A Multi-center, Open-label Extension, Safety Study of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES) From Study 200622

NCT ID: NCT03306043

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-13
• Study Completion Date: 2019-12-30

Brief Summary

This is an open-label extension study to Study 200622.In this study subjects from Study 200622 will be continued on 4-weekly dosing with open-label mepolizumab 300 milligram (mg) subcutaneously (SC) for an additional 20 Weeks after completing the 32 Week study assessments post-randomization, while they continue with their background HES therapy per standard of care (SoC). Subjects from study 200622 will participate in this extension study if they had completed the 32-Week treatment period in study 200622 or if they were withdrawn from the study pre-maturely, but were continued in the study per protocol until 32 Weeks from randomization. Data from this study (205203) and 200622 will be combined to provide up to 52-Week exposure data to further characterize the long-term safety profile of mepolizumab and provide additional data on the clinical benefit in HES subjects beyond 32 Weeks. The duration of the study participation will be 20 Weeks for subjects who continue with mepolizumab treatment via MHE104317/MHE112562 after this open-label extension study; and 28 Weeks for subjects who do not continue with MHE104317/MHE112562.

Conditions

Hypereosinophilic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects who received mepolizumab

Subjects who were part of study 200622 and were randomized to receive either placebo or mepolizumab will be enrolled in this study as per study eligibility criteria. In this study, subjects will receive 300 mg of mepolizumab SC (three 100 mg SC injections) every 4 Weeks for a total of 5 doses during 20-Week treatment period.

Group Type: EXPERIMENTAL

Mepolizumab

Intervention Type: DRUG

Mepolizumab will be available as 100 mg vial for injection. Subjects will receive three 100 mg SC injections for every 4 Weeks for a total of 5 doses during 20 Week treatment period.

Interventions

Mepolizumab

Mepolizumab will be available as 100 mg vial for injection. Subjects will receive three 100 mg SC injections for every 4 Weeks for a total of 5 doses during 20 Week treatment period.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 12 years and older subjects who were enrolled in Study 200622.
• To be considered for Study 205203, subjects from study 200622 must have completed 32-Week treatment period in the study or if the subject was withdrawn from study treatment prematurely during the 200622 study, but continued in the study per protocol (including HES flare-related assessments) until 32 Weeks from randomization.
• Male or female subjects. Female subjects must be either not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance at least 30 days prior to the first dose of study treatment and until 16 weeks after the last dose of study treatment.
• The treating physician must confirm a positive benefit/risk ratio. The anticipated clinical benefit from mepolizumab must outweigh any potential safety or tolerability risk in Study 205203.
• Capable of giving signed informed consent.

Exclusion Criteria

• Subjects with any history of hypersensitivity to any monoclonal antibody (including mepolizumab).
• Subjects with current malignancy or malignancy that developed during Study 200622.
• Subjects who is pregnant or breastfeeding.
• Subjects who has other clinically significant medical conditions uncontrolled with SoC therapy not associated with HES, example (e. g.), unstable liver disease, uncontrolled cardiovascular disease, ongoing active infectious disease.
• Subjects with QT interval corrected (QTc) greater than 450 millisecond (msec) or QTc greater than 480 msec in subjects with bundle branch block based on local Electrocardiogram (EGC) reading.
• Subjects who discontinue study treatment based on liver chemistry stopping criteria during Study 200622.
• Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
• Subjects who have received treatment with an investigational agent (biologic or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer, prior to the first dose, other than Study 200622 study treatment. The term "investigational" applies to any drug not approved for sale for the disease/indication to treat in the country in which it is being used or investigational formulations of marketed products.
• Subjects who are currently participating in any other interventional clinical study.
• Subjects had an AE (serious or non-serious) considered related to study treatment while participating in Study 200622 which resulted in permanent withdrawal of study treatment.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

La Jolla, California, United States

GSK Investigational Site

New Haven, Connecticut, United States

GSK Investigational Site

Rochester, Minnesota, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Mayfield Heights, Ohio, United States

GSK Investigational Site

Murray, Utah, United States

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

La Plata, Buenos Aires, Argentina

GSK Investigational Site

Mar del Plata, Buenos Aires, Argentina

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

GSK Investigational Site

Santo André - SP, São Paulo, Brazil

GSK Investigational Site

Sorocaba, São Paulo, Brazil

GSK Investigational Site

Lille, , France

GSK Investigational Site

Nantes, , France

GSK Investigational Site

Suresnes, , France

GSK Investigational Site

Toulouse, , France

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Fulda, Hesse, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Kirchheim unter Teck, , Germany

GSK Investigational Site

Napoli, Campania, Italy

GSK Investigational Site

Florence, Tuscany, Italy

GSK Investigational Site

Guadalajara, Jalisco, Mexico

GSK Investigational Site

Monterrey, Nuevo León, Mexico

GSK Investigational Site

Villahermosa, Tabasco, Mexico

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Lodz, , Poland

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Târgu Mureş, , Romania

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Leicester, , United Kingdom

Countries

United States; Argentina; Belgium; Brazil; France; Germany; Italy; Mexico; Poland; Romania; Russia; Spain; United Kingdom

References

Gleich GJ, Roufosse F, Chupp G, Faguer S, Walz B, Reiter A, Yancey SW, Bentley JH, Steinfeld J; HES Mepolizumab Study Group. Safety and Efficacy of Mepolizumab in Hypereosinophilic Syndrome: An Open-Label Extension Study. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4431-4440.e1. doi: 10.1016/j.jaip.2021.07.050. Epub 2021 Aug 10.

Reference Type: DERIVED

PMID: 34389506 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-000184-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205203

Identifier Type: -

Identifier Source: org_study_id