Alopecia Areata
Conditions
Interventions
Product Name: Ritlecitinib
Product Code: PF-06651600
Pharmaceutical Form: Capsule
INN or Proposed INN: Ritlecitinib tosylate
Current Sponsor code: PF-06651600
Other descriptive name: Janus kinase (JAK
Sponsors
Pfizer, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants who are 6 to less than12 years old at the baseline visit. 2. A diagnosis of severe AA, including AT and AU, with =50% scalp hair loss due to AA (ie, a SALT score of =50) at both the Screening and Baseline visits, without evidence of terminal hair regrowth within the previous 12 months. Are the trial subjects under 18? yes Number of subjects for this age range: 15 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. A known congenital cause of AA, other systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc) or other etiology of hair loss (eg, telogen effluvium, androgenetic alopecia, etc). 2. Any present malignancies or history of malignancies, history of any lymphoproliferative disorder 3. History (one or more episodes) of CMV, varicella, herpes zoster (shingles) or disseminated herpes simplex. 4. Other medical or psychiatric condition (including recent [within the past year] or active suicidal ideation/behavior) that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study. 5. Not up to date with all age appropriate vaccines (including 2-dose vaccination for varicella) or vaccination with attenuated live vaccine within 6 weeks of first dose of study medicine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the Pharmacokinetics (PK) of ritlecitinib in children with AA 6 to <12 years of age;Secondary Objective: To further characterize the PK of ritlecitinib in children with AA 6 to <12 years of age To characterize the pharmacodynamics (PD) of ritlecitinib in children with AA 6 to <12 years of age. To evaluate the safety and tolerability of ritlecitinib in children with AA 6 to <12 years of age. To assess the overall palatability, acceptability, and tolerability of the proposed age appropriate formulation in children with AA aged 6 to <12 years of age. ;Primary end point(s): AUC24 on Day 7 ;Timepoint(s) of evaluation of this end point: Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cmax, Tmax, CL/F, VZ/F and t½ on Day 7 Change from baseline in interferon gamma IP-10 and lymphocyte subsets (T cell, B cell, and NK cells) on Day 7 TEAE Treatment related AEs through Day 35 Serious AEs (SAEs) and AEs leading to discontinuation through Day 35 Clinically significant abnormalities in vital signs through Day 7 Clinically significant abnormalities in clinical laboratory Values through day 7 Taste assessment Day 1 and Day 7;Timepoint(s) of evaluation of this end point: Day 7 Through Day 35 Through Day 7 Day 1 and Day 7 | — |
Countries
United States
Contacts
Public ContactClinicaTrials.gov Call Center
Pfizer, Inc.
Outcome results
None listed