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

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT03747575

Run by

Genentech, Inc.

People needed

65

Starts

2019-02-06

Expected to finish

2020-05-05

Last updated by the study team

2023-05-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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