AzTrials
AzTrials

AsthmaPhase 4PRISMNCT04276233

Efficacy and Safety Study of Mepolizumab 100 Milligram (mg) Subcutaneous (SC) in Indian Participants Aged Greater Than or Equal to (>=) 18 Years With Severe Eosinophilic Asthma

A Phase 4 study testing Mepolizumab and Salbutamol in people with Asthma, run by GlaxoSmithKline at 14 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Mepolizumab is a humanized monoclonal antibody (IgG1, kappa) that blocks interleukin- 5 (IL-5) thus inhibits production and survival of eosinophils. The aim of this phase 4, open-label, single-arm study is to evaluate the safety and efficacy of Mepolizumab 100 mg SC administered every 4 weeks in Indian participants… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma
What is being tested?
Mepolizumab and Salbutamol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
14 sitesIndia
Study dates
29 Jun 2021to 28 Oct 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be greater than or equal to (≥) 18 to 65 years of age inclusive, at the time of signing the informed consent.
  • Asthma: Evidence of asthma as documented by either: (a) Airway reversibility (FEV1>=12% and 200 milliliter (ml) demonstrated at Visit 1 (screening) or Visit 2 (Week 0) OR documented in the previous 12 months OR (b) Airway hyperresponsiveness (methacholine: PC20 of <8mg/mL or histamine: PD20 of <7.8 μmol; mannitol: decrease in FEV1 as per the labelled product instructions) documented in the 12 months prior to Visit 2 (Week 0) OR (c) Airflow variability in clinic FEV1 >=20% between two consecutive clinic visits documented in the 12 months prior to Visit 2 (FEV1 recorded during an exacerbation should not be considered for this criteria) OR (d) Airflow variability as indicated by >20% diurnal variability in peak flow observed on 3 or more days during the optimization period.
  • Participants with Eosinophilic asthma: prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma as FEV1: Persistent airflow obstruction as indicated by: For participants >=18 years of age at Visit 1 (screening) or Visit 2 (Week 0), a pre- bronchodilator FEV1 <80% predicted. For predicted FEV1 values National Health and Nutrition Examination Survey (NHANES) III values will be used and adjustments to these values will be made for race.
  • Eosinophilic Phenotype: Airway inflammation characterized as eosinophilic in nature as indicated by one of the following characteristics: (a) An elevated peripheral blood eosinophil level of >=300 cells/microliter(μL) that is related to asthma within the previous 12 months prior to Visit 2 (Week 0). OR (b) Peripheral baseline eosinophil level >=150 cells/μL between Visit 1 (screening) and Visit 2 (Week 0) that is related to asthma.
  • Participants eligible for mepolizumab treatment as per independent clinical judgment of treating physician in alignment with local prescribing information.
  • Inhaled Corticosteroids: requirement for regular treatment with high dose inhaled corticosteroid in the 6 months prior to Visit 1 (screening). For 18 years of age and older: Inhaled corticosteroids (ICS) dose must be >=880 microgram (mcg)/day fluticasone propionate (FP) (ex-actuator) or equivalent daily.
Show all 12Show fewer
  • Controller Medication: Current treatment with an additional controller medication for at least 3 months OR having used and failed an additional controller medication for at least 3 successive months during the prior 12 months [e.g., long-acting beta2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline].
  • Male or eligible female. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: (a) Is not a woman of childbearing potential (WOCBP) OR (b) Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1% during the intervention period and for at least 16 weeks after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. (c) A WOCBP must have a negative highly sensitive pregnancy test (serum) within 8 weeks before the first dose of study intervention. (d) Additional requirements for pregnancy testing during and after study intervention are located. (e) The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • 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.
  • Treatment Period Criteria
  • Eosinophilic asthma: Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma.
  • eDiary Compliance: Compliance with completion of the eDiary defined as: (a) Completion of symptom scores on 4 or more days out of the last 7 days immediately preceding Visit 2 (Week 0). (b) Completion of information relating to rescue medication use on 4 or more days out of the last 7 days immediately preceding Visit 2 (Week 0). (c) Completion of PEF measurements on 4 or more days out of the last 7 days immediately preceding Visit 2 (Week 0).

Who cannot join

  • Concurrent Respiratory Disease: Presence of a clinically important lung condition other than asthma. This includes but is not limited to current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
  • Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior screening (Participants who had localized carcinoma (i.e. basal or squamous cell) of the skin which was resected for cure will not be excluded).
  • Liver Disease: Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, and known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Cardiovascular: Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment. Including but not limited to: (a) known ejection fraction of <30% OR (b) severe heart failure meeting New York Heart Association Class IV OR (c) hospitalized in the 12 months prior to Visit 1 (screening) for severe heart failure meeting New York Heart Association Class III OR (d) angina diagnosed less than 3 months prior to Visit 1 (screening) or at Visit 1.
  • Other Concurrent Medical Conditions: Participants who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
  • Eosinophilic Diseases: Participants with other conditions that could lead to elevated eosinophils such as Hypereosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophaghitis. Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1 (screening) are also to be excluded.
Show all 22Show fewer
  • Omalizumab Use: Participants who have received omalizumab within 130 days of Visit 1 (screening).
  • Other Monoclonal Antibodies: Participants who have received any monoclonal antibody (other than omalizumab) to treat inflammatory disease within 5 half-lives of Visit 1 (screening).
  • Investigational Medications: Participants who have received treatment with an investigational drug within the past 30 days or five terminal phase half-lives of the drug whichever is longer, prior to Visit 1 (this also includes investigational formulations of marketed products).
  • Participants who have previously participated in any study of mepolizumab and received Investigational Product (including placebo).
  • ECG: ECG assessment QTcF > 450msec or QTcF > 480 msec for participants with Bundle Branch Block. Participants are excluded if an abnormal ECG finding from the 12-lead ECG conducted at Screening (Visit 1) is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the Investigator.
  • Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus - HIV), other than that explained by the use of corticosteroids taken as therapy for asthma.
  • Smoking history: Current smokers or former smokers with a smoking history of >=10 pack years. A former smoker is defined as a participant who quit smoking at least 6 months prior to Visit 1 (screening).
  • Hypersensitivity: Participants with a known allergy or intolerance to a monoclonal antibody or biologic.
  • Pregnancy: Participants who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the time of study participation.
  • Alcohol/Substance Abuse: A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1 (screening).
  • Adherence: Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations.
  • Treatment Period Criteria
  • Laboratory abnormality: Evidence of clinically significant abnormality in the haematological, biochemical or urinalysis screen at Visit 1 (screening), as judged by the investigator.
  • Alanine transferase (ALT) >2 x upper limit of normal (ULN).
  • Bilirubin > 1.5 x ULN (isolated bilirubin>1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • No cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice. Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C e.g., presence of hepatitis B surface antigen [HBsAg] or positive hepatitis C antibody test result) is acceptable if the participant otherwise meets eligibility criteria.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

India14 sites

  • GSK Investigational Site

    Ahmedabad, 380013

  • GSK Investigational Site

    Ahmedabad, 380052

  • GSK Investigational Site

    Byculla Mumbai, 400008

  • GSK Investigational Site

    Hyderabad, 500018

  • GSK Investigational Site

    Hyderabad, 500038

  • GSK Investigational Site

    Hyderabad, 500082

  • GSK Investigational Site

    Jaipur, 302039

  • GSK Investigational Site

    Kanpur, 208005

  • GSK Investigational Site

    Kolkata, 700014

  • GSK Investigational Site

    Nagpur, 440012

  • GSK Investigational Site

    New Delhi, 110096

  • GSK Investigational Site

    Noida, 201301

  • GSK Investigational Site

    Pune, 411001

  • GSK Investigational Site

    Pune, 411004

Other trials in India

About this study

Official title: A Phase 4, Open-label, Single Arm, 24-week, Study to Evaluate the Safety and Efficacy of Mepolizumab 100 mg SC Administered Every 4 Weeks in Indian Participants Aged ≥18 Years With Severe Eosinophilic asthMa (PRISM)

Mepolizumab is a humanized monoclonal antibody (IgG1, kappa) that blocks interleukin- 5 (IL-5) thus inhibits production and survival of eosinophils. The aim of this phase 4, open-label, single-arm study is to evaluate the safety and efficacy of Mepolizumab 100 mg SC administered every 4 weeks in Indian participants aged 18 years or above with severe eosinophilic asthma. After the first dose of mepolizumab, participants will receive 5 more doses of mepolizumab at 4 weekly intervals. Following the last dose of mepolizumab, the end of the study Visit will occur 4 weeks later. During the treatment period, OCS use and dose adjustment in participants will be as per the investigator's discretion and clinical practice.

Conditions
Asthma
Being tested
Mepolizumab, Salbutamol
Keywords
Mepolizumab, Oral corticosteroids, Prednisolone, Prednisone, Severe Eosinophilic asthma
Medical subject headings
Asthma, Pulmonary Eosinophilia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MepolizumabDrug

    Mepolizumab will be available as a lyophilized cake in sterile vials and will be reconstituted with sterile water for injection, just prior to use.

  • SalbutamolDrug

    Salbutamol metered dose inhalers (MDIs) will be provided as rescue medication during treatment period.

Study groups in NCT04276233
Study groupRoleWhat they receive
Participants with severe eosinophilic asthmaExperimentalParticipants with severe eosinophilic asthma will receive Mepolizumab 100 mg subcutaneously into the upper arm or thigh every 4 weeks for a period of 24 weeks (total of 6 doses). Salbutamol metered dose inhalers (MDIs) will be provided as rescue medication during treatment period.
Receives: Drug: Mepolizumab; Drug: Salbutamol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Any untoward medical occurrence that, at any dose that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Adverse events which were not serious were considered as non-serious adverse events. Number of participants with SAEs and common (greater than equal to [>=] 3 percent [%]) non-SAEs were reported.

    Measured: Up to Week 24

  2. Number of Participants With Adverse Events of Special Interest (AESIs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were adverse events associated with the identified and potential risks of mepolizumab. AESIs were systemic/ local site reactions, all infections (Infections from Infections and infestations System Organ Class [SOC]), opportunistic infections, neoplasm, malignancies, cardiac disorders and serious cardiac, vascular and thromboembolic (CVT) events.

    Measured: Up to Week 24

Secondary outcomes (7)

  1. Number of Participants With Clinically Significant Exacerbations (Including Exacerbations Requiring Hospitalization or Emergency Department [ED Visits])

    Clinically significant exacerbations of asthma were defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or ED visits. Exacerbations were treated per the investigator's clinical practice protocol with the use of oral or parenteral corticosteroids. Clinically significant exacerbations were recorded in the electronic case report form (eCRF) by the Investigator or designee were verified using data from the electronic Diary. Number of participants with clinically significant exacerbations were reported.

    Measured: Up to Week 24

  2. Number of Participants With Exacerbations Requiring Hospitalization or ED Visits

    Exacerbations of asthma are defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or ED visits. Number of participants with exacerbations requiring hospitalization or ED visits were reported.

    Measured: Up to Week 24

  3. Number of Participants With Exacerbations Requiring Hospitalization

    Exacerbations of asthma are defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization. Number of participants with exacerbations requiring hospitalization were reported.

    Measured: Up to Week 24

  4. Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24

    FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. The change from Baseline in pre-bronchodilator FEV1 was calculated as the value at Week 24 minus the value at Baseline.

    Measured: Baseline (Weeks -2 to -1) and Week 24

  5. Change From Baseline in Clinic Post-bronchodilator FEV1 at Week 24

    FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. The change from Baseline in post-bronchodilator FEV1 was calculated as the value at Week 24 minus the value at Baseline.

    Measured: Baseline (Weeks -2 to -1) and Week 24

  6. Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24

    The ACQ-5 is a five-item questionnaire, designed to be self-completed by the participants. The five questions (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms. The response options for all these questions consists of a zero (no impairment/limitation) to six (total impairment/ limitation). The ACQ-5 score is calculated as the mean of these 5 item responses and ranges from scores 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. The change from Baseline was calculated as the value at Week 24 minus the Baseline value.

    Measured: Baseline (Weeks -2 to -1) and Week 24

  7. Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 21 to 24

    PEF was defined as the maximum speed of expiration of a participant, measured with electronic peak flow meter. Baseline is defined as the value recorded at pre-dose (Weeks -2 to -1) assessment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Measured: Baseline (Weeks -2 to -1) and Weeks 21 to 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2020
  2. Study start29 Jun 2021
  3. Primary completion28 Oct 2023
  4. Study completion28 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm study
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04276233
Sponsor's protocol ID
209682
Acronym
PRISM
Status last verified
Oct 2024
First submitted
17 Feb 2020
Last updated
10 Dec 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mepolizumab and Salbutamol in people with Asthma, run by GlaxoSmithKline at 14 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) (time frame: Up to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04276233.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in