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New treatment option for Asthma
Official title Depemokimab Asthma Imaging and Bronchoscopy Sub-Study
ClinicalTrials.gov ID: NCT06979323
What this study is testing
What is Depemokimab?
Depemokimab is an investigational medicine, being studied as a potential treatment for asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Asthma is a chronic condition marked by narrowed and swollen airways due to inflammation leading to recurring symptoms that can vary and worsen unpredictably.\\xa0The purpose of this study is to assess how depemokimab, a monoclonal antibody, affects the structure and function of the lungs in asthmatic participants with type 2 inflammation, characterized by an eosinophilic phenotype.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented clinical diagnosis of asthma for greater than or equal to (\>=) 2 years as per the National Heart, Lung, and Blood Institute guidelines...
- Uncontrolled asthma indicated by Astha Control Questionnaire-5 (ACQ-5) greater than (\>) 1.5 recorded at screening
- Persistent airflow obstruction as indicated by pre-bronchodilator Forced Expiration Volume in 1 second (FEV1) less than (\<) 80 percentage (%)...
- A well-documented requirement for regular treatment with medium or high dose ICS (in the 12 months prior to screening with or without maintenance...
- Current treatment with at least one additional asthma controller medication, besides ICS, for at least 3 months [for example, Long-acting Beta 2...
You likely can't join if
- Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection...
- Participants with other conditions that could lead to elevated eosinophils such as hyper eosinophilic syndromes including (but not limited to)...
- 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 HIV), other than that explained by the use of corticosteroids (CSs) taken as therapy for...
- A current malignancy or previous history of cancer in remission for less than 12 months prior to screening
See the full eligibility criteria
Who can join
- Documented clinical diagnosis of asthma for greater than or equal to (\>=) 2 years as per the National Heart, Lung, and Blood Institute guidelines (NHLBI, 2020) or GINA guidelines (GINA, 2024), or joint guidance from...
- Uncontrolled asthma indicated by Astha Control Questionnaire-5 (ACQ-5) greater than (\>) 1.5 recorded at screening
- Persistent airflow obstruction as indicated by pre-bronchodilator Forced Expiration Volume in 1 second (FEV1) less than (\<) 80 percentage (%) predicted (GLI 2012) and recorded at screening
- A well-documented requirement for regular treatment with medium or high dose ICS (in the 12 months prior to screening with or without maintenance oral corticosteroids [OCS])
- Current treatment with at least one additional asthma controller medication, besides ICS, for at least 3 months [for example, Long-acting Beta 2 agonists [LABA], Long-acting muscarinic antagonists [LAMA], leukotriene...
- Male Participants: No additional requirements for male 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 non-childbearing potential (PONCBP) or is a participant of...
- A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention
- Capable of giving written informed consent,
- For the bronchoscopy sub study participants who sign the Informed Consent for the biopsy sub study, the following additional eligibility criteria will apply:
- Participants not on maintenance OCS (oral corticosteroids) at the time of screening.
- Participants with post bronchodilator FEV1 \>= 50% predicted
- Participants with no known increased risk for bleeding or clotting abnormalities including: No history of easy bleeding, bruising or known bleeding diathesis; No current anticoagulant and antiplatelet therapy; No...
- Participants with no specific contraindication to bronchoscopy with endobronchial biopsy in the opinion of the investigator
- No history of allergic reaction to local anesthesia or general anesthetic agent, whichever is relevant to the procedure being performed
What rules you out
- 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...
- Participants with other conditions that could lead to elevated eosinophils such as hyper eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as...
- 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 HIV), other than that explained by the use of corticosteroids (CSs) 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 abnormalities or any other system...
- Participants with current diagnosis of vasculitis
- Participants who have a previous documented failure with anti-IL-5/5R therapy
- Participants who have received monoclonal antibody (mAb) therapy targeting IL 5/5R, IL 4R/IL 13, IL 33, IgE, or Thymic Stromal Lymphpoietin (TSLP) within 12 months or 5 terminal phase half-lives of the drug, whichever...
- Participants who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to the first dose of study intervention (this also...
- Previously participated in any clinical study with biologic treatments for asthma (for example, omalizumab, mepolizumab, dupilumab, reslizumab, benralizumab, other mAbs (including Tezepelumab) or depemokimab and...
- 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 \>=20 pack years (number of pack years = [number of cigarettes per day/20] x 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
- Participants who have occupational ionizing-radiation exposure exceeding 10 Millisievert (mSV) over 3 years as documented with a dosimeter; have been exposed to elevated ionizing radiation from research imaging studies...
- Presence of metal objects that may interfere with chest CT quantification including presence of a cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile or metal weapon fragment (bullet...
- Evidence of clinically significant abnormality in the hematological, biochemical or urinalysis screen at screening (Visit 0), as judged by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Brooksville, Florida, United States
- Plantation, Florida, United States
- Kansas City, Kansas, United States
- St Louis, Missouri, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- DuBois, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- McKinney, Texas, United States
- Mechelen, Belgium
- Namur, Belgium
- Ajax, Ontario, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Guangzhou, China
- Shanghai, China
- Tianjin, China
- Brest, France
- Créteil, France
- La Tronche, France
+ 25 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brooksville, Florida, United States; Plantation, Florida, United States; Kansas City, Kansas, United States; St Louis, Missouri, United States; New Brunswick, New Jersey, United States; New York, New York, United States and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.