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Trial record 1 of 6 for:    atopic dermatitis genentech
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A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03747575
Recruitment Status : Completed
First Posted : November 20, 2018
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This study will assess the efficacy and safety of MSTT1041A (astegolimab) 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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: MSTT1041A Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 6, 2019
Actual Primary Completion Date : March 11, 2020
Actual Study Completion Date : May 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Treatment
Participants will receive MSTT1041A
Drug: MSTT1041A
Participants will receive subcutaneous (SC) MSTT1041A
Other Name: astegolimab

Placebo Comparator: Placebo
Participants will receive placebo matched to MSTT1041A
Drug: Placebo
Participants will receive SC placebo




Primary Outcome Measures :
  1. Percent Change of Total Eczema Area and Severity Index (EASI) Score [ Time Frame: Baseline, Week 16 ]

Secondary Outcome Measures :
  1. Proportion of Participants who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1 [ Time Frame: Baseline, Week 16 ]
  2. Proportion of Participants who Achieve >/=75% Reduction from Baseline in Eczema Area and Severity Index (EASI-75) Score [ Time Frame: Baseline, Week 16 ]
  3. Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 16 ]
  4. Percent Change in Body Surface Area (BSA) with Atopic Dermatitis (AD) Involvement [ Time Frame: Baseline, Week 16 ]
  5. Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) [ Time Frame: Baseline, Week 16 ]
  6. Percentage of Participants with Adverse Events (AE) [ Time Frame: Up to Week 24 ]
  7. Serum Concentrations of MSTT1041A [ Time Frame: At pre-defined intervals from baseline up to Week 24 ]
  8. Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs) [ Time Frame: Up to Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747575


Locations
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United States, Alabama
Alabama Allergy & Asthma
Birmingham, Alabama, United States, 35209
United States, California
California Allergy and Asthma Medical Group - CRN
Los Angeles, California, United States, 90025
Jonathan Corren MD, Inc.
Los Angeles, California, United States, 90025
United States, Colorado
Asthma & Allergy; Associates, P.C.
Colorado Springs, Colorado, United States, 80907
United States, Florida
South Coast Research Center, Inc.
Miami, Florida, United States, 33136
Harmony Clinical Research, Inc
North Miami Beach, Florida, United States, 33162
GCP Global Clinical Professionals
Saint Petersburg, Florida, United States, 33702
Forward Clinical Trials
Tampa, Florida, United States, 33624
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, United States, 32789
United States, Illinois
Midwest Sinus Allergy and Asthma - CRN
Normal, Illinois, United States, 61761
United States, Kentucky
Dermatology Specialists Research, LLC
Louisville, Kentucky, United States, 40241
United States, Nevada
Clinical Research Consortium Nevada
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Skin Laser and Surgery Specialists of New York and New Jersey LLC - Interspond - PPDS
Hackensack, New Jersey, United States, 07601
United States, Oklahoma
Vital Prospects Clinical Research Institute PC - CRN
Tulsa, Oklahoma, United States, 74136
United States, Texas
Center for Clinical Studies
Houston, Texas, United States, 77004
Germany
Charite - Universitätsmedizin Berlin
Berlin, Germany, 12203
Universitätsklinikum Münster
Münster, Germany, 48149
Poland
Centrum Medyczne ALL-MED
Krakow, Poland, 30-033
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, Poland, 90-153
Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina; Klinika Dermatologii
Rzeszow, Poland, 35-055
Laser Clinic
Szczecin, Poland, 70-322
Wro Medica
Wrocław, Poland, 51-685
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03747575    
Other Study ID Numbers: GS40965
2018-003429-27 ( EudraCT Number )
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com).

Further details on Roche's criteria for eligible studies are available here: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases