Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome

NCT00097370 | Terminated Phase 3 Results

• 1 other identifier: 100901
• Study Type: interventional
• Target: 78
• Locations: 7 countries
• Sites: 24

Brief Summary

This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome.

Conditions

Hypereosinophilic Syndrome

Keywords

Mepolizumab; Open-label; Anti-IL-5; Hypereosinophilic Syndrome; Hypereosinophilia

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Any Adverse Event (AE) During the Treatment Phase

  An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Treatment phase. Safety and tolerability of the study drug was assessed by number of participants with any AE

  From the first dose of study medication up to 7 days after the last dose (up to approximately 6 years)

• Number of Participants With Any Adverse Event (AE) During the Follow-up Phase

  An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Follow-up phase. Safety and tolerability of the study drug was assessed by number of participants with any AE

  From end of Treatment Phase up to 97 days after the last dose date (up to approximately 6 years)

Secondary Outcomes (12)

• Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study

  up to approximately 6 years

• Number of Participants Achieving an Eosinophil Level of < 600 Cell/Microliter (uL) (in Addition to the Lowest Background Therapy) at the End of Study

  up to approximately 6 years

• For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level <=10 mg: Number of Participants Achieving <= 10 mg Prednisone (as Sole Background Therapy) for >= 3months

  up to approximately 6 years

• For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level >10 mg: Number of Participants Achieving <=10 mg Prednisone (as Sole Background Therapy) for >= 8 Weeks

  up to approximately 6 years

• For Those Participants Who Entered Stage 2 From Study MHE100185 With a Prednisone Level of <=10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for >=3 Months;

  up to approximately 6 years

Study Arms (1)

mepolizumab

EXPERIMENTAL

750mg Intravenous, monthly and individual dosing schedule

Drug: mepolizumab

Interventions

mepolizumab DRUG

Study Drug

mepolizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Subjects who have participated in Study MHE100185 and have been administered at least 2 doses of study medication.
• Not pregnant or nursing
• Of non-childbearing potential (i.e., women who had a hysterectomy, are post-menopausal which is defined as 1 year without menses, have both ovaries surgically removed, or have current documented tubule ligation); or
• Of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea \[even severe\], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at the Screening Visit, and agree to one of the following:1). Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of investigational product until 3 months after the last dose of investigational product; Or 2). Consistent and correct use of one of the following acceptable methods of birth control for one month prior to the start of the investigation product and three months after the last dose:Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subjects; Implants of levonorgestrel;Injectable progestogen;Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; Oral contraceptives (either combined or progestogen only)

You may not qualify if:

• Has any of the following abnormal laboratory values at the Week36/EW Visit of Study MHE100185: • Serum creatinine ≥3 times institutional upper limit normal (ULN); • AST or/ALT ≥5 times institutional ULN; • Platelet count \< 50,000/uL
• Has developed abnormal cardiac functions, as the following, within past 3 months:• Left ventricular ejection fraction (LVEF) \< 20%; • NYHA class IIIb or IV; • Angina or acute myocardial infarction
• Has developed allergic reaction to Study MHE100185 investigational product Use of an investigational drug as concurrent medication
• Does not complete Week36/EW Visit assessments required in Study MHE100185
• Has completed or been terminated from Study MHE100185 for more than 1 month
• Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months
• Positive pregnancy test at the Week36/EW Visit of Study MHE100185

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (24)

GSK Investigational Site

San Diego, California, 92103, United States

Location

GSK Investigational Site

Denver, Colorado, 80206, United States

Location

GSK Investigational Site

Bethesda, Maryland, 20892, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

Rochester, Minnesota, 55905, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45229, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203-1424, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84132, United States

Location

GSK Investigational Site

Richmond, Virginia, 23298, United States

Location

GSK Investigational Site

Madison, Wisconsin, 53705, United States

Location

GSK Investigational Site

St Leonards, New South Wales, 2065, Australia

Location

GSK Investigational Site

West Perth, Western Australia, 6005, Australia

Location

GSK Investigational Site

Brussels, 1070, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Winnipeg, Manitoba, R3C 0N2, Canada

Location

GSK Investigational Site

Halifax, Nova Scotia, B3H 1V7, Canada

Location

GSK Investigational Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5V 2T3, Canada

Location

GSK Investigational Site

Lille, 59000, France

Location

GSK Investigational Site

Suresnes, 92150, France

Location

GSK Investigational Site

Munich, Bavaria, 80802, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

GSK Investigational Site

Bad Bramstedt, Schleswig-Holstein, 24576, Germany

Location

GSK Investigational Site

Bologna, Emilia-Romagna, 40138, Italy

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Hypereosinophilic Syndrome; Eosinophilia

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2004
• First Posted: November 23, 2004
• Study Start: September 30, 2004
• Primary Completion: September 29, 2010
• Study Completion: September 29, 2010
• Last Updated: July 7, 2017
• Results First Posted: December 15, 2015

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

DE (3); IT (1); CA (4); BE (2); FR (2); US (10); AU (2)