A study that allows patients from previous studies to continue on the medication. The aim of the study is to determine how safe and effective PF-04965842 are when taken as the treatment for moderate to severe atopic dermatitis in patients aged 12 years or older. Patients may also receive topical medications if needed.
- Conditions
- Moderate to severe atopic dermatitisMedDRA version: 20.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-004851-22-FR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2300
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 = 40 kg. 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 Phase 3 study OR must have completed the full rescue treatment period of a qualifying Phase 3 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, 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, as detailed in Appendix 2 and Appendix 3.
Are the trial subjects under 18? yes
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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.
3. 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.
4. Discontinued from treatment (or rescue treatment period/open-label run-in 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 from qualifying Phase 3 studies as detailed in Appendix 10 of the protocol.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To estimate the long-term safety of 100 mg and 200 mg once daily (QD) of PF-04965842 with or without topical treatments in adult and adolescent subjects who previously participated in PF-04965842 atopic dermatitis (AD) Phase 3 trials.;Secondary Objective: To estimate the long-term efficacy of PF-04965842.;Primary end point(s): Primary (Safety) Endpoints<br>• The incidence of treatment emergent adverse events.<br>• The incidence of serious adverse events and adverse events leading to discontinuation.<br>• The incidence of clinical abnormalities and change from baseline in clinical laboratory values, electrocardiogram (ECG) measurements, and vital signs.<br>;Timepoint(s) of evaluation of this end point: Through out the study
- Secondary Outcome Measures
Name Time Method