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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03306043
Recruitment Status : Completed
First Posted : October 10, 2017
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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participate in this extension study if they had completed the 32-Week treatment period in study 200622 or if they were withdrawn from the study pre-maturely, but were continued in the study per protocol until 32 Weeks from randomization.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.

Condition or disease Intervention/treatment Phase
Hypereosinophilic Syndrome Drug: Mepolizumab Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A single group of subjects will receive 300 mg SC mepolizumab every 4 Weeks.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-centre, Open-label Extension, Safety Study to Describe the Long-term Clinical Experience of Mepolizumab in Participants With Hypereosinophilic Syndrome (HES) From Study 200622
Actual Study Start Date : November 13, 2017
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : December 30, 2019


Arm Intervention/treatment
Experimental: 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.
Drug: 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.




Primary Outcome Measures :
  1. Number of subjects with Non-Serious Adverse events (AEs) and Serious AEs (SAE) [ Time Frame: Up to 28 Weeks ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

  2. Number of subjects with the presence of anti-drug antibody [ Time Frame: Up to 28 Weeks ]
    Blood samples will be collected at specified time points and samples will be analyzed for the presence of anti-mepolizumab antibodies.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306043


Locations
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United States, California
GSK Investigational Site
La Jolla, California, United States, 92093
United States, Connecticut
GSK Investigational Site
New Haven, Connecticut, United States, 06520
United States, Minnesota
GSK Investigational Site
Rochester, Minnesota, United States, 55905
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
GSK Investigational Site
Mayfield Heights, Ohio, United States, 44124
United States, Utah
GSK Investigational Site
Murray, Utah, United States, 84107
Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1028AAP
GSK Investigational Site
La Plata, Buenos Aires, Argentina
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, 7600
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1070
GSK Investigational Site
Leuven, Belgium, 3000
Brazil
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 40110-160
GSK Investigational Site
Santo André - SP, São Paulo, Brazil, 09080-110
GSK Investigational Site
Sorocaba, São Paulo, Brazil, 18040-425
France
GSK Investigational Site
Lille Cedex, France, 59037
GSK Investigational Site
Nantes Cedex 1, France, 44093
GSK Investigational Site
Suresnes, France, 92151
GSK Investigational Site
Toulouse Cedex 9, France, 31059
Germany
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
GSK Investigational Site
Fulda, Hessen, Germany, 36043
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Kirchheim unter Teck, Germany, 73230
Italy
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
Firenze, Toscana, Italy, 50134
Mexico
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44100
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64060
GSK Investigational Site
Villahermosa, Tabasco, Mexico, 86035
Poland
GSK Investigational Site
Krakow, Poland, 31-066
GSK Investigational Site
Lodz, Poland, 90-153
Romania
GSK Investigational Site
Bucharest, Romania, 010306
GSK Investigational Site
Targu Mures, Romania, 540327
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 125167
GSK Investigational Site
Saint-Petersburg, Russian Federation, 197341
Spain
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Valencia, Spain, 46026
United Kingdom
GSK Investigational Site
Leicester, United Kingdom, LE3 9QP
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03306043    
Other Study ID Numbers: 205203
2017-000184-32 ( EudraCT Number )
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
hypereosinophilic syndrome
hypereosinophilic syndrome flare
open-label extension study
Mepolizumab
SB240563
Long-term safety
Additional relevant MeSH terms:
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Hypereosinophilic Syndrome
Syndrome
Disease
Pathologic Processes
Eosinophilia
Leukocyte Disorders
Hematologic Diseases