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NCT03055195 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety Study of Mepolizumab in Subjects With Moderate to Severe Atopic Dermatitis

A Phase 2 study, sponsored by GlaxoSmithKline.

Terminated
Registry status
Phase 2
Development phase
34
Enrollment target

NCT03055195 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 34 participants.

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The verdict

NCT03055195, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.

TERMINATED
Registry status
Phase 2
Development phase
34 participants
Enrollment target

Study Summary

Mepolizumab is a humanized Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that acts on Interleukin-5 (IL-5), which is responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils; thereby reducing the production and survival of eosinophils which may be therapeutic in subjects with atopic dermatitis (AD). This study will investigate the efficacy and safety of mepolizumab (100 milligram \[mg\] subcutaneous \[SC\] administered every 4 weeks) compared with placebo in adult subjects with moderate to severe atopic dermatitis (AD). Subjects will be randomized 1:1 to either placebo SC or mepolizumab SC. The study will comprise of a pre-screening period of up to approximately 4 weeks, a screening period of up to 2 weeks, followed by a 16-Week study treatment period (16 weeks with the last dose of study treatment at Week 12) and follow-up period of up to 4-week. The total duration of subject participation will be approximately 26 weeks. (Note: For subjects, who may need to stop treatment with a biologic, the total Pre-Screening and Screening period may last up to 20 weeks and total duration of participation in the study may be up to 40 weeks).

Interventions

  • DRUG Placebo matching mepolizumab
  • DRUG Mepolizumab 100 mg

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2017-03-21
Est. Completion 2017-12-06
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT03055195

The ClinicalTrials.gov registry entry for NCT03055195 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo matching mepolizumab is the first listed.

NCT03055195 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03055195 about?

NCT03055195 is a clinical study titled "Efficacy and Safety Study of Mepolizumab in Subjects With Moderate to Severe Atopic Dermatitis". Mepolizumab is a humanized Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that acts on Interleukin-5 (IL-5), which is responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils; thereby reducing the production and survival of eosinophils which may be the...

What is the current status of trial NCT03055195?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2017-03-21. Estimated completion is 2017-12-06.

What interventions are being tested in trial NCT03055195?

The interventions under investigation include: Placebo matching mepolizumab (DRUG), Mepolizumab 100 mg (DRUG).

Who is sponsoring clinical trial NCT03055195?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.