A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis



Status:Recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:3/10/2019
Start Date:February 18, 2019
End Date:March 31, 2020
Contact:Reference Study ID Number: GS40965 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase II, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of MSTT1041A in Patients With Moderate to Severe Atopic Dermatitis

This study will assess the efficacy and safety of MSTT1041A in participants with moderate to
severe atopic dermatitis (AD). The study consists of a screening period, a 16-week treatment
period, and an 8-week follow-up period.


Inclusion criteria

- Ability to comply with the study protocol

- Chronic AD that has been present for at least 3 years before the screening visit

- Documented recent history (within 6 months before the screening visit) of inadequate
response to treatment with topical medications (medications or treatments applied
directly to part of the body) or for whom topical treatments are otherwise medically
inadvisable

Exclusion criteria

- Prior treatment with MSTT1041A

- Treatment with any investigational therapy (with the exception of biologics) within 8
weeks or within 5 half-lives whichever is longer, before screening

- Treatment with any cell-depleting agents within 6 months before screening, or until
lymphocyte count returns to normal, whichever is longer

- Treatment with other biologics within 3 months or 5 half-lives before screening,
whichever is longer

- Comorbid conditions that may interfere with evaluation of investigational medicinal
product

- History or evidence of substance abuse that would pose a risk to participant safety,
interfere with the conduct of the study, have an impact on the study results, or
affect the participant's ability to participate in the study

- History of anaphylaxis, hypersensitivity to a biologic agent, or known
hypersensitivity to any component of the MSTT1041A or placebo injection

- Planned surgical intervention during the course of the study

- Pregnant or breastfeeding, or intending to become pregnant during the study

- Participant who is a member of the investigational team or his/her immediate family
We found this trial at
24
sites
3810 Springhurst Boulevard
New Albany, Indiana 47150
177
mi
from 43215
New Albany, IN
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4334
mi
from 43215
Berlin,
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Birmingham, Alabama 35209
491
mi
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Birmingham, AL
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Charlotte, North Carolina 28277
348
mi
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Charlotte, NC
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Colorado Springs, Colorado 80907
1162
mi
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Colorado Springs, CO
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?
mi
from 43215
Hackensack, NJ
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Houston, Texas 77030
995
mi
from 43215
Houston, TX
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Las Vegas, Nevada 89119
1756
mi
from 43215
Las Vegas, NV
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
609
mi
from 43215
Lebanon, NH
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?
mi
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Los Angeles, CA
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Los Angeles, California 90025
1972
mi
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Los Angeles, CA
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Louisville, Kentucky 40202
188
mi
from 43215
Louisville, KY
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Miami, Florida 33136
993
mi
from 43215
Miami, FL
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27800 Medical Center Road
Mission Viejo, California 92691
1954
mi
from 43215
Mission Viejo, CA
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?
mi
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Normal, IL
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North Miami Beach, Florida 33162
983
mi
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North Miami Beach, FL
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Palm Springs, California 92262
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Palm Springs, CA
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Richmond, Virginia
344
mi
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Richmond, VA
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Saint Petersburg, Florida 33702
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Saint Petersburg, FL
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San Antonio, Texas 78258
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San Antonio, TX
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Santa Monica, California 90404
1984
mi
from 43215
Santa Monica, CA
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Tampa, Florida 33624
820
mi
from 43215
Tampa, FL
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752
mi
from 43215
Tulsa, OK
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Winter Park, Florida 32789
791
mi
from 43215
Winter Park, FL
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