A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma
The MODIFY Study: A Phase 3b/4 Randomized, Double-blind, Placebo-controlled, Multi-centre Study Evaluating the Impact of Early Intervention With Depemokimab on Exacerbation Rate, Clinical Remission, Lung Function Decline, and Safety in Adults and Adolescents With at Risk Type 2 Asthma, Conducted up to 156 Weeks
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 12 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well depemokimab works and how safe it is when added to usual asthma care, compared with a placebo. It is for adults and teens with Type 2 asthma, a type linked to inflammation, who are at risk of asthma flare-ups.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 12 or older. Some countries only allow adults age 18 or older.
- Have asthma diagnosed by a doctor for at least 2 years.
- Have at least 2 asthma flare-ups in the past 3 years, including at least 1 in the past year. These must have needed steroid treatment for at least 3 days despite regular asthma inhalers.
- Have needed a low- or medium-dose steroid inhaler plus a long-acting medicine that opens the airways during the past year. Treatment must be stable for 3 months before screening.
- Have high eosinophils, a type of white blood cell: at least 500 cells per microliter at screening or in the past 3 months.
- Or, have eosinophils of at least 300 cells per microliter in that time, plus either a breath test showing nitric oxide of at least 35 parts per billion or ongoing sinus swelling with nasal polyps (growths inside the nose).
- If able to become pregnant, use highly effective birth control from at least 14 days before the first dose until at least 35 weeks after the last dose. Required pregnancy tests must be negative.
- Be able to sign the study consent or agreement form and follow study requirements.
Who can't join
- Have had asthma for more than 20 years, 3 or more flare-ups in the past year, or a flare-up within 4 weeks before screening. A flare-up just before treatment assignment may delay that visit.
- Use daily oral steroids or high-dose combination asthma inhalers, or have trouble taking asthma control medicines as directed or following the doctor's advice.
- Have another serious lung disease, a condition that raises eosinophils, blood vessel inflammation, or a weakened immune system not caused by asthma steroid treatment.
- Have an unresolved parasite infection from the past 6 months, current cancer, cancer in remission for less than 12 months, or another serious health condition not controlled by treatment.
- Have serious abnormal blood, urine, liver, or heart tests, liver scarring, or unstable liver or bile duct disease.
- Have ever received a monoclonal antibody treatment (a type of biologic medicine), or have an allergy or intolerance to these medicines or depemokimab ingredients.
- Currently smoke or vape, or previously smoked at least 20 pack-years—for example, 1 pack a day for 20 years. Alcohol or drug misuse within the past 2 years also excludes people.
- Be pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 (\<)1%, from at least 14 days prior to the first dose of study intervention until at least 35 weeks after the last administered dose of study intervention. * A POCBP must have a negative highly sensitive serum pregnancy test at Screening Visit 1, Exit Visit 11 or Withdrawn from study visit, and a negative highly sensitive urine pregnancy test within 24 hours before the first dose of study intervention. * Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention). * 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/assent as which includes compliance with the requirements Randomization inclusion criteria- * Type 2 high disease at risk of asthma exacerbations as defined by either: * An elevated peripheral blood eosinophils (EOS) count of \>=500 cells/microliter (μL) at screening or \>=500 cells/μL in the last 3 months prior to the screening visit. OR * An elevated peripheral blood EOS count of \>=300 cells/μL at screening OR \>=300 cells/μL 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 (\<=)1.5\*ULN. * Cirrhosis or current unstable liver or biliary disease as per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice. Cardiac safety exclusion criteria: * Electrocardiogram (ECG) Assessment: QTc corrected by Fridericia's formula (QTcF) \>=450 millisecond (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. * Participants are excluded if an abnormal ECG finding from central over read of the 12 lead ECG conducted at Screening Visit is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the investigator. Randomization exclusion criteria: * ECG Assessment: QTcF \>=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 \<=1.5\*ULN. * Participants with a clinically significant asthma exacerbation in the 7 days prior to randomization should have their randomization visit delayed until the investigator considers the participant's asthma to be stable. * Maintenance Asthma Therapy: Any changes in the dose or regimen of baseline ICS and/or additional controller medication (except for treatment of an exacerbation) during the run-in period.
Study sites (16)
AR
- GSK Investigational Site · Little Rock, AR 72205US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comKarl Sitz · Principal investigatorMore trials in Little Rock
CA
- GSK Investigational Site · Newport Beach, CA 92663US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comRyan Klein · Principal investigatorMore trials in Newport Beach
CO
- GSK Investigational Site · Aurora, CO 80012US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comTimothy Colander · Principal investigatorMore trials in Aurora
FL
- GSK Investigational Site · Aventura, FL 33180US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comJaime Landman · Principal investigatorMore trials in Aventura
- GSK Investigational Site · Kissimmee, FL 34746US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comFred Umeh · Principal investigatorMore trials in Kissimmee
- GSK Investigational Site · Lake Worth, FL 33460US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comRafael Nunez-Avila · Principal investigatorMore trials in Lake Worth
- GSK Investigational Site · Miami, FL 33135US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comMark Kutner · Principal investigatorMore trials in Miami
- GSK Investigational Site · Miami, FL 33144US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comYamirka Sanchez · Principal investigatorMore trials in Miami
- GSK Investigational Site · Miami, FL 33173US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comIleana Rodicio · Principal investigatorMore trials in Miami
LA
- GSK Investigational Site · Shreveport, LA 71105US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comDavid Green · Principal investigatorMore trials in Shreveport
OK
- GSK Investigational Site · Oklahoma City, OK 73112US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comCarl Griffin · Principal investigatorMore trials in Oklahoma City
PA
- GSK Investigational Site · DuBois, PA 15801US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comSandeep Bansal · Principal investigatorMore trials in DuBois
- GSK Investigational Site · Wyomissing, PA 19610US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comAlec Platt · Principal investigatorMore trials in Wyomissing
SD
- GSK Investigational Site · Rapid City, SD 57702US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comRichard Beasley · Principal investigatorMore trials in Rapid City
TX
- GSK Investigational Site · San Antonio, TX 78229US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comRobert Jacobs · Principal investigatorMore trials in San Antonio
VA
- GSK Investigational Site · Burke, VA 22015US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comNashwa Gabra · Principal investigatorMore trials in Burke