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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00097370
Registration number
NCT00097370
Ethics application status
Date submitted
22/11/2004
Date registered
23/11/2004
Date last updated
7/07/2017
Titles & IDs
Public title
Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome
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Scientific title
An Open Label Extension Study to Evaluate Safety and Efficacy of Mepolizumab in Patients With Hypereosinophilic Syndromes
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Secondary ID [1]
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100901
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypereosinophilic Syndrome
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Condition category
Condition code
Blood
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Haematological diseases
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - mepolizumab
Experimental: mepolizumab - 750mg Intravenous, monthly and individual dosing schedule
Treatment: Drugs: mepolizumab
Study Drug
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Any Adverse Event (AE) During the Treatment Phase
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Assessment method [1]
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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
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Timepoint [1]
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From the first dose of study medication up to 7 days after the last dose (up to approximately 6 years)
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Primary outcome [2]
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Number of Participants With Any Adverse Event (AE) During the Follow-up Phase
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Assessment method [2]
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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
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Timepoint [2]
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From end of Treatment Phase up to 97 days after the last dose date (up to approximately 6 years)
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Secondary outcome [1]
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Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study
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Assessment method [1]
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Participants who were receiving a prednisone dose level of =<10 mg as their sole background therapy at the end of the study were included for the analysis.
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Timepoint [1]
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up to approximately 6 years
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Secondary outcome [2]
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Number of Participants Achieving an Eosinophil Level of < 600 Cell/Microliter (uL) (in Addition to the Lowest Background Therapy) at the End of Study
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Assessment method [2]
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The criteria for eosinophil count was achieved if the participant's eosinophil count remained below <600 cell/uL for the last observation on study i.e. within length of dosing cycle + 7 days of last dose of study drug. For participants who entered in Stage 1, HES medications taking prior to the first infusion date in Stage 2 were considered as the lowest background therapy. For participants who entered in Stage 2, HES medications taken on the date that immediately preceded the first infusion date of study drug and had not been discontinued was regarded as the lowest background therapy. If the dose of the lowest background therapy had increased or the medication had changed or the participant had not reached their lowest background therapy, the participant was regarded as not achieving this endpoint.
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Timepoint [2]
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up to approximately 6 years
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Secondary outcome [3]
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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
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Assessment method [3]
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Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of <=10 mg of prednisone at study end were analyzed. Duration of doses <=10 mg was determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If it did, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months).
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Timepoint [3]
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up to approximately 6 years
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Secondary outcome [4]
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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
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Assessment method [4]
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Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of prednisone of >10 mg at the end of the study were analyzed. Duration of doses <= 10 mg were determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If overap occurred, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 53 days (8 weeks).
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Timepoint [4]
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up to approximately 6 years
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Secondary outcome [5]
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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;
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Assessment method [5]
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Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of <=10 mg of prednisone at study end and participants who withdrew from the study early who were at a prednisone dose level <=10 mg were analyzed. Duration of doses <= 10 mg were determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If overlap occurred, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months).
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Timepoint [5]
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up to approximately 6 years
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Secondary outcome [6]
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For Those Participants Who Entered Stage 1 From Study MHE100185 With >10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for>=3 Months
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Assessment method [6]
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Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of >10 mg prednisone at the end of the study and participants who withdrew from the study early who were at a prednisone dose level >10 mg were analyzed. Duration of doses <= 10 mg was determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they do not overlap with the steroid dosing dates. If it did, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months)
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Timepoint [6]
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up to approximately 6 years
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Secondary outcome [7]
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Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3
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Assessment method [7]
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Mean blood eosinophil counts were summarized over time taking into account the effect of HES background therapy. Eosinophil count observations for only those participants taking mepolizumab in conjunction with prednisone or as monotherapy were included.
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Timepoint [7]
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up to approximately 6 years
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Secondary outcome [8]
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Number of Participants by Dosing Frequency Groups (Defined as Two Week Dosing Ranges Greater Than a 4 Week Interval) at the End of Stage 2
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Assessment method [8]
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The number of participants at the end of Stage 2 with study medication dosing frequencies of 4 weeks, 5-6 weeks, 7-8 weeks, 9-10 weeks, 11-12 weeks, 13-16 weeks, 17-20 weeks, 21-24 weeks and >24 weeks were summarized. The first infusion date in Stage 3 and the last infusion date in Stage 2 were used to calculate the dosing frequency.
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Timepoint [8]
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up to approximately 6 years
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Secondary outcome [9]
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Change From Baseline in the Pruritus Visual Analogue Scale (pVAS) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter
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Assessment method [9]
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The pruritus visual analogue scale asks participants to rate the status of their Pruritus based on the severity of their itch. Scores range from 0-100 with 0 = No itch and 100 = Worst imaginable itch. Change from Baseline in pVAS score is the difference between the pVAS score at the time point being considered to the MHE100901 Baseline score.
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Timepoint [9]
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Baseline and up to approximately 6 years
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Secondary outcome [10]
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Change From Baseline in Erythema/Edema Score 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter
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Assessment method [10]
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The erythema subscale score and edema subscale score are each graded on a 0-3 scale, with 0 = absent , 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 6, with higher scores indicative of more severe Erythema/Edema. The total score was obtained by summing together the responses for each of the two subscale items. Change from Baseline in erythema/edema total score is the difference between erythema/edema total score at the time point being analyzed to the MHE100901 Baseline score..
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Timepoint [10]
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Baseline and up to approximately 6 years
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Secondary outcome [11]
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Change From Baseline in Quality of Life (QoL) and Current Health Status: Physical Summary Score of the Study Short Form Health Survey (SF-12) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter
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Assessment method [11]
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The SF-12v2 is the 12 item abbreviated form of SF-36v2 survey . It provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. SF-12v2 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS-12) is derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Change from Baseline in scale or summary measure score is the difference between the score at the time point being analyzed to Baseline.
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Timepoint [11]
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Baseline and up to approximately 6 years
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Secondary outcome [12]
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Change From Baseline in QoL and Current Health Status: Mental Summary Score of the SF12 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter
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Assessment method [12]
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The SF-12v2 is the 12 item abbreviated form of SF-36v2 survey developed by the Medical Outcomes Trust and QualityMetric Incorporated. It provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. SF-12v2 scale questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health are for mental component summary. Transformed mental component summary score (MCS-12) is derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Change from Baseline in scale or summary measure score is the difference between the score at the time point being analyzed to Baseline.
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Timepoint [12]
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Baseline and up to approximately 6 years
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Eligibility
Key inclusion 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)
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Minimum age
18
Years
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/09/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/09/2010
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Sample size
Target
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Accrual to date
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Final
78
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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GSK Investigational Site - St Leonards
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Recruitment hospital [2]
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GSK Investigational Site - West Perth
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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6005 - West Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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United States of America
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State/province [3]
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Maryland
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Country [4]
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United States of America
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State/province [4]
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Massachusetts
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Country [5]
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United States of America
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State/province [5]
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Minnesota
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Country [6]
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United States of America
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State/province [6]
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Ohio
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Country [7]
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United States of America
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State/province [7]
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Tennessee
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Country [8]
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United States of America
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State/province [8]
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Utah
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Country [9]
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United States of America
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State/province [9]
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Virginia
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Country [10]
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United States of America
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State/province [10]
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Wisconsin
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Country [11]
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Belgium
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State/province [11]
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Bruxelles
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Country [12]
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Belgium
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State/province [12]
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Leuven
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Country [13]
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Canada
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State/province [13]
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Manitoba
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Country [14]
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Canada
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State/province [14]
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Nova Scotia
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Country [15]
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Canada
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State/province [15]
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Ontario
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Country [16]
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France
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State/province [16]
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Lille
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Country [17]
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France
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State/province [17]
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Suresnes
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Country [18]
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Germany
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State/province [18]
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Bayern
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Country [19]
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Germany
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State/province [19]
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Niedersachsen
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Country [20]
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Germany
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State/province [20]
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Schleswig-Holstein
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Country [21]
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Italy
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State/province [21]
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Emilia-Romagna
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00097370
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00097370
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