Efficacy and Safety of Depemokimab for Early Intervention in Adults and Adolescents with Type 2 Asthma at Risk of Exacerbations

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What is this study about?

Adults and adolescents who have Type 2 asthma that continues to cause frequent exacerbations despite taking regular inhaled corticosteroids together with a long-acting beta agonist are the focus of this study. The investigational medicine is a subcutaneous injection called depemokimab given at a dose of 100 mg every 26 weeks, and it is compared with a matching placebo that looks the same but does not contain the active drug.

The purpose of the trial is to find out whether early use of depemokimab can lower the number of worsening episodes and keep asthma under better control. Participants will be randomly assigned to receive either the study drug or the placebo, with injections administered in a clinic setting every six months. Over a period that may extend up to three years, they will attend regular visits where doctors will check symptoms, record any serious attacks, and perform simple breathing tests.

During the study, several easy‑to‑understand tools are used: the ACT questionnaire asks about daily symptoms, the AQLQ asks how asthma affects quality of life, and the ACQ-5 measures recent symptom severity. Lung capacity is measured with a test called FEV1, which shows how well the lungs move air in and out, providing an overview of overall lung function. Safety checks are also performed at each visit to monitor how participants tolerate the treatment.

1 enrollment and consent

after you agree to participate, you sign a consent form that explains the study and your rights.

the study team confirms that you meet the required criteria for adults or adolescents with type 2 asthma.

2 baseline assessments

you undergo a series of tests to record your current health status.

these include a lung function test called post‑bronchodilator forced expiratory volume in one second (post‑BD FEV1), a questionnaire called the asthma control test (ACT), and other standard asthma questionnaires.

your usual asthma medicines, such as inhaled corticosteroids (ICS) and long‑acting beta‑agonists (LABA), are noted.

3 randomization

the study assigns you, by chance, to receive either the active drug depemokimab or a matching placebo.

you do not know which one you will receive, and the study staff also remain unaware.

4 first injection

on the same day as randomization you receive a single subcutaneous injection (under the skin).

the injection contains either depemokimab 100 mg or a saline placebo solution.

the injection is given in a pre‑filled syringe and takes only a few minutes.

5 first follow‑up period (weeks 0–26)

you attend scheduled clinic visits to check safety, report any asthma attacks, and repeat the ACT questionnaire.

lung function may be measured again at selected visits.

your regular asthma medicines continue unchanged unless your doctor advises otherwise.

6 second injection

at week 26 you receive a second subcutaneous injection of the same product you received at the first injection (either depemokimab 100 mg or placebo).

the procedure is identical to the first injection.

7 second follow‑up period (weeks 27–52)

clinic visits continue as before to monitor safety, record any asthma exacerbations, and complete the ACT questionnaire.

lung function tests are repeated at predetermined times.

8 third injection

at week 52 you receive the third subcutaneous injection of the assigned product.

9 third follow‑up period (weeks 53–78)

you keep attending regular visits for safety checks, asthma symptom reporting, and questionnaire completion.

10 fourth injection

at week 78 you receive the fourth subcutaneous injection of the assigned product.

11 fourth follow‑up period (weeks 79–104)

the pattern of clinic visits, safety monitoring, and questionnaires continues.

12 fifth injection

at week 104 you receive the fifth subcutaneous injection of the assigned product.

this visit also includes a comprehensive assessment to determine whether you have achieved clinical remission (no asthma attacks, no need for maintenance oral corticosteroids, ACT score of 20 or higher, and no decline in lung function).

13 fifth follow‑up period (weeks 105–130)

you continue regular monitoring visits as described previously.

14 sixth injection

at week 130 you receive the sixth subcutaneous injection of the assigned product.

15 final follow‑up period (weeks 131–156)

clinic visits persist for safety evaluation and final data collection.

the last study visit occurs at week 156 (approximately three years after the first injection) and includes the final lung function test, ACT questionnaire, and overall assessment of any asthma exacerbations during the entire study.

16 study completion

after the week‑156 visit the study ends for you.

your doctor will discuss any further treatment options based on the results of the study and your personal health needs.

Who Can Join the Study?

Age: You must be at least 12 years old. In some countries only adults (18 years or older) are allowed to join.
Asthma diagnosis: You need a doctor‑confirmed diagnosis of asthma that has been present for at least 2 years and follows recognized asthma guidelines.
Exacerbation history: You must have had at least two asthma attacks (worsening of symptoms) in the past 3 years, and at least one of those attacks must have occurred in the year before screening. An attack is counted if it required treatment with systemic corticosteroids (steroid medication given by mouth, injection, or IV) for at least three days, even though you were already using inhaled medicines.
Current asthma treatment: You must be taking a combination of low‑to‑medium dose inhaled corticosteroid (ICS) and a long‑acting bronchodilator (LABA) for at least the last three months. The study will limit the number of participants on the lowest dose to 40 %.
Sex and birth‑control requirements: Both men and women can join. Women must not be pregnant or breastfeeding and must use a highly effective birth‑control method (failure rate < 1 %) if they could become pregnant. A negative pregnancy test is required before the first dose.
Informed consent: You must be able to read, understand, and sign a consent form agreeing to follow the study rules.
T2 asthma criteria: At the end of the initial run‑in period you must show signs of “type‑2” (T2) inflammation, such as:
- A blood eosinophil count (a type of white blood cell) of 500 cells/µL or higher, or 300 cells/µL or higher together with a FeNO level (a breath test for airway inflammation) of 35 parts per billion or more.
- Or, you have chronic sinus disease with nasal polyps (CRSwNP).
These tests indicate the kind of inflammation the study is targeting.

Who Cannot Join the Study?

Had three or more asthma attacks (also called exacerbations) in the year before the first study visit.
Have serious heart, hormone, immune, metabolism, nerve, mental health, kidney, stomach, liver, blood, or other organ problems that are not well controlled with usual treatment.
Have a current diagnosis of vasculitis (inflammation of blood vessels). If doctors suspect vasculitis during screening, it must be ruled out before joining.
Have received any approved or experimental biologic monoclonal antibody (mAb) treatment.
Have a history of alcohol misuse or drug misuse within the past two years.
Are current smokers or former smokers with a smoking history of 20 or more pack‑years (cigarettes per day ÷ 20 × years smoked), or use vaping devices. A former smoker is someone who quit at least six months ago.
Are allergic or intolerant to a monoclonal antibody, biologic drug, or any ingredient (called excipients) in depemokimab.
Are pregnant, planning to become pregnant, or breastfeeding.
Have shown a lack of adherence to asthma controller medicines or cannot follow the doctor’s recommendations.
Have abnormal blood, chemistry, or urine test results that the doctor judges as clinically significant.
Have an ALT level (a liver enzyme) more than twice the upper limit of normal.
Are on maintenance oral corticosteroids (OCS) or high‑dose inhaled corticosteroid/long‑acting beta‑agonist (ICS/LABA) therapy for asthma.
Have a total bilirubin level (a liver waste product) more than 1.5 times the upper limit of normal, unless they have Gilbert’s syndrome with a direct bilirubin ≤ 1.5 × ULN.
Have cirrhosis or an unstable liver or bile‑duct disease (signs such as fluid buildup, confusion, clotting problems, low albumin, varices, or ongoing jaundice).
Have an ECG (heart rhythm test) showing a QTcF interval ≥ 450 ms (or ≥ 480 ms if they have a bundle‑branch block), or any other abnormal ECG judged important by the doctor.
Have had asthma for more than 20 years.
Have another significant lung disease besides asthma (e.g., current infection, bronchiectasis, lung scarring, fungal infection, lung cancer, emphysema, chronic bronchitis/COPD).
Have conditions that can raise eosinophils (a type of white blood cell), such as hypereosinophilic syndromes, Eosinophilic Granulomatosis with Polyangiitis (formerly Churg‑Strauss syndrome), or eosinophilic esophagitis.
Had an asthma attack within four weeks before screening (they can reschedule after the attack resolves and four weeks have passed).
Have a known parasitic infection within six months before screening unless it has been treated and resolved.
Have a known immune deficiency (e.g., HIV) that is not caused by steroid use for asthma.
Have a current cancer or a cancer that was treated less than twelve months ago (skin cancers that were completely removed are allowed).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
MediTrial s.r.o.	Jindřichův Hradec	Czechia
Fakultni Nemocnice Brno	Brno	Czechia
Centre hospitalier universitaire de Liege	Liege	Belgium
Medif	Thuin	Belgium
Pneumocare	Namur	Belgium
MUDr. Ilona Pavlisova s.r.o.	Miroslav	Czechia
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari	Bari	Italy
Connolly Hospital	Dublin	Ireland
Beaumont Hospital	Dublin	Ireland
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Berufsausuebungsgemeinschaft Bag Prof Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR	Leipzig	Germany
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Del Mar	Barcelona	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Klifeck GmbH	Delitzsch	Germany
Hospital Universitario Virgen De Las Nieves	Granada	Spain
POIS Sachsen GmbH	Leipzig	Germany
Our Lady Of Lourdes Hospital	Drogheda	Ireland
IKF Pneumologie GmbH & Co. KG	Frankfurt	Germany
Regional Hospital Mullingar	Mullingar	Ireland
MECS Research GmbH	Berlin	Germany
Pneumologisches Studienzentrum MVZ die Lungenärzte	Berlin	Germany
Studienzentrum Dr Keller 4OG	Frankfurt	Germany
Fundacion Para La Investigacion Biomédica Del Hospital Universitario 12 De Octubre	Madrid	Spain
Czfnhcjvu Usgcbhrssunjhr Smvsgbjjr	Woluwe-Saint-Lambert	Belgium
Uygfchqvxr Oc Aezaeng	Edegem	Belgium
Eenjcpt	Mechelen	Belgium
Uueaotcqyn Daemw Srwor Di Rlgt Lo Sbztadbz	Rome	Italy
Uuforkfezo Mqwbe Godxiap Ot Cseftiwvz	Catanzaro	Italy
Pfuwhx Rqgvlceqvqx Hvypiy Syul	Barcelona	Spain
Kplu Gkca	Bendorf	Germany
Hxwwexyp Uugfyeljberpf Mnmvaho Dx Vkyuzfpajb	Santander	Spain
Cmzn Udsdgjsncz Hwihwwfs	Cork	Ireland
Hvvafgib Uxznrjpiavgua Hnflghls Tbruj y Ppwkrt Iwfjlxhp Cghjyw dypzcezrjlemyzfmf (jpbx	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	08.05.2026
Czechia	Not yet recruiting	08.05.2026
Germany	Not yet recruiting	08.05.2026
Ireland	Not yet recruiting	08.05.2026
Italy	Not yet recruiting	08.05.2026
Spain	Not yet recruiting	08.05.2026

Trial locations

Investigated Drugs:

Depemokimab

depemokimab is a new injectable medicine being tested to help people with type 2 asthma who still have attacks even though they are already using inhaled steroids and long‑acting bronchodilators. In the study, participants receive the medicine under the skin every six months. Researchers are looking to see if it can lower the number of asthma attacks, improve lung function, and keep patients in remission for a longer time while also checking that it is safe to use.

Asthma – Asthma is a chronic condition that causes the airways in the lungs to become inflamed and narrowed. This narrowing makes breathing difficult and can lead to symptoms such as wheezing, coughing, and shortness of breath. The inflammation can increase over time, especially when exposed to triggers like allergens, exercise, or cold air. As the disease progresses, episodes of worsening symptoms, called exacerbations, may occur more frequently. These episodes can happen even when standard inhaled medicines are used, reflecting a change in the level of airway inflammation. The condition often varies day to day, with periods of better control alternating with periods of increased symptoms.

Trial ID:

2025-524463-20-00

Protocol code:

222926

NCT ID:

NCT07456033

Trial Phase:

Therapeutic confirmatory (Phase III)

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Efficacy and Safety of Depemokimab for Early Intervention in Adults and Adolescents with Type 2 Asthma at Risk of Exacerbations

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?