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Purpose

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the potential treatment of moderate alopecia areata (AA). This study is seeking participants who are - 12 years or older (if permitted by the local IRB/EC and local regulatory health authority) - have AA with patchy hair loss. The current episode of hair loss has lasted for 6 months or longer but 10 years or less - do not have any other diseases or conditions affecting hair loss. Participants will have a 2 in 3 chance of receiving ritlecitinib 50 mg and a 1 in 3 chance of receiving placebo. The placebo looks like the study medicine but does not contain any active ingredients. Participants will not know what you have been assigned to receive. They will take ritlecitinib or placebo once daily by mouth at home for 24 weeks (6 months). After 24 weeks, the assigned treatment may stay the same or be changed to ritlecitinib 50 mg or 100 mg. This change will depend on how participants' alopecia areata responds to the treatment. Participants will receive the newly assigned treatment for another 23 weeks. About 4 weeks after the last dose, there will be a follow-up visit. At this visit, the team will check on your health. Participants will take part in this study for about 57 weeks. During this time, they will have study visits at the study clinic. Some study checks will be done by phone. We will compare the experiences of people receiving ritlecitinib to those of people who do not. This will help us determine if ritlecitinib is safe and effective.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18 years or older (or the minimum age of consent in accordance with local regulations) 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 - Have a clinical diagnosis of AA with no other etiology of hair loss. - Have >20% to <50% hair loss of the scalp, as measured by SALT. - Current AA episode of hair loss ≥6 months and ≤10 years (Current episode is defined as the continuous period of AA-related scalp hair loss since the last time the subject had no visible scalp patches).

Exclusion Criteria

  1. Diseases or conditions affecting hair loss, including: - Other types of alopecia (including, but not limited to, traction and scarring alopecia, telogen effluvium). Participants with androgenetic alopecia will be excluded. - Other scalp disease that may impact AA assessment (eg, scalp psoriasis, dermatitis, etc.). - Active systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ritlecitinib 50 milligrams (mg) 		Participants will receive 1 ritlecitinib 50 mg capsule QD orally from Day 1 to Week 24. At Week 24: Responders will be allocated to the below: Arm 1A (Ritlecitinib 50 mg R Group): 1 ritlecitinib 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48. Non-Responders will be re-randomized to either of the below: Arm 1B (Ritlecitinib 50 mg NR→50 mg Group): 1 ritlecitinib 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48. Arm 1C (Ritlecitinib 50 mg NR→100 mg Group): 1 ritlecitinib 100 mg capsule QD and 1 placebo 50 mg capsule QD orally through Week 48.
  • Drug: Ritlecitinib 100 mg
    100 mg capsule taken orally once daily
  • Drug: Ritlecitinib 50 mg
    50 mg capsule taken orally once daily
Placebo Comparator
Placebo 		Participants will receive 1 placebo 50 mg capsule QD orally from Day 1 to Week 24 At Week 24: Responders will be allocated to the below: Arm 2A (Placebo R Group): 1 placebo 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48. Non-Responders will be allocated to the below: Arm 2B (Placebo NR→Ritlecitinib 50 mg Group): 1 ritlecitinib 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48.
  • Drug: Ritlecitinib 100 mg
    100 mg capsule taken orally once daily
  • Drug: Ritlecitinib 50 mg
    50 mg capsule taken orally once daily
  • Other: Placebo
    Capsule matching either 50mg or 100 mg ritlecitinib capsule taken orally once daily

Recruiting Locations

Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250

Revival Research Institute, LLC
Troy, Michigan 48084

Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania 19462

Texas Dermatology and Laser Specialists
San Antonio, Texas 78218

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.