Open-label Study of Dupilumab (REGN668/SAR231893) in Patients With Atopic Dermatitis



Status:Enrolling by invitation
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:2/9/2017
Start Date:October 2013
End Date:December 2018

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

An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials

This is an open label extension study for patients who participated in placebo-controlled
dupilumab atopic dermatitis (AD) trials. The study primarily evaluates long term safety
(adverse events) and immunogenicity. Efficacy parameters are based on Investigator Global
Assessment (IGA), Eczema Area and Severity Index (EASI) and the Pruritus Numerical Rating
Scale (NRS).


The inclusion criteria include, but are not limited to, the following:

1. Participation in a prior clinical trial of dupilumab for AD and met one of the
following:

1. Received study treatment and adequately completed the assessments required for
both the treatment and follow-up periods of the parent studies (except studies
listed in b) as defined in the parent protocols

2. Received study treatment in one the studies that have completed last patient
last visit : R668-AD-0914, R668-AD-1026, R668-AD-1117, R668-AD-1021,
R668-AD-1121, and R668-AD-1307 irrespective of duration of participation.

3. Underwent screening in R668-AD-1334 (Liberty AD SOLO 1) or R668-AD-1416 (Liberty
AD SOLO 2), but could not be randomized due to randomization closure.

2. Willing and able to comply with all clinic visits and study-related procedures

3. Able to understand and complete study-related questionnaires

4. Provide signed informed consent

Exclusion Criteria:

The exclusion criteria include, but are not limited to, the following:

1. Patients who, during their participation in a previous dupilumab clinical trial,
developed a serious adverse event (SAE) deemed related to dupilumab*, which in the
opinion of the investigator or of the medical monitor could indicate that continued
treatment with dupilumab may present an unreasonable risk for the patient.

2. Patients who, during their participation in a previous dupilumab clinical trial,
developed an AE that was deemed related to dupilumab* and led to study treatment
discontinuation, which in the opinion of the investigator or of the medical monitor
could indicate that continued treatment with dupilumab may present an unreasonable
risk for the patient.

3. Conditions in the previous dupilumab study consistent with protocol-defined criteria
for permanent study drug discontinuation, if deemed related to dupilumab* or led to
investigator - or sponsor-initiated withdrawal of patient from the study (eg,
non-compliance, inability to complete study assessments, etc.).

*Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded,
conditions deemed related to the study treatment will be considered related to
dupilumab.

4. Treatment with an investigational drug, other than dupilumab, within 8 weeks or
within 5 half-lives (if known), whichever is longer, before the baseline visit

5. Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during
the patient's participation in this study
We found this trial at
103
sites
2267
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
649
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
1920
mi
from 91732
Alpharetta, GA
Click here to add this to my saved trials
1204
mi
from 91732
Arlington, TX
Click here to add this to my saved trials
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
1213
mi
from 91732
Austin, TX
Click here to add this to my saved trials
106
mi
from 91732
Bakersfield, CA
Click here to add this to my saved trials
1935
mi
from 91732
Bay City, MI
Click here to add this to my saved trials
1353
mi
from 91732
Bellaire, TX
Click here to add this to my saved trials
2388
mi
from 91732
Berlin, NJ
Click here to add this to my saved trials
2361
mi
from 91732
Bethlehem, PA
Click here to add this to my saved trials
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
2312
mi
from 91732
Boca Raton, FL
Click here to add this to my saved trials
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
2180
mi
from 91732
Buffalo, NY
Click here to add this to my saved trials
818
mi
from 91732
Centennial, CO
Click here to add this to my saved trials
2194
mi
from 91732
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29412
2184
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
1853
mi
from 91732
Chattanooga, TN
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1880
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
2117
mi
from 91732
Clearwater, FL
Click here to add this to my saved trials
2032
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
212
mi
from 91732
Clovis, CA
Click here to add this to my saved trials
1902
mi
from 91732
Columbus, GA
Click here to add this to my saved trials
2272
mi
from 91732
Corning, NY
Click here to add this to my saved trials
28
mi
from 91732
Costa Mesa, CA
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
817
mi
from 91732
Denver, CO
Click here to add this to my saved trials
2406
mi
from 91732
East Windsor, NJ
Click here to add this to my saved trials
1511
mi
from 91732
Edina, MN
Click here to add this to my saved trials
82
mi
from 91732
Encinitas, CA
Click here to add this to my saved trials
1715
mi
from 91732
Evansville, IN
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
1951
mi
from 91732
Farmington Hills, MI
Click here to add this to my saved trials
2440
mi
from 91732
Forest Hills, NY
Click here to add this to my saved trials
2315
mi
from 91732
Fort Lauderdale, FL
Click here to add this to my saved trials
1339
mi
from 91732
Fort Smith, AR
Click here to add this to my saved trials
327
mi
from 91732
Fremont, CA
Click here to add this to my saved trials
1512
mi
from 91732
Fridley, MN
Click here to add this to my saved trials
2029
mi
from 91732
Greer, SC
Click here to add this to my saved trials
218
mi
from 91732
Henderson, NV
Click here to add this to my saved trials
2141
mi
from 91732
High Point, NC
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
1793
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
21
mi
from 91732
Inglewood, CA
Click here to add this to my saved trials
2127
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
2377
mi
from 91732
Jenkintown, PA
Click here to add this to my saved trials
2308
mi
from 91732
Lake Worth, FL
Click here to add this to my saved trials
208
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
25
mi
from 91732
Lomita, CA
Click here to add this to my saved trials
21
mi
from 91732
Long Beach, CA
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
1978
mi
from 91732
Macon, GA
Click here to add this to my saved trials
627
mi
from 91732
Medford, OR
Click here to add this to my saved trials
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
?
mi
from 91732
Miami Lakes, FL
Click here to add this to my saved trials
1511
mi
from 91732
Minneapolis, MN
Click here to add this to my saved trials
1763
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
1655
mi
from 91732
New Orleans, LA
Click here to add this to my saved trials
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
1900
mi
from 91732
Newnan, GA
Click here to add this to my saved trials
2326
mi
from 91732
Newport News, VA
Click here to add this to my saved trials
2336
mi
from 91732
Norfolk, VA
Click here to add this to my saved trials
1648
mi
from 91732
Normal, IL
Click here to add this to my saved trials
1169
mi
from 91732
Norman, OK
Click here to add this to my saved trials
73
mi
from 91732
Oceanside, CA
Click here to add this to my saved trials
21
mi
from 91732
Orange, CA
Click here to add this to my saved trials
2182
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
2183
mi
from 91732
Ormond Beach, FL
Click here to add this to my saved trials
1335
mi
from 91732
Overland Park, KS
Click here to add this to my saved trials
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
2119
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials
1780
mi
from 91732
Plainfield, IN
Click here to add this to my saved trials
1501
mi
from 91732
Plymouth, MN
Click here to add this to my saved trials
827
mi
from 91732
Portland, OR
Click here to add this to my saved trials
Portsmouth, New Hampshire 03801
2591
mi
from 91732
Portsmouth, NH
Click here to add this to my saved trials
2214
mi
from 91732
Raleigh, NC
Click here to add this to my saved trials
2245
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
2275
mi
from 91732
Rockville, MD
Click here to add this to my saved trials
1354
mi
from 91732
Rogers, AR
Click here to add this to my saved trials
Rolling Hills Estates, California 90274
29
mi
from 91732
Rolling Hills Estates, CA
Click here to add this to my saved trials
1334
mi
from 91732
Saint Joseph, MO
Click here to add this to my saved trials
1573
mi
from 91732
Saint Louis, MO
Click here to add this to my saved trials
570
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
1917
mi
from 91732
Sandy Springs, GA
Click here to add this to my saved trials
26
mi
from 91732
Santa Monica, CA
Click here to add this to my saved trials
2131
mi
from 91732
Savannah, GA
Click here to add this to my saved trials
964
mi
from 91732
Seattle, WA
Click here to add this to my saved trials
South Burlington, Vermont 05403
2469
mi
from 91732
South Burlington, VT
Click here to add this to my saved trials
2136
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
1964
mi
from 91732
Troy, MI
Click here to add this to my saved trials
2472
mi
from 91732
Trumbull, CT
Click here to add this to my saved trials
1253
mi
from 91732
Tulsa, OK
Click here to add this to my saved trials
2419
mi
from 91732
Verona, NJ
Click here to add this to my saved trials
1219
mi
from 91732
Waco, TX
Click here to add this to my saved trials
2281
mi
from 91732
Washington,
Click here to add this to my saved trials
1376
mi
from 91732
Webster, TX
Click here to add this to my saved trials
1698
mi
from 91732
West Dundee, IL
Click here to add this to my saved trials