A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS

This is a global Phase 2b/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 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

本研究为一项全球IIb/III期临床试验，旨在评估试验性药物PF-06651600在脱发程度≥50%的成人及12岁及以上青少年中的安全性与有效性。本研究采用安慰剂对照设计：部分入组受试者将不会接受活性研究药物，仅服用不含有效成分的片剂（安慰剂）。本研究属于剂量探索研究，将考察5种不同的给药方案。本次研究采用双盲设计，即申办方、研究医师、研究人员与受试者均无法知晓受试者接受的是活性研究药物（或具体给药剂量）还是安慰剂。