A Phase 3, 52-week, open-label, single arm study to investigate the efficacy and safety of mepolizumab SC in participants aged 6 to 17 years with hypereosinophilic syndrome.

Conditions

Hypereosinophilic syndrome (HES)

Brief summary

Frequency of HES flares over the 52-week study treatment period

Detailed description

Change in the mean daily OCS dose (prednisone/prednisolone or equivalent) from Weeks 0 to 4 to Weeks 48 to 52, Reduction of ≥50% in mean daily OCS dose (prednisone/prednisolone or equivalent) from Weeks 0 to 4 compared with Weeks 48 to 52, Achieving a mean daily OCS dose (prednisone/prednisolone or equivalent) of ≤7.5 mg during Weeks 48 to 52, Change from baseline in fatigue severity based on weekly average score of BFI item 3 (worst level of fatigue during past 24 hours) for Week 52, Occurrence of ADA and NAb, Ratio to baseline in absolute blood eosinophil count at discrete time points during the 52-week study treatment period, Mepolizumab plasma concentration at discrete time points during the 52-week study treatment period

Related papers

No related papers found yet.

Interventions

DRUGMEPOLIZUMAB

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Frequency of HES flares over the 52-week study treatment period	—

Secondary

Measure	Time frame
Change in the mean daily OCS dose (prednisone/prednisolone or equivalent) from Weeks 0 to 4 to Weeks 48 to 52, Reduction of ≥50% in mean daily OCS dose (prednisone/prednisolone or equivalent) from Weeks 0 to 4 compared with Weeks 48 to 52, Achieving a mean daily OCS dose (prednisone/prednisolone or equivalent) of ≤7.5 mg during Weeks 48 to 52, Change from baseline in fatigue severity based on weekly average score of BFI item 3 (worst level of fatigue during past 24 hours) for Week 52, Occurrence of ADA and NAb, Ratio to baseline in absolute blood eosinophil count at discrete time points during the 52-week study treatment period, Mepolizumab plasma concentration at discrete time points during the 52-week study treatment period	—

Measure

Time frame

Change in the mean daily OCS dose (prednisone/prednisolone or equivalent) from Weeks 0 to 4 to Weeks 48 to 52, Reduction of ≥50% in mean daily OCS dose (prednisone/prednisolone or equivalent) from Weeks 0 to 4 compared with Weeks 48 to 52, Achieving a mean daily OCS dose (prednisone/prednisolone or equivalent) of ≤7.5 mg during Weeks 48 to 52, Change from baseline in fatigue severity based on weekly average score of BFI item 3 (worst level of fatigue during past 24 hours) for Week 52, Occurrence of ADA and NAb, Ratio to baseline in absolute blood eosinophil count at discrete time points during the 52-week study treatment period, Mepolizumab plasma concentration at discrete time points during the 52-week study treatment period

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Countries

Netherlands, Spain

Outcome results

None listed