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
Newnan, Georgia 30263
1899
mi
from 91732
Newnan, GA
Click here to add this to my saved trials
59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
2406
mi
from 91732
East Windsor, NJ
Click here to add this to my saved trials
911 Park Avenue
New York, New York 10075
212-710-9855
2434
mi
from 91732
New York, NY
Click here to add this to my saved trials
6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
1254
mi
from 91732
Tulsa, OK
Click here to add this to my saved trials
Bellaire, Texas 77401
1353
mi
from 91732
Bellaire, TX
Click here to add this to my saved trials
Birmingham, Alabama 35209
1785
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Clearwater, Florida 33757
2116
mi
from 91732
Clearwater, FL
Click here to add this to my saved trials
82
mi
from 91732
Encinitas, CA
Click here to add this to my saved trials
263 Farmington Ave
Farmington, Connecticut 06032
2491
mi
from 91732
Farmington, CT
Click here to add this to my saved trials
Forest Hills, New York 11375
2441
mi
from 91732
Forest Hills, NY
Click here to add this to my saved trials
Hazleton, Pennsylvania 18201
2329
mi
from 91732
Hazleton, PA
Click here to add this to my saved trials
Indianapolis, Indiana 46256
1801
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46256
1793
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32204
2128
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
Johnston, Rhode Island 02919
2558
mi
from 91732
Johnston, RI
Click here to add this to my saved trials
1469
mi
from 91732
Lake Charles, LA
Click here to add this to my saved trials
Las Vegas, Nevada 89119
217
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
Louisville, Kentucky 40202
1812
mi
from 91732
Louisville, KY
Click here to add this to my saved trials
Norfolk, Virginia 23507
2336
mi
from 91732
Norfolk, VA
Click here to add this to my saved trials
2130
mi
from 91732
Orange Park, FL
Click here to add this to my saved trials
Orange Park, Florida 32073
2129
mi
from 91732
Orange Park, FL
Click here to add this to my saved trials
2186
mi
from 91732
Ormond Beach, FL
Click here to add this to my saved trials
Pasadena, California 91105
9
mi
from 91732
Pasadena, CA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
2121
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials
Plainfield, Indiana 46168
1780
mi
from 91732
Plainfield, IN
Click here to add this to my saved trials
Rapid City, South Dakota 57702
1043
mi
from 91732
Rapid City, SD
Click here to add this to my saved trials
Richmond, Virginia 23233
2257
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
Rolling Hills Estates, California 66212
1334
mi
from 91732
Rolling Hills Estates, CA
Click here to add this to my saved trials
364
mi
from 91732
Sacramento, CA
Click here to add this to my saved trials
1419 Village Drive
Saint Joseph, Missouri 64506
1337
mi
from 91732
Saint Joseph, MO
Click here to add this to my saved trials
San Antonio, Texas 78218
1193
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
106
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
Santa Monica, California 90404
26
mi
from 91732
Santa Monica, CA
Click here to add this to my saved trials
Tampa, Florida 33624
2129
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Troy, Michigan 48084
1961
mi
from 91732
Troy, MI
Click here to add this to my saved trials
Verona, New Jersey 07044
2419
mi
from 91732
Verona, NJ
Click here to add this to my saved trials
West Dundee, Illinois 60118
1699
mi
from 91732
West Dundee, IL
Click here to add this to my saved trials