AN INTERVENTIONAL PK, PD, PHASE 1, OPEN-LABEL STUDY TO INVESTIGATE PK AND PD OF MULTIPLE-DOSE RITLECITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA

Pfizer, Inc.0 个研究点开始时间: 2023年9月6日最近更新: 2023年9月11日

适应症

试验速览

暂无简介。

•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

•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

发起方