Alopecia Areata

Aphase 3, external and synthetic placebo-controlled randomized study with dose - up for non-responders to investigate safety and efficacy of ritlecitinib 50mg and 100mg once daily in adult and adolescent participants years of age and older with alopecia areata.

medical-cross
Alopecia
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All genders
person-wave 18+
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Recruiting now

Overview
Principal Investigator: Jeffrey Sobell, MD

The total duration of this study for each participant is approximately 48weeks, which includes a screening period of 5 weeks, followed by a 48-week treatment period, which includes an External Placebo Control Group at Week 24, a Synthetic Placebo Control Group at Week 36, and an External Ritlecitinib 50 mg Group at Week 48.

Contact Us

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Alysha Zipeto

Study details
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
  • Have a clinical diagnosis of AA 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
Exclusion Criteria
  • Diseases or conditions affecting hair loss, including:
    Other types of alopecia (including, but not limited to, traction and scarring
    alopecia, telogen effluvium). Participants with known 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).
  • Have hearing loss with progression over the previous 5 years, sudden hearing loss, or
    middle or inner ear disease such as otitis media, cholesteatoma, Meniere’s disease,
    labyrinthitis, or other auditory condition that is considered acute, fluctuating or
    progressive.

    At any time prior to the first dose of study intervention: Any JAK inhibitors for use in
    any disease indication.
Study Requirements

The study duration will be approximately 48 weeks with 10 study visits.