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A study to look at the effects of a new medicine (astegolimab) in comparison to placebo - in patients with eczema (atopic dermatitis)
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis
- Autoimmune Disorder
- Atopic Dermatitis
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Countries
- Germany
- Poland
- United States
Trial Identifier:
NCT03747575 2018-003429-27 GS40965
Trial 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.
Genentech, Inc.
Sponsor
Phase 2
Phase
NCT03747575, GS40965, 2018-003429-27
Trial Identifier
All
Gender
≥ 18 Years & ≤ 75 Years
Age
No
Healthy Volunteers
This clinical trial was done to study a new medicine called, “astegolimab”, for the treatment of patients with “eczema (atopic dermatitis)”. This study was done to find out if astegolimab – a new medicine – was effective for treating patients with a certain type of eczema (atopic dermatitis). Sixty-five patients took part in this study at 21 study centers in 3 countries.
Trial 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.
Genentech, Inc.
Sponsor
Phase 2
Phase
NCT03747575, GS40965, 2018-003429-27
Trial Identifier
MSTT1041A, Placebo
Treatments
Atopic Dermatitis
Condition
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
Eligibility Criteria
All
Gender
≥ 18 Years & ≤ 75 Years
Age
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com