Last updated: 04/22/2025 18:40:09

Mepolizumab on Organ Manifestations & Organ damage during Long-Term Disease Progression in Hypereosinophilic Syndrome

GSK study ID
219725
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Descriptive effects of Mepolizumab on Organ Manifestations & Organ dAmage during Long-Term Disease Progression in Hypereosinophilic Syndrom patients – a retrospective data analysis of the CUP (MOMA-LT)
Trial description: This is a multi-centre, retrospective cohort study in 5 Hypereosinophilic Syndrome (HES) centres (‘study centres’) in Germany aiming to collect and analyse long-term treatment data (i.e. treatment with the Interleukin-5 (IL-5) antagonist for greater than or equal to [≥] 2 years) of approximately 31 HES participants who received mepolizumab as part of the Compassionate Use Programme (CUP) for their HES disease. The retrospective observation period for this study is planned for at least 24 months and up to the last follow-up of participants on therapy with mepolizumab from CUP enrolment.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Proportion of Participants who experienced greater than or equal to (>=) 1 flares

Timeframe: From Baseline up to 24 months follow up (FU)

Secondary outcomes:

Proportion of Participants with improvement in clinical Hypereosinophilic Syndrome (HES) signs/symptoms

Timeframe: From Baseline up to 2-year follow up (FU), 3.5-year FU, 5-year FU and > 5 years FU

Annual number of flares per participant

Timeframe: From Baseline up to 2-year follow up (FU), 3.5-year FU, 5-year FU and > 5 years FU

Time to first flare

Timeframe: From Baseline up to 2-year follow up (FU), 3.5-year FU, 5-year FU and > 5 years FU

Duration of flares

Timeframe: From Baseline up to 2-year follow up (FU), 3.5-year FU, 5-year FU and > 5 years FU

Proportion of Participants with eosinophilia

Timeframe: From Baseline up to 2-year follow up (FU), 3.5-year FU, 5-year FU and > 5 years FU

Highest eosinophil Count during follow up

Timeframe: From Baseline up to 2-year follow up (FU), 3.5-year FU, 5-year FU and > 5 years FU

Proportion of Participants with de-escalation or stop of oral corticosteroids (OCS)

Timeframe: From Baseline up to 2-year follow up (FU), 3.5-year FU, 5-year FU and > 5 years FU

Proportion of Participants with de-escalation or stop of cytotoxic or/and immunosuppressive therapy

Timeframe: From Baseline up to 2-year follow up (FU), 3.5-year FU, 5-year FU and > 5 years FU

Proportion of Participants requiring high-dose emergency intravenous (IV) steroid treatment

Timeframe: From Baseline up to 2-year follow up (FU), 3.5-year FU, 5-year FU and > 5 years FU

Proportion of Participants with an improvement in either laboratory, imaging, electrocardiogram (ECG) or biopsy findings

Timeframe: From Baseline up to 2-year follow up (FU), 3.5-year FU, 5-year FU and > 5 years FU

Proportion of Participants with adverse events and serious adverse events (SAEs) related to mepolizumab

Timeframe: From Baseline up to 2-year follow up (FU), 3.5-year FU, 5-year FU and > 5 years FU

Interventions:
Not applicable
Enrollment:
31
Primary completion date:
2025-24-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hypereosinophilic Syndrome
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
April 2024 to March 2025
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • Informed consent is available
  • Participants was enrolled into the GSK HES CUP
  • Exclusion criteria of the GSK HES CUP:
  • Participants without HES but with other conditions associated with eosinophilic pathological processes such as Eosinophilic Granulomatosis with Polyangiitis (EGPA), Wegener’s Granulomatosis, atopic disorders, parasitic infections, eosinophilic gastroenteropathies
Inclusion and exclusion criteria
Inclusion criteria:

    Informed consent is available

    • Participants was enrolled into the GSK HES CUP
    • Treatment with mepolizumab for greater than or equal to (≥) 2 years after enrolment in the HES CUP
    • Inclusion criteria of the GSK HES CUP:
    • In accordance with local procedures, written informed consent/assent could be obtained from the subject or legally authorized representative
    • ≥ 12 years of age at the time of signing the informed consent/assent
    • Meets the diagnostic criteria for HES as defined by:
  • Eosinophilia >1500 cells per microliter (cells/μl) for at least 6 months with evidence of symptoms and signs of organ system involvement or dysfunction that can be directly related to eosinophilia (with no evidence of parasitic, allergic or other recognised causes of eosinophilia such as connective tissues disease, malignancy) or

    • Eosinophilia of >1500 cells/μl for less than 6 months and meet the other criteria for HES accompanied by clear evidence of eosinophil tissue infiltration and with exclusion of secondary causes of eosinophilia as above.

    • Participants meeting all three of the following criteria were eligible:
  • The indication, HES, was a seriously debilitating or life-threatening disease;
  • There was no satisfactory alternative treatment: documented failure (lack of efficacy or a contra-indication) to at least 3 standard therapies (corticosteroids, cytotoxic agents, immunomodulatory therapy, and Imatinib mesylate) at the appropriate duration and dose or demonstrated clinical benefit from prior treatment with mepolizumab; and
  • There was reason to believe that the benefit:risk ratio for mepolizumab in the indication is positive.
Exclusion criteria:

    Exclusion criteria of the GSK HES CUP:

    • Participants without HES but with other conditions associated with eosinophilic pathological processes such as Eosinophilic Granulomatosis with Polyangiitis (EGPA), Wegener’s Granulomatosis, atopic disorders, parasitic infections, eosinophilic gastroenteropathies
    • Female participants of childbearing potential who were not using a highly effective method of contraception
    • Pregnant or lactating females
    • Participants with severe/life-threatening underlying disease unrelated to HES where life expectancy was estimated to be less than 3 months
  • Participants with a history of or current 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 the first dose. Participants that had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure were not be excluded
    • Participants with history of serious allergic reaction (hypersensitivity/anaphylaxis) to anti-IL5 or other antibody therapy or known or suspected hypersensitivity to any component of mepolizumab, leading to treatment discontinuation
    • Participants with current drug or alcohol abuse where uncertain compliance with the protocol and/or with the medical management instruction of the investigator could cause safety risk
    • Participants who had received treatment with an investigational agent (biologic or nonbiologic, excluding mepolizumab) within the past 30 days or 5 drug half-lives whichever is longer, prior to the administration of mepolizumab under the HES CUP protocol. 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.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Study complete
Actual primary completion date
2025-24-03
Actual study completion date
2025-24-03

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website