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

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ClinicalTrials.gov Identifier: NCT03747575
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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
Estimated Primary Completion Date : December 21, 2019
Estimated Study Completion Date : December 21, 2019

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

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 ]


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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


Contacts
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Contact: Reference Study ID Number: GS40965 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

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Locations
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United States, Alabama
Alabama Allergy & Asthma Recruiting
Birmingham, Alabama, United States, 35209
United States, California
California Allergy and Asthma Medical Group - CRN Recruiting
Los Angeles, California, United States, 90025
Jonathan Corren MD, Inc. Recruiting
Los Angeles, California, United States, 90025
Palmtree Clinical Research - ClinEdge - PPDS Recruiting
Palm Springs, California, United States, 92262
Clinical Science Institute Recruiting
Santa Monica, California, United States, 90404
United States, Colorado
Asthma & Allergy; Associates, P.C. Recruiting
Colorado Springs, Colorado, United States, 80907
United States, Florida
South Coast Research Center, Inc. Recruiting
Miami, Florida, United States, 33136
Harmony Clinical Research, Inc Recruiting
North Miami Beach, Florida, United States, 33162
GCP Global Clinical Professionals Recruiting
Saint Petersburg, Florida, United States, 33702
Forward Clinical Trials Recruiting
Tampa, Florida, United States, 33624
Florida Pulmonary Research Institute, LLC Recruiting
Winter Park, Florida, United States, 32789
United States, Illinois
Midwest Sinus Allergy and Asthma - CRN Recruiting
Normal, Illinois, United States, 61761
United States, Indiana
DS Research Recruiting
New Albany, Indiana, United States, 47150
United States, Kentucky
Dermatology Specialists Research, LLC Recruiting
Louisville, Kentucky, United States, 40241
United States, Nevada
Clinical Research Consortium Nevada Recruiting
Las Vegas, Nevada, United States, 89119
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Skin Laser and Surgery Specialists of New York and New Jersey LLC - Interspond - PPDS Recruiting
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Clinical Research of Charlotte Recruiting
Charlotte, North Carolina, United States, 28277
United States, Oklahoma
Vital Prospects Clinical Research Institute PC - CRN Recruiting
Tulsa, Oklahoma, United States, 74136
United States, Texas
Austin Institute for Clinical Research, Inc. - Dripping Springs Recruiting
Dripping Springs, Texas, United States, 78620
Center for Clinical Studies Recruiting
Houston, Texas, United States, 77004
Grey Canyon Family Medicine PA Recruiting
San Antonio, Texas, United States, 78258
United States, Virginia
Clinical Research Partners, LLC Recruiting
Richmond, Virginia, United States, 23220
Germany
Charite - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 12203
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik fur Dermatologie Recruiting
Dresden, Germany, 01307
Universitatsklinikum Frankfurt Recruiting
Frankfurt, Germany, 60590
Medizinische Hochschule Hannover Not yet recruiting
Hannover, Germany, 30625
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Poland
Centrum Medyczne ALL-MED Recruiting
Krakow, Poland, 30-033
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi Recruiting
Lodz, Poland, 90-153
Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina; Klinika Dermatologii Recruiting
Rzeszow, Poland, 35-055
Laser Clinic Recruiting
Szczecin, Poland, 70-322
Twoja Przychodnia-Szczecinskie Centrum Medyczne Withdrawn
Szczecin, Poland, 71-270
Wro Medica Recruiting
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     History of Changes
Other Study ID Numbers: GS40965
2018-003429-27 ( EudraCT Number )
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

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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
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases