- 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 body weight greater than or equal to 40 kg. Adolescent subjects below the
age of 18 years old 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 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 Phase 3 study OR must
have completed the full rescue treatment period of a qualifying Phase 3 study (if
applicable).
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 not be intending to become pregnant, currently pregnant, or lactating.
The following conditions apply:
1. Female subjects of childbearing potential must have a confirmed negative
pregnancy test prior to randomization.
2. Female subjects of childbearing potential 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.
6. Female subjects of non childbearing potential must meet at least 1 of the
following criteria:
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 study.
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 study.
2. Currently have active forms of other inflammatory skin diseases, ie, not
atopic dermatitis.
3. Have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis,
Lupus) at the time of Day 0 that would interfere with evaluation of atopic
dermatitis or response to treatment.
4. Discontinued from treatment (or rescue treatment period, if applicable)
early in a qualifying Phase 3 study OR triggered discontinuation criteria at
any point during the qualifying Phase 3 study OR meets exclusion criteria of
the qualifying Phase 3 study.
5. Ongoing adverse event in the qualifying Phase 3 study which in the opinion
of the investigator, or sponsor, is an ongoing safety concern OR the subject
is currently triggering safety monitoring criteria in the qualifying Phase 3
study.
6. 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.