsule will be given in order to maintain the blind.
• No Intervention: Synthetic Placebo
  This group will be constructed using participant-level data up to Week 36 from the placebo groups of the appropriately chosen Pfizer clinical studies of Ritlecitinib in participants with alopecia areata and a longitudinal model and extrapolation. This data will be used for comparison between Ritlecitinib 100 mg and placebo at Week 36. As this arm will utilize data from other studies, no participants will be randomized to receive only placebo in this study.
• Experimental: Ritlecitinib 100 mg (open-label)
  Participants in Part 2 will be assigned to receive one open-label Ritlecitinib 100 mg capsule once daily by mouth for 48 weeks.

Primary Outcome Measure

Part 1: Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20 [ Time Frame: Week 24 ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (60)

Find similar trials in Birmingham, AL

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