A phase 3 multicenter, 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

Phase 3

Completed

Conditions: Atopic dermatitis
atopic eczema
10014982

Registration Number: NL-OMON54631

Lead Sponsor: Pfizer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

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 not be intending to become pregnant, currently pregnant, or
lactating. The following conditions apply:
a. Female subjects of childbearing potential must have a confirmed negative
pregnancy test prior to allocation to treatment.
b. 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 product.
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:
a. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
b. Have medically confirmed ovarian failure; or
c. 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,

Exclusion Criteria

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 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 OR
meets exclusion criteria from qualifying parent studies 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints<br /><br>• The incidence of treatment emergent adverse events.<br /><br>• The incidence of serious adverse events and adverse events leading to<br /><br>discontinuation.<br /><br>• The incidence of clinical abnormalities and change from baseline in clinical<br /><br>laboratory values, ECG measurements, and vital signs.</p><br>

Secondary Outcome Measures