Alopecia Areata
Conditions
Interventions
*Drug: Ritlecitinib 100 mg
-100 mg Capsule
-Other Names:
#PF-06651600
#Litfulo
*Drug: Ritlecitinib 50 mg
-50 mg Capsule
-Other Names:
#PF-06651600
#Litfulo
*Drug: Placebo - 100 mg
-Capsule (to match R
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Age: 1.18 years of age or older at screening. Adolescents (12 to =50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months. 3.Current episode of hair loss <=10 years.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Medical Conditions: 1.Diseases or conditions other than alopecia areata which affect hair loss, including other types of alopecia, other scalp disease that may impact the alopecia areata assessment, or active systemic diseases that may cause hair loss. 2.History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention. 3.Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria. 4.General Infection History: -Have a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal), or as otherwise judged clinically significant by the investigator, within 3 months prior to Day 1. -Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1. NOTE: participants may be rescreened after the infection resolves. -Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis. 5.Specific Viral Infection History: -History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster. -Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility. 6.Other Medical Conditions: -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. -Abnormal findings on the screening chest imaging (eg, chest x-ray) including, but not limited to, presence of active TB or other infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to Screening. -Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. -Have a history of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease. -Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery. 7.Adolescent participants 12 to <18 years of age without one of the following: -Documented evidence from a health professional of having received varicella vaccination (2 doses); or -Evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV IgG Ab result) at Screening. 8.Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Prior/Concomitant Therapy: 9.Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol-defined timelines. Prior/Concurrent Clinical Study Experience: 10.Previous administration with an investigational drug or vaccine within 8 weeks (or longer as determined by the local requirement) or 5 half-lives (wh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20 [Time Frame: Week 24] -Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg once-daily (QD) versus placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| *Percentage of participants with absolute SALT score less than or equal to 20 [Time Frame: Week 24] -Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 50 mg QD versus placebo *Change from baseline in SALT score [Time Frame: Week 24] -Difference in the mean absolute change from baseline in SALT score between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD *EU Only: Percentage of participants with Patient Global Impression of Change (PGI-C) response, defined as a score of "moderately improved" or "greatly improved" [Time Frame: Week 24] -Difference in percentage of participants with PGI-C response between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo *US Only: Percentage of participants with absolute SALT score less than or equal to 20 [Time Frame: Week 36] -Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg QD versus placebo *Percentage of participants with absolute SALT score less than or equal to 20 [Time Frame: Baseline through Week 24] -Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD *Percentage of participants with absolute SALT score less than or equal to 10 [Time Frame: Baseline through Week 24] -Difference in the percentage of participants with SALT score less than or equal to 10 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD *Percentage of participants with absolute SALT score equal to 0 [Time Frame: Baseline through Week 24] -Difference in the percentage of participants with SALT score equal to 0 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD *Change from baseline in SALT score [Time Frame: Baseline through Week 24] -Difference in the mean absolute change from baseline in SALT score between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD *Percentage of participants with EBA (Ey | — |
Countries
Canada, China, Czechia, Japan, Poland, South Korea, Spain, Taiwan, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed