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

Purpose

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.

Condition	Intervention	Phase
Hypereosinophilic Syndrome	Drug: mepolizumab	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Extension Study to Study MHE100185, to Evaluate Long-term Safety, Efficacy and Optimal Dosing Frequency of 750 mg Intravenous Mepolizumab in Subjects With Hypereosinophilic Syndromes

Resource links provided by NLM:

Genetics Home Reference related topics: PDGFRA-associated chronic eosinophilic leukemia PDGFRB-associated chronic eosinophilic leukemia

MedlinePlus related topics: Steroids

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Frequency of all Adverse Events [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

- Describe maintenance of durable effect on prednisone dose level. - Describe durable effect in reducing blood eosinophil count. - Optimal dosing frequency of mepolizumab. - Quality of life measures. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Proportion of subjects achieving a prednisone level of ≤10mg (as sole background therapy) at the end of study MHE100901 [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Proportion of subjects achieving an eosinophil level of < 600cell/ul (in addition to the lowest background HES therapy) at the end of study MHE100901 [ Time Frame: 6 years ] [ Designated as safety issue: No ]
For those subjects who completed 9 months of dosing in study MHE100185 and achieved a prednisone level ≤10mg ; the proportion of subjects achieving ≤ 10mg prednisone (as sole background therapy) for ≥ 3months [ Time Frame: 6 years ] [ Designated as safety issue: No ]
For those subjects who completed 9 months of dosing in study MHE100185 and achieved a prednisone level > 10mg at the end of Study MHE100185; the proportion of subjects achieving ≤10mg prednisone (as sole background therapy) for ≥ 8 weeks [ Time Frame: 6 years ] [ Designated as safety issue: No ]
For those subjects who entered stage 2 from study MHE100185 with a prednisone level of ≤10mg prednisone; the proportion of subjects achieving a prednisone dose ≤10mg (as sole background therapy) for ≥3 months [ Time Frame: 6 years ] [ Designated as safety issue: No ]
For those subjects who entered stage 1 from study MHE100185 with >10mg prednisone; the proportion of subjects achieving a prednisone dose ≤10mg (as sole background therapy) for≥3 months [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Blood eosinophil count (with consideration of their HES background therapy) during Stages 1-3 [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Proportion of subjects by dosing frequency groups (defined as two week dosing ranges greater than a 4 week interval) at the end of Stage 2 [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Pruritus visual analogue scale (pVAS) 3 months after the start of study MHE100901 and every 6 months thereafter [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Erythema/edema score 3 months after the start of study MHE100901 and every 6 months thereafter [ Time Frame: 6 years ] [ Designated as safety issue: No ]
QoL and current health status: physical summary score of the SF12TM 3 months after the start of study MHE100901 and every 6 months thereafter [ Time Frame: 6 years ] [ Designated as safety issue: No ]
QoL and current health status: mental summary score of the SF12TM 3 months after the start of study MHE100901 and every 6 months thereafter [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Enrollment:	78
Study Start Date:	September 2004
Study Completion Date:	September 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: mepolizumab 750mg Intravenous, monthly and individual dosing schedule	Drug: mepolizumab Other Name: mepolizumab

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

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)

Exclusion criteria:

Has developed life-threatening or other serious illness or clinical manifestation deemed inappropriate for inclusion in study per the principal investigator
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097370

Show 23 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00097370 History of Changes
Other Study ID Numbers:	100901
Study First Received:	November 22, 2004
Last Updated:	November 1, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

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

Additional relevant MeSH terms:

Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013