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
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...
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27800 Medical Center Road
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New Albany, Indiana 47150
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