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