Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
研究单位：[1]Pfizer[2]Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei, China, 430030[3]The second Xiangya Hospital,Central South University Changsha, Hunan, China, 410011[4]The Third Xiangya Hospital of Central South University, Dermatological department Changsha, Hunan, China, 410013[5]The First Affiliated Hospital With Nanjing University Nanjing, Jiangsu, China, 210000[6]Dermatology Hospital of Jiangxi Province Nanchang, Jiangxi, China, 330000[7]Jinan Central Hospital Jinan, Shandong, China, 250013[8]Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin Jinan, Shandong, China, 250022[9]Huashan Hospital Fudan University Shanghai, Shanghai, China, 200040[10]Tianjin Medical University General Hospital, Dermatological Department Tianjin, Tianjin, China, 300052[11]First Affiliated Hospital of Kunming Medical University Kunming, Yunnan, China, 650032[12]The First Affiliated Hospital of Zhejiang University School of Medicine/Dermatology and STD Dept Hangzhou, Zhejiang, China, 310003[13]Hangzhou Third Hospital Hangzhou, Zhejiang, China, 310009[14]The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept Hangzhou, Zhejiang, China, 310009[15]Zhejiang Provincial People's Hospital/Dermatology Department Hangzhou, Zhejiang, China, 310014[16]Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Hangzhou, Zhejiang, China, 310016[17]The Second Affiliated Hospital of Army Medical University,PLA Chongqing, China, 400037[18]Dermatology Department, Shanghai Changzheng Hospital Shanghai, China, 200003[19]Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine/Dermatology Shanghai, China, 200092[20]Shanghai Dermatology Hospital Shanghai, China, 200443[21]Lekarna Pod Kankem Kunta Hora, Czechia, 284 01[22]Kozni ambulance Kutna Hora, s.r.o Kutná Hora, Czechia, 28401
B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying parent study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country.
The B7451015 study also includes a sub-study evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee MRI. The sub-study will be conducted in selected countries at selected sites. Eligible subjects are those who were 12 to <18 years of age at the screening visit of the qualifying parent study and who are currently participating in the main B7451015 study. The sub-study will include serial Magnetic Resonance Imaging (MRI) annually and continue until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued/withdrawn.
