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Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

Last updated on November 9, 2018

FOR MORE INFORMATION
Study Location
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT03422822
Pfizer
Recruiting
Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

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Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
A Phase 3 Randomized, Double Blind, Multi Center, Long Term Extension Study Investigating The Efficacy And Safety Of Pf 04965842, 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 PF-04965842 with or without Topical Medications in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis and have completed a qualifying Phase 3 study. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated over approximately two years of study participation. Patients who meet safety step-down criteria will have their dose reduced once, from 200 mg QD to 100 mg QD, or from 100 mg QD to placebo.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dermatitis, Atopic
  • Drug: PF-04965842 100 mg
    PF-04965842 100 mg, administered as two tablets to be taken orally once daily for up to 92 weeks.
  • Drug: PF-04965842 200 mg
    PF-04965842 200 mg, administered as two tablets to be taken orally once daily for up to 92 weeks
  • Drug: Placebo
    For subjects whose dose was changed from 100 mg PF-04965842 to placebo, one tablet will be administered to be taken orally once daily for the remainder of the study.
  • Drug: PF-04965842 100 mg
    For subjects whose dose was changed from 200 mg PF-04965842 to 100 mg PF-04965842, one tablet will be administered to be taken orally once daily for the remainder of the study.
  • Experimental: PF-04965842 100 mg
    Interventions:
    • Drug: PF-04965842 100 mg
    • Drug: Placebo
  • Experimental: PF-04965842 200 mg
    Interventions:
    • Drug: PF-04965842 200 mg
    • Drug: PF-04965842 100 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1435
July 4, 2021
July 4, 2021   (Final data collection date for primary outcome measure)

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 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.

      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 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.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03422822
B7451015
2017?004851?22 ( EudraCT Number )
JADE EXTEND B745105 ( Other Identifier: Alias Study Number )
JADE EXTEND ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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