Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis



Status:Completed
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:5/18/2018
Start Date:April 15, 2016
End Date:April 4, 2017

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

A Phase 2b Randomized, Double‑Blind, Placebo-controlled, Parallel, Multicenter, Dose-ranging, Study To Evaluate The Efficacy And Safety Profile Of Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily
(QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the
efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of
the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease
severity in patients with moderate to severe AD as measured by the Investigator's Global
Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support
further clinical development of PF 04965842.


Inclusion Criteria:

- Male or female subjects between 18 75 years of age, inclusive, at time of informed
consent.

- Must have the following atopic dermatitis criteria:

1. Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic
eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis
(Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.

2. Have inadequate response to treatment with topical medications given for at least
4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg,
because of important side effects or safety risks) within 12 months of the first
dose of study drug.

3. Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the
screening and baseline visits).

Exclusion Criteria:

- History of human immunodeficiency virus (HIV) or positive HIV serology at screening,

- Infected with hepatitis B or hepatitis C viruses.

- Have evidence of active or latent or inadequately treated infection with Mycobacterium
tuberculosis (TB)

- Have received any of the following treatment regiments specified in the timeframes
outlined below:

Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of
first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks
of first dose of study drug: Participation in other studies involving investigational
drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or
attenuated live vaccine.

Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy
(NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning
booth/parlor.

Within 1 week of first dose of study drug: Topical treatments that could affect atopic
dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.
We found this trial at
37
sites
911 Park Avenue
New York, New York 10075
212-710-9855
480
mi
from 43215
New York, NY
Click here to add this to my saved trials
59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
448
mi
from 43215
East Windsor, NJ
Click here to add this to my saved trials
6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
750
mi
from 43215
Tulsa, OK
Click here to add this to my saved trials
Bellaire, Texas 77401
998
mi
from 43215
Bellaire, TX
Click here to add this to my saved trials
Birmingham, Alabama 35209
495
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
Clearwater, Florida 33757
829
mi
from 43215
Clearwater, FL
Click here to add this to my saved trials
1949
mi
from 43215
Encinitas, CA
Click here to add this to my saved trials
263 Farmington Ave
Farmington, Connecticut 06032
548
mi
from 43215
Farmington, CT
Click here to add this to my saved trials
Forest Hills, New York 11375
485
mi
from 43215
Forest Hills, NY
Click here to add this to my saved trials
Hazleton, Pennsylvania 18201
376
mi
from 43215
Hazleton, PA
Click here to add this to my saved trials
Indianapolis, Indiana 46256
158
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46256
166
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32204
670
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
Johnston, Rhode Island 02919
614
mi
from 43215
Johnston, RI
Click here to add this to my saved trials
891
mi
from 43215
Lake Charles, LA
Click here to add this to my saved trials
Las Vegas, Nevada 89119
1756
mi
from 43215
Las Vegas, NV
Click here to add this to my saved trials
Louisville, Kentucky 40202
188
mi
from 43215
Louisville, KY
Click here to add this to my saved trials
Newnan, Georgia 30263
465
mi
from 43215
Newnan, GA
Click here to add this to my saved trials
Norfolk, Virginia 23507
422
mi
from 43215
Norfolk, VA
Click here to add this to my saved trials
681
mi
from 43215
Orange Park, FL
Click here to add this to my saved trials
Orange Park, Florida 32073
681
mi
from 43215
Orange Park, FL
Click here to add this to my saved trials
746
mi
from 43215
Ormond Beach, FL
Click here to add this to my saved trials
Pasadena, California 91105
1965
mi
from 43215
Pasadena, CA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
165
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
Plainfield, Indiana 46168
179
mi
from 43215
Plainfield, IN
Click here to add this to my saved trials
Rapid City, South Dakota 57702
1077
mi
from 43215
Rapid City, SD
Click here to add this to my saved trials
Richmond, Virginia 23233
331
mi
from 43215
Richmond, VA
Click here to add this to my saved trials
Rolling Hills Estates, California 66212
625
mi
from 43215
Rolling Hills Estates, CA
Click here to add this to my saved trials
2041
mi
from 43215
Sacramento, CA
Click here to add this to my saved trials
1419 Village Drive
Saint Joseph, Missouri 64506
624
mi
from 43215
Saint Joseph, MO
Click here to add this to my saved trials
San Antonio, Texas 78218
1130
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
Santa Monica, California 90404
1984
mi
from 43215
Santa Monica, CA
Click here to add this to my saved trials
Tampa, Florida 33624
820
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
Troy, Michigan 48084
179
mi
from 43215
Troy, MI
Click here to add this to my saved trials
Verona, New Jersey 07044
465
mi
from 43215
Verona, NJ
Click here to add this to my saved trials
West Dundee, Illinois 60118
310
mi
from 43215
West Dundee, IL
Click here to add this to my saved trials