1. 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.
2. 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.
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and
other study procedures.
4. 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.
5. 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
1. Female subjects of childbearing potential must have a confirmed negative
pregnancy test prior to allocation to treatment.
2. Female subjects of childbearing potential must agree to use a highly effective
method of contraception (as per Section 4.4.1) for the duration of the active
treatment period and for at least 28 days after the last dose of investigational
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.
3. 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
1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
2. Have medically confirmed ovarian failure; or
3. 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
1. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
2. Currently have active forms of other inflammatory skin diseases, ie, not AD or have
evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of
Day -1 that would interfere with evaluation of atopic dermatitis or response to treatment.
3. Discontinued from treatment (or rescue treatment period/open-label run-in period, if
applicable) early in a qualifying Parent study OR triggered a discontinuation criterion at
any point during the qualifying Parent study which in the opinion of the investigator, or
sponsor, is an ongoing safety concern.
4. Ongoing adverse event in the qualifying Parent study which in the opinion of the
investigator, or sponsor, is an ongoing safety concern. 5. Investigator site staff members
directly involved in the conduct of the study and their family members, site staff members
otherwise supervised by the investigator, or subjects who are Pfizer employees, including
their family members, directly involved in the conduct of the study.