RecruitingPhase 3

Depemokimab Asthma Imaging and Bronchoscopy Sub-Study

The IMAGINE Study: A Phase 3b Open Label, Single Arm Study to Assess the Effect of Depemokimab on Airway Structure and Function in Asthma With Type 2 Inflammation Characterized by an Eosinophilic Phenotype Utilizing Quantitative High-resolution CT and Bronchoscopic Airway Sampling in a Sub Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 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 depemokimab affects lung structure and how well the lungs work. It is for people with asthma and high levels of eosinophils, a type of white blood cell linked to swelling in the airways.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a documented asthma diagnosis for at least 2 years, with blood eosinophils of at least 300 cells per microliter at screening or in the past 3 months.
  • Have a breath nitric oxide level of at least 25 parts per billion at screening. This test measures airway swelling.
  • Have had at least 2 asthma flare-ups needing steroid pills or shots in the past year, despite using medium- or high-dose inhaled steroids.
  • Have poorly controlled asthma, with an asthma questionnaire score above 1.5. Before airway-opening medicine, a breathing test must show less than 80% of the expected result.
  • Have needed regular medium- or high-dose inhaled steroids for the past year. Also have used at least one other asthma control medicine for at least 3 months.
  • If able to become pregnant, use highly effective birth control that needs little user action and have a negative pregnancy test within 24 hours before the first dose. You must not be pregnant or breastfeeding.
  • Be able to give written consent to join.
  • For the airway tissue sample group: do not take daily oral steroids; have a breathing test result of at least 50% after airway-opening medicine; and have no added bleeding risk, blood-thinning medicines, or aspirin use within 2 weeks. You must have normal platelets, no allergy to the needed numbing or anesthesia drugs, and no medical reason to avoid the airway scope and tissue sample.

Who can't join

  • Have another important lung disease, another illness that raises eosinophils, blood vessel inflammation, or an asthma flare-up within 4 weeks before screening.
  • Have an unresolved parasite infection from the past 6 months, a weakened immune system not caused by asthma steroids, current cancer, or cancer in remission for less than 12 months.
  • Have a serious health condition not controlled by usual treatment, or important abnormal blood or urine test results.
  • Have previously failed anti-IL-5/5R treatment, which targets eosinophils, or recently received certain antibody treatments. The waiting period is at least 12 months and may be longer. Authorized COVID-19 treatments are allowed.
  • Have recently taken an experimental drug, or received treatment or placebo in an asthma biologic drug study within the past 12 months. Experimental drugs require a wait of at least 30 days, and sometimes longer.
  • Currently smoke or vape, or formerly smoked at least 20 pack-years, such as 1 pack daily for 20 years. Alcohol or drug misuse within the past 2 years also excludes you.
  • Are pregnant or breastfeeding; have an allergy or cannot tolerate biologic drugs or depemokimab ingredients; or have known problems taking asthma control medicines or following medical advice.
  • Have certain radiation exposure at work or from research scans in the past 3 years, or metal objects that could affect chest CT images, such as a pacemaker, metal heart valve, or metal shoulder joint.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 the British Thoracic Society, National Institute for Health and Care Excellence, and Scottish Intercollegiate Guidelines Network \[NICE, 2024\] along with the following: an eosinophilic phenotype as evidenced by a blood eosinophil count of \>=300 cells/microliters (mcL) at screening or a documented history of blood eosinophil count \>=300 cells/mcL within 3 months prior to screening; Exhaled nitric oxide (FeNO) measure of \>=25 parts per billion (ppb) recorded at screening; and a previously confirmed history of \>= 2 exacerbations requiring treatment with systemic corticosteroid (SCS; intramuscular \[IM\], intravenous \[IV\], or oral), in the 12 months prior to screening, despite the use of medium to high dose Inhaled corticosteroids (ICS) * 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 receptor antagonist (LTRA), or theophylline\] * 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 childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency, * 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 acetylsalicylic acid use within 2 weeks of the planned procedure; Normal screening platelet count * 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 Exclusion Criteria: * 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 \[COPD\] other than asthma) are excluded * 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 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 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 abnormalities that are uncontrolled with standard treatment * 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 is longer prior to the screening. Authorized treatments for Coronavirus disease-2019 (COVID-19) are permitted * 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 includes investigational formulations of marketed products) * 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 received study intervention (including placebo) within 12 months prior to the first dose of study intervention * 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, for example, Participation in a research study with a single positron emission tomography scan in the past 3 years, and Participation in a research study with 2 or more computed tomography (CT) scans in the past 3 years in the following anatomical regions: chest, abdomen, cardiac, or spine * 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, shrapnel, shotgun shot) or metal shoulder prosthesis * Evidence of clinically significant abnormality in the hematological, biochemical or urinalysis screen at screening (Visit 0), as judged by the investigator

Study sites (9)

FL

KS

MO

NJ

NY

PA

TX