Purpose

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.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.
  • 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.
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
  • 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).
  • 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:
  • Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization.
  • 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.
  • Female subjects of non childbearing potential must meet at least 1 of the following criteria:
  • Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  • Have medically confirmed ovarian failure; or
  • 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PF-04965842 100 mg
  • 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: 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.
Experimental
PF-04965842 200 mg
  • 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: 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.

Recruiting Locations

The University of Texas Health Science Center Houston
Houston, Texas 77030

More Details

NCT ID
NCT03422822
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.