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Recruiting NCT07456033

A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma

Conditions: Asthma

Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 456
Sponsor: GlaxoSmithKline

Location: GSK Investigational Site Newport Beach California

Summary

The aim of this study is to evaluate the efficacy of depemokimab administered as an adjunctive therapy, in participants with Type 2 asthma at risk of exacerbations compared to the guideline recommended standard of care (SoC).

Eligibility Criteria

Inclusion Criteria: * Adults and adolescents \>=12 years of age, at the time of signing the informed consent/assent. For countries where local regulations or the regulatory status of study medication permit enrolment of adults only, participants recruited will be \>=18 years of age. * Participants must have a documented physician diagnosis of asthma for \>=2 years that meets the National Heart, Lung, and Blood Institute, National Institute for Health and Care Excellence or Global Initiative for Asthma guidelines * Have previously confirmed history of at least 2 exacerbations over the last 3 years prior to screening, with at least 1 of those exacerbations occurring in the previous year prior to Screening Visit 1. * Exacerbation requiring treatment with systemic Corticosteroid (CS), for at least 3 days, despite the use of low to medium dose Inhaled corticosteroids (ICS)/ Long-acting beta2-adrenergic receptor agonist (LABA). * A well-documented requirement for treatment with low to medium dose ICS/LABA (in the 12 months prior to screening visit. Treatment should be stable for 3 months prior to screening. If participants are taking Maintenance and Reliever Therapy/Single Maintenance and Reliever Therapy regularly, the total daily dose should be incorporated into the assessment of low or medium dose ICS. * Study will limit enrolment to a maximum of 40 percent (%) of participants on low dose ICS/LABA. * Sex and Contraceptive/Barrier Requirements Male or eligible female Participants: * Male Participants: Contraception for male participants with female partners is not required. * Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: * Is a participant of nonchildbearing potential (PONCBP) OR * Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\=500 cells/milliliter (mL) at screening or \>=500 cells/mL in the last 3 months prior to the screening visit. OR * An elevated peripheral blood EOS count of \>=300 cells/mL at screening OR \>=300 cells/mL in the last 3 months prior to the screening visit AND * Fractional exhaled nitric oxide \>=35 parts per billion (ppb) at screening. OR * Documented current Chronic Rhinosinusitis with Nasal Polyps. Exclusion Criteria: * Participants have had 3 or more exacerbations in the last year prior to Visit 1. * Participants on maintenance OCS or high dose ICS/LABA for asthma. * Participants with a duration of asthma greater than (\>)20 years. * Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic Obstructive Pulmonary Disease other than asthma) are excluded. * Participants with other conditions that could lead to elevated EOS such as hypereosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome) or eosinophilic esophagitis. * Participants who developed an exacerbation within 4 weeks before screening. * Participants with a known, pre-existing parasitic infestation within 6 months prior to screening unless treated and evidenced to have been resolved. * A known immunodeficiency (e.g. human immunodeficiency virus), other than that explained by the use of CS taken as therapy for asthma. * A current malignancy or previous history of cancer in remission for less than 12 months prior to screening. * Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic, hematologic or any other system abnormalities that are uncontrolled with standard treatment. * Participants with current diagnosis of vasculitis. * Participants who have received treatment with any approved or investigational biologic monoclonal antibody (mAb). * A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to the first dose of study intervention. * Current smokers or former smokers with a smoking history of \>=20 pack years (number of pack years = \[number of cigarettes per day/20\] \* number of years smoked) and vapers. * Participants with allergy/intolerance to a mAb or biologic or any of the excipients of depemokimab. * Participants who are pregnant or breastfeeding. * Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations. * Evidence of clinically significant abnormality in the hematological, biochemical or urinalysis screen at screening (Visit 0), as judged by the investigator. Liver safety exclusion criteria: * Alanine aminotransferase (ALT) \>2\* Upper limit of normal (ULN). * Total bilirubin \>1.5\*ULN; For participants with Gilbert's syndrome: can be included with total bilirubin \>1.5\*ULN as long as direct bilirubin is less than or equal to (\=450 msec or QTcF \>=480 msec for participants with Bundle Branch Block in the 12-lead ECG central over-read from Screening Visit, or in the 12 lead ECG machine read at Visit 1. * ALT \>2\*ULN. * Total bilirubin \>1.5\*ULN; For participants with Gilbert's syndrome can be included with total bilirubin \>1.5\*ULN as long as direct bilirubin is \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07456033). StuddyBuddy aggregates publicly available trial information.