Last updated: 05/22/2025 03:50:23
NUCALA Post Marketing Surveillance Study in India
GSK study ID
217046
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: An observational, 24 week, open-label, multi-center, prospective post marketing surveillance study to evaluate the safety, tolerability and patient treatment experience (PTE) of mepolizumab administration via autoinjector for adult patients aged 18 years or older suffering with severe eosinophilic asthma
Trial description: This study will evaluate the safety, tolerability, effectiveness and PTE of mepolizumab administration by patients or caregivers at home (self-administration) or healthcare providers (HCPs) in clinic, via a ready-to-use prefilled autoinjector in Indian patients with severe eosinophilic asthma
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants experiencing an adverse events (AE), serious adverse events (SAE) and adverse events of special interest (AESI)
Timeframe: Up to 24 weeks
Secondary outcomes:
Frequency and incidence of clinically significant asthma exacerbations with mepolizumab treatment
Timeframe: Pre-exposure to 24 weeks post exposure
Frequency and incidence of clinically significant asthma exacerbations requiring Emergency Department (ED) visits and/or hospitalization
Timeframe: Pre-exposure to 24 weeks post exposure
Interventions:
Not applicable
Enrollment:
150
Primary completion date:
2023-15-05
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
November 2022 to May 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Patient must be ≥18 years of age inclusive, at the time of signing the informed consent (at Visit 1)
- Patients suffering from severe refractory eosinophilic asthma* who have an indication from prescribing physician to start or have already started an add-on treatment of mepolizumab by subcutaneous (SC) administration by patients or caregivers at home or healthcare providers in-clinic using a ready-to-use prefilled autoinjector.
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study except if, in the opinion of the investigator, the expected benefit outweighs the potential risk to the fetus.
- Contraindications: Any contraindications as per prescribing information or conditions that, in the opinion of the Investigator, contraindicates study participation.
Inclusion and exclusion criteria
Inclusion criteria:
- Patient must be ≥18 years of age inclusive, at the time of signing the informed consent (at Visit 1)
- Patients suffering from severe refractory eosinophilic asthma* who have an indication from prescribing physician to start or have already started an add-on treatment of mepolizumab by subcutaneous (SC) administration by patients or caregivers at home or healthcare providers in-clinic using a ready-to-use prefilled autoinjector. * Severe Eosinophilic Asthma Diagnosis: An established clinical history of severe eosinophilic asthma in accordance with the physician’s clinical decision and confirmed by clinical documents, reports and notes (a peripheral blood eosinophil count of more than 150/ microliter (μL) at initiation of treatment or >300/ μL in previous 12 months that is related to asthma, is essential for inclusion, before the first mepolizumab injection for treatment naïve patients only).
- Not receiving any prior mepolizumab treatment at Visit 1 (treatment-naïve) OR
- Received one dose of 100 milligram (mg) SC mepolizumab administered for the treatment of severe eosinophilic asthma every 4 weeks prior to Visit 1.(liquid formulation of mepolizumab)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, in accordance with applicable laws.
Mepolizumab treatment:
Exclusion criteria:
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study except if, in the opinion of the investigator, the expected benefit outweighs the potential risk to the fetus.
- Contraindications: Any contraindications as per prescribing information or conditions that, in the opinion of the Investigator, contraindicates study participation.
- Patients with other conditions that could lead to elevated eosinophils such as Hyper eosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis. Patients with a known, pre-existing parasitic infestation within 6 months prior to Visit 1 should be treated appropriately before inclusion in the study.
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
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website