A PHASE 3 MULTI-CENTER, LONG-TERM EXTENSION STUDY INVESTIGATING THE EFFICACY AND SAFETY OF ABROCITINIB, WITH OR WITHOUT TOPICAL MEDICATIONS, ADMINISTERED TO SUBJECTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS
A PHASE 3 MULTI-CENTER, LONG-TERM EXTENSION STUDY INVESTIGATING THE EFFICACY AND SAFETY OF ABROCITINIB, WITH OR WITHOUT TOPICAL MEDICATIONS, ADMINISTERED TO SUBJECTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS
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and continue until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued/withdrawn.
Inclusion Criteria:
Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.
Male or female subjects of 12 years of age or older, at the time of informed consent and meets inclusion criterion for minimum body weight (if applicable) from qualifying Parent study. Adolescent subjects below the age of 18 years old (or country-specific age of majority) will only be enrolled in this study if instructed by the sponsor and approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects aged 18 years (or country-specific age of majority) and older will be enrolled.
Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Must have completed the full treatment period of a qualifying Parent study OR must have completed the full rescue treatment period of a qualifying Parent study (if applicable) OR must have completed the full open-label run-in period in B7451014 and did not meet the protocol-specified response criteria at Week 12.
Female subjects who are of childbearing potential (which includes all female subjects aged 12 years and older, regardless of whether they have experienced menarche) must ot be intending to become pregnant, currently pregnant, or lactating. The following onditions apply:
For Czech Republic only, 5 b. is revised and 5 c. is added to require:
Female subjects of childbearing potential 15 years of age who are at risk of pregnancy must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
c. Female subjects less than 15 years of age must not be sexually active, and abstinence per the below definition should be confirmed prior to enrollment. NOTE: Sexual abstinence, defined as completely and persistently refraining from all heterosexual intercourse (including during the entire period of risk associated with the study treatments) may obviate the need for contraception ONLY if this is the preferred and usual lifestyle of the subject.
6. Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
Have undergone a documented hysterectomy and/or bilateral oophorectomy;
Have medically confirmed ovarian failure; or
Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential. 7. Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
8. Must agree to avoid use of prohibited medications throughout the duration of the study. Exclusion Criteria
There are also additional separate inclusion and exclusion criteria to assess eligibility specifically for the B7451015 MRI sub-study.
Birmingham, Alabama 35233, United States
Birmingham, Alabama 35294, United States
Long Beach, California 90808, United States
Los Angeles, California 90033, United States
Mission Viejo, California 92691, United States
Tampa, Florida 33613, United States
Skokie, Illinois 60077, United States
Boston, Massachusetts 02114, United States
Fort Gratiot, Michigan 48059, United States
Winston-Salem, North Carolina 27103, United States
Clackamas, Oregon 97015, United States
Milwaukee, Wisconsin 53226, United States
Milwaukee, Wisconsin 53226, United States
CABA, Buenos Aires C1012AAY, Argentina
Rosario, Santa Fe Province 2000, Argentina
C.a.b.a., C1425DKG, Argentina
C.a.b.a, C1027AAP, Argentina
Saint Leonards NSW, 2065, Australia
Porto Alegre, Rio Grande do Sul 90035-903/90035-003, Brazil
Porto Alegre, Rio Grande do Sul 90160-093, Brazil
Sofia, 1756, Bulgaria
Vancouver, British Columbia V5Z 4E8, Canada
Wuhan, Hubei 430030, China
Changsha, Hunan 410013, China
Jinan, Shandong 250022, China
Tianjin, Tianjin Municipality 300052, China
Hangzhou, Zhejiang 310003, China
Hangzhou, Zhejiang 310009, China
Shanghai, 200092, China
Kunta Hora, 284 01, Czechia
Ostrava - Poruba, 708 52, Czechia
Ostrava - Poruba, 70852, Czechia
Miskolc, 3526, Hungary
Pécs, 7632, Hungary
Rome, 00168, Italy
Yokohama, Kanagawa 220-6208, Japan
Kamimashiki-gun, Kumamoto 861-3106, Japan
Chiyoda-ku, Tokyo 102-0072, Japan
Chuo-ku, Tokyo 104-0031, Japan
Edogawa-ku, Tokyo 133-0052, Japan
Nakano-ku, Tokyo 165-0026, Japan
Shinjyuku-ku, Tokyo 160-0023, Japan
Del. Cuauhtemoc, Mexico City 06720, Mexico
Mérida, Yucatán 97130, Mexico
Chihuahua City, 31238, Mexico
Gdansk, 80-214, Poland
Warsaw, 02-507, Poland
Brasov, JUD. Brasov 500283, Romania
Cluj-Napoca, JUD. CLUJ 400105, Romania
Bratislava - Mestská Cast Nove Mesto, 831 01, Slovakia
Bratislava- Mestská Časť Nové Mesto, 83101, Slovakia
Kosice-Saca, 040 15, Slovakia
Nové Zámky, 940 34, Slovakia
Las Palmas de Gran Canaria, LAS Palmas 35010, Spain
Sheffield, South Yorkshire S5 7AU, United Kingdom