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

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Basic Details

Gender

All

Age

≥ 18 Years & ≤ 75 Years

Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 2

Study Identifier NCT03747575, GS40965, 2018-003429-27

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.

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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Basic Details

Sponsor Genentech, Inc.

Phase Phase 2

Study Identifier NCT03747575, GS40965, 2018-003429-27

Condition Atopic Dermatitis

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

Study 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.

Eligibility Criteria

Gender

All

Age

≥ 18 Years & ≤ 75 Years

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

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

A study to look at the effects of a new medicine (astegolimab) in comparison to placebo - in patients with eczema (atopic dermatitis)

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

Study results

LPS_GS40965_ZARNIE_final results_November2020_English (PDF, 0.2 MB)

LPS_GS40965_ZARNIE_final results_November2020_German_Germany (PDF, 0.2 MB)

LPS_GS40965_ZARNIE_final results_November2020_Polish_Poland (PDF, 0.2 MB)

LPS_GS40965_ZARNIE_final results_November2020_Spanish_USA (PDF, 0.2 MB)

What is Clinical Research?

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Find participating medical centers and current study status in each of them

A study to look at the effects of a new medicine (astegolimab) in comparison to placebo - in patients with eczema (atopic dermatitis)

Basic Details

What you can do next

Find participating medical centers and current study status in each of them

Explore related studies

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com