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円形脱毛症治療におけるPF-06651600の長期投与

基本情報

NCT ID
NCT04006457
ステータス
実施中(募集終了)
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
1,052
治験依頼者名
Pfizer

概要

This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug. A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.

対象疾患

Alopecia Areata

介入

PF-06651600(DRUG)
Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine(BIOLOGICAL)
Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine(BIOLOGICAL)

依頼者(Sponsor)

実施施設 (7)

順天堂大学医学部附属 順天堂東京江東高齢者医療センター

Koto-ku, Tokyo, Japan

東北大学病院

Sendai, Miyagi, Japan

東京医科大学病院

Tokyo, Japan

大阪公立大学医学部附属病院

Osaka, Japan

浜松医科大学医学部附属病院

Hamamatsu, Shizuoka, Japan

杏林大学医学部付属病院

Mitaka-shi, Tokyo, Japan

名古屋市立大学病院

Nagoya, Aichi-ken, Japan