alopecia areata (AA)
Conditions
Interventions
investigational material(s)
Generic name etc : ritlecitinib tosylate
INN of investigational material : ritlecitinib tosylate
Therapeutic category code : 399
Dosage and Administration for Investigation
Sponsors
Pfizer R&D Japan G.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria- For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study: Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed. De novo participants >=12 to =50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis De novo participants >=18 years of age and participants from Study B7931005 or B7981015 with >30 days between first visit in B7981032 and last dose in the prior study: >=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis No evidence of terminal scalp hair regrowth within 6 months (de novo only) Current episode of terminal scalp hair loss <=10 years (de novo only)
Exclusion criteria
Exclusion criteria: Exclusion Criteria- For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study: Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive History of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ History of a single episode of disseminated herpes zoster or disseminated herpes simplex, or a history of more than one episode of localized, dermatomal herpes zoster Infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to Day 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Number of subjects reporting treatment-emergent adverse events, Number of subjects reporting serious adverse events, Number of subjects reporting adverse events leading to discontinuation, Number of subjects with clinically significant abnormalities in vital signs, Number of subjects with clinically significant abnormalities in clinical laboratory values [Time Frame: Baseline through Month 36] Vaccine sub-study: Percentage of subjects with a tetanus booster response [Time Frame: Vaccine sub-study Month 1] | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=10, Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=20, Change from baseline in SALT score, Percentage of subjects with a 75% improvement in SALT score from baseline, [Time Frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36] Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score, Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score, Patient's Global Impression of Change (PGI-C) response, defined as PGI-C score of "moderately improved" or "greatly improved", Change from baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) domains, Change from baseline in the depression subscale score of the Hospital Anxiety and Depression Scale (HADS), Change from baseline in the anxiety subscale score of the Hospital Anxiety and Depression Scale (HADS), Improvement on the Hospital Anxiety and Depression Scale (HADS) among participants with a baseline subscale score indicative of depression who achieved a "normal" subscale score indicative of an absence of depression, Improvement on the Hospital Anxiety and Depression Scale (HADS) among participants with a baseline subscale score indicative of anxiety who achieved a "normal" subscale score indicative of an absence of anxiety, [Time Frame: Months 1, 3, 6, 9, 12, 18, 24, and 36] | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed