A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis
NCT ID: NCT03747575
Last Updated: 2023-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2019-02-06
2020-05-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment
Participants will receive MSTT1041A
MSTT1041A
Participants will receive subcutaneous (SC) MSTT1041A
Placebo
Participants will receive placebo matched to MSTT1041A
Placebo
Participants will receive SC placebo
Interventions
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MSTT1041A
Participants will receive subcutaneous (SC) MSTT1041A
Placebo
Participants will receive SC placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Alabama Allergy & Asthma
Birmingham, Alabama, United States
California Allergy and Asthma Medical Group - CRN
Los Angeles, California, United States
Jonathan Corren MD, Inc.
Los Angeles, California, United States
Asthma & Allergy; Associates, P.C.
Colorado Springs, Colorado, United States
South Coast Research Center, Inc.
Miami, Florida, United States
Harmony Clinical Research, Inc
North Miami Beach, Florida, United States
GCP Global Clinical Professionals
St. Petersburg, Florida, United States
Forward Clinical Trials
Tampa, Florida, United States
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, United States
Midwest Sinus Allergy and Asthma - CRN
Normal, Illinois, United States
Dermatology Specialists Research, LLC
Louisville, Kentucky, United States
Clinical Research Consortium Nevada
Las Vegas, Nevada, United States
Skin Laser and Surgery Specialists of New York and New Jersey LLC - Interspond - PPDS
Hackensack, New Jersey, United States
Vital Prospects Clinical Research Institute PC - CRN
Tulsa, Oklahoma, United States
Center for Clinical Studies
Houston, Texas, United States
Universitatsklinikum Munster
Münster, , Germany
Centrum Medyczne ALL-MED
Krakow, , Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina; Klinika Dermatologii
Rzeszów, , Poland
Laser Clinic
Szczecin, , Poland
Wro Medica
Wroc?aw, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-003429-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS40965
Identifier Type: -
Identifier Source: org_study_id
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