Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib

Launched by PFIZER · Jul 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called ritlecitinib for treating alopecia areata (AA), a condition that causes hair loss on the scalp and other areas of the body. Alopecia areata can affect people of all ages, and the trial aims to gather more information about how well ritlecitinib works in real-life situations, beyond the results seen in earlier studies. Ritlecitinib is approved for adults and adolescents aged 12 and older, and this study will help doctors understand patient experiences and outcomes when this medication is used.

To participate in the trial, individuals need to be at least 12 years old and have been diagnosed with alopecia areata by a certified dermatologist. They should be willing to attend regular clinic visits and complete questionnaires about their health. However, those with other forms of hair loss or certain scalp diseases won't be eligible. Participants can expect to receive ritlecitinib as prescribed by their doctor and will contribute to important research that could help improve treatment for alopecia areata in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female patients aged \>12 years at baseline.
• • 2. Patients with diagnosis of alopecia areata confirmed by a certified dermatologist, who are prescribed ritlecitinib as per the product label independently of the decision to enroll a patient in this study.
• • 3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Following receipt of oral and written information about the trial, the adolescent (depending on local institutional review board/independent ethics committee requirements) must provide assent, and one or both (according to local regulations) parents or guardians of the child must provide signed informed consent before any study-related activity is carried out.
• • 4. Patients, who in the opinion of the investigator, are willing and able to comply with regular clinic visits as per standard practice at the site and agree to complete PRO questionnaires and other patient completed questions.
• Exclusion Criteria:
• • 1. Diagnosed with other types of alopecia or other diseases that can cause hair loss (including, but not limited to known androgenetic alopecia, traction and scarring alopecia, telogen effluvium).
• • 2. Diagnosed with other scalp diseases that may impact AA assessment (e.g., scalp psoriasis, dermatitis, etc.) or other active systemic diseases that may cause hair loss (e.g., lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc.). that could interfere with assessment of hair loss/regrowth.
• • 3. Patients previously treated with ritlecitinib or other JAK inhibitors.
• • 4. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.