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. - Study in Paediatrics with HypEREosinophilic syndrome (SPHERE)

GlaxoSmithKline0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年4月9日

试验速览

阶段: 3 期
状态: 尚未招募
发起方: GlaxoSmithKline
入组人数: 3

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 2 至 17（—）

入选标准

•1. Participant must be aged 6 to 17 years inclusive, at Screening (Visit 1);
•Type of Participant and Disease Characteristics:
•2. Participants who have been diagnosed with HES for at least 6 months prior to
•enrolment (Visit 2);
•3. A history of 2 or more HES flares within the past 12 months prior to
•Screening (Visit 1);
•4. Participants must have blood eosinophil count >=1000 cells/µL present at
•5. Participants must be on a stable dose of HES therapy for the 4 weeks prior
•to the first dose of mepolizumab (Visit 2);
•Sex and Contraceptive/Barrier Requirements:
•6. Male and/or female [(according to their reproductive organs and functions
•assigned by chromosomal complement)] [FDA, 2016].
•Contraception and barriers as well as pregnancy testing is required as
•appropriate for the age and sexual activity of paediatric participants and as
•required by local regulations.
•A female participant is eligible to participate if she is either:
•Premenarcheal or
•Not pregnant as confirmed by a negative urine (or serum if required by local
•regulations) human chorionic gonadotrophin [hCG] test if of reproductive
•Females of childbearing potential must commit to consistent and correct use of
•an acceptable method of contraception (see Section 10.4, Appendix 4 of the
•study protocol) for the duration of the trial and 16weeks after the last dose
•of investigational product. A urine pregnancy test is required of females of
•childbearing potential.
•Informed Consent and Assent
•7. The investigator, or a person designated by the investigator, will obtain
•written informed consent from each study participant's (legal guardian as
•defined in Section 10.1.3 of the study protoocol) and the participant's assent,
•when applicable, before any study-specific activity is performed (unless a
•waiver of informed consent has been granted by an Institutional Review Board
•[IRB]/Ethics Committee [EC]). All legal guardians should be fully informed, and
•participants should be informed to the fullest extent possible, about the study
•in language and terms they are able to understand.
•8. The participant capable of providing signed and dated written assent signs
•and dates a written assent form (age appropriate) and the parent/guardian signs
•and dates a written informed consent form (ICF) for study participation prior
•to the initiation of any study-related activities.
•9. A legal guardian or primary caregiver must be available to help the
•study-site personnel ensure follow-up; support the participant to attended
•assessment days according to the SoA (e.g., able to comply with scheduled
•visits, treatment plan, laboratory tests, and other study procedures);
•consistently and consecutively be available to provide information on the
•participant using the rating scales during the scheduled study visits;
•accurately and reliably dispense study intervention as directed.

排除标准

•Medical Conditions:
•1. Life-threatening HES or life-threatening HES co-morbidities:
•Imminently life threatening HES disease severity such that (a) likelihood of
•death is high unless the course of the disease is interrupted within 12 weeks
•prior to Visit 2 (b) likelihood of severe deterioration of HES is high unless
•immediate therapeutic intervention is provided.
•2. Other concurrent medical conditions that may affect the participant's safety:
•Participants who have known, pre-existing, clinically significant endocrine,
•autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic,
•haematological, respiratory, or any other system abnormalities that are not
•associated with HES and are uncontrolled with standard
•3. Eosinophilia of unknown significance
•4. FIP1L1-PDGFRa (F/P) Status: Participants who test positive for F/P
•5. Clinical diagnosis of EGPA
•6. Infection:
•Participants with chronic or ongoing active infections requiring systemic
•treatment, as well as participants who have experienced clinically significant
•infections due to viruses, bacteria, and fungi within 4 weeks prior to
•enrolment (Visit 2).
•Participants with a pre-existing parasitic infestation within 6 months prior
•to enrolment (Visit 2).
•7. Participants with a known immunodeficiency (e.g., HIV), other than that
•explained by the use of OCS or other therapy taken for HES.
•8. Participants with documented history of any clinically significant cardiac
•damage prior to Screening (Visit 1) that, in the opinion of the investigator,
•would impact the participant's participation during the study.
•9. Malignancy:
•Participants with a history of or current lymphoma
•Participants with current malignancy or previous history of cancer in
•remission for less than 12 months prior to Screening (Visit 1).
•Participants that had localised carcinoma (i.e., basal or squamous cell) of the
•skin that was resected for cure will not be excluded.
•10. Participants who are not responsive to OCS based on clinical response or
•blood eosinophil counts.
•Prior/Concomitant Therapy:
•11. Participants who have previously received mepolizumab in the 4 months prior
•to enrolment (Visit 2).
•12. Participants receiving any of the following:
•IV or SC corticosteroids in the 4-week period prior to enrolment (Visit 2).
•Any other monoclonal antibodies within 30 days or 5 half-lives, whichever is
•longer, of enrolment (Visit 2).
•Other investigational product/clinical study:
•13. Participants 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 enrolment (Visit 2). The term investigational
•applies to any drug not approved for sale in the country in which it is being
•used or investigational formulations of marketed products
•14. Use of candidate COVID-19 vaccines that have not received limited,
•accelerated, or full authorisation/approval, and are only in use as part of a
•clinical trial
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研究者

发起方

GlaxoSmithKline

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