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



Status:Recruiting
Conditions:Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - Any
Updated:3/17/2019
Start Date:March 8, 2018
End Date:December 5, 2021
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

Use our guide to learn which trials are right for you!

A PHASE 3 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.


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.
We found this trial at
96
sites
?
mi
from
Skokie, IL
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials
911 Park Avenue
New York, New York 10075
212-710-9855
?
mi
from
New York, NY
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Anaheim, California 92804
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Arlington, Texas 76011
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baton Rouge, Louisiana 70808
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Bellaire, Texas 77401
?
mi
from
Bellaire, TX
Click here to add this to my saved trials
3555 Olentangy River Road
Bexley, Ohio 43214
?
mi
from
Bexley, OH
Click here to add this to my saved trials
Birmingham, Alabama 35209
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama 35205
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boca Raton, Florida 33486
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
C.a.b.a.,
Click here to add this to my saved trials
Cape Coral, Florida 33991
?
mi
from
Cape Coral, FL
Click here to add this to my saved trials
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Clarkston, Michigan 48346
?
mi
from
Clarkston, MI
Click here to add this to my saved trials
Clearwater, Florida 33757
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
170 South Parkside Drive
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Coral Gables, Florida 33146
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Doral, Florida 33166
?
mi
from
Doral, FL
Click here to add this to my saved trials
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
Forest Hills, New York 11375
?
mi
from
Forest Hills, NY
Click here to add this to my saved trials
Fort Worth, Texas 76244
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
17271 Brookhurst Street
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Fremont, California 94538
?
mi
from
Fremont, CA
Click here to add this to my saved trials
Houston, Texas 77082
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Hurst, Texas 76054
?
mi
from
Hurst, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46256
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Laguna Hills, California 92653
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
5901 Steilacoom Boulevard Southwest
Lakewood, Washington 98499
?
mi
from
Lakewood, WA
Click here to add this to my saved trials
2919 West Swann Avenue
Largo, Florida 33770
?
mi
from
Largo, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89119
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Los Alamitos, CA
Click here to add this to my saved trials
2115 Stanley Gault Parkway
Louisville, Kentucky 40217
?
mi
from
Louisville, KY
Click here to add this to my saved trials
485 East Gray Street
Louisville, Kentucky 40217
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Louisville, Kentucky 40216
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Macon, GA
Click here to add this to my saved trials
Memphis, Tennessee 38119
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Memphis, Tennessee 38117
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33184
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Mission Viejo, CA
Click here to add this to my saved trials
16111 North Brinson Street
Nampa, Idaho 83687
?
mi
from
Nampa, ID
Click here to add this to my saved trials
3810 Springhurst Boulevard
New Albany, Indiana 47150
?
mi
from
New Albany, IN
Click here to add this to my saved trials
New York, New York 10022
?
mi
from
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia 23507
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
2010 Jacobssen Drive
Normal, Illinois 61761
?
mi
from
Normal, IL
Click here to add this to my saved trials
Oceanside, California 92056
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
4200 West Memorial Road
Oklahoma City, Oklahoma 73120
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orange Park, Florida 32073
?
mi
from
Orange Park, FL
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Orlando, Florida 32801
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Overland Park, Kansas 66215
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
Owensboro, Kentucky 42303
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
Owensboro, Kentucky 43201
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19103
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Plainfield, Indiana 46168
?
mi
from
Plainfield, IN
Click here to add this to my saved trials
Portland, Oregon 97223
?
mi
from
Portland, OR
Click here to add this to my saved trials
3100 Duraleigh Road
Raleigh, North Carolina 27612
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rapid City, South Dakota 57702
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
Rolling Hills Estates, California 66212
?
mi
from
Rolling Hills Estates, CA
Click here to add this to my saved trials
1419 Village Drive
Saint Joseph, Missouri 64506
?
mi
from
Saint Joseph, MO
Click here to add this to my saved trials
San Antonio, Texas 78218
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
15 Santa Rosa Street
San Luis Obispo, California 93405
?
mi
from
San Luis Obispo, CA
Click here to add this to my saved trials
Santa Ana, California 92701
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
1821 Wilshire Boulevard
Santa Monica, California 90403
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Savannah, Georgia 31406
?
mi
from
Savannah, GA
Click here to add this to my saved trials
Seattle, Washington 98101
?
mi
from
Seattle, WA
Click here to add this to my saved trials
510 South Cowley Street
Spokane, Washington 99202
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tacoma, Washington 98405
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
1901 South Union Avenue
Tacoma, Washington 98405
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tampa, Florida 33624
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Troy, Michigan 48084
?
mi
from
Troy, MI
Click here to add this to my saved trials
1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
8108 Market Street
Wilmington, North Carolina 28411
?
mi
from
Wilmington, NC
Click here to add this to my saved trials