Not recruiting

Study of Rocatinlimab compared to Placebo to help adults with Moderate to Severe Asthma

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with moderate-to-severe asthma, a condition where airways become inflamed and narrow, making breathing difficult. The research examines a new medication called rocatinlimab, which is given as an injection under the skin. The purpose is to determine how effective this medication is in reducing asthma attacks or worsening of symptoms.

During the study, participants will receive either rocatinlimab at different dose levels or placebo through subcutaneous (under the skin) injections. The study will monitor how well the medication works in preventing asthma attacks, which can include symptoms severe enough to require steroid treatment, emergency room visits, or hospital stays.

Throughout the treatment period, participants will need to continue using their regular asthma medications, including their usual inhaled corticosteroids and other controller medications. The study will track various aspects of participants' asthma symptoms and their response to the treatment, including how often they experience asthma attacks and any changes in their daily symptoms.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial Treatment Phase
You will be assigned to receive either rocatinlimab (study medication) or placebo (inactive substance) through subcutaneous injection (injection under the skin)
You will continue your current asthma medications including your inhaled corticosteroids (ICS) and other controller medications at stable doses
This is a double-blind study, which means neither you nor the study staff will know which treatment you are receiving
Step 2
Monitoring Period
Your asthma symptoms will be tracked using an Asthma Symptom Diary
Blood samples will be collected at specific times to measure the levels of rocatinlimab in your body
The study team will monitor for any worsening of your asthma symptoms
Step 3
Asthma Exacerbation Assessment
Any severe worsening of your asthma symptoms will be recorded as an exacerbation if it requires:
Use of oral steroids for 3 or more days
An emergency department visit requiring steroids for 3 or more days
Hospitalization due to asthma
Step 4
Study Duration
The study is planned to run from November 2024 to October 2026
Your participation duration will be specified in your individual study schedule

Who can join the trial?

10 criteria

Must be aged between 18 and 75 years old or meet the legal age requirement in your country when signing the consent form
Must have asthma diagnosed by a physician for at least 12 months before screening
Must be currently using medium to high-dose inhaled corticosteroids (ICS) such as fluticasone propionate (a type of inhaler medication that helps control asthma symptoms)
check
Must be using at least one additional asthma control medication for at least 90 days before screening, such as:
- Long-acting beta agonists (medications that help open airways)
- Leukotriene receptor antagonists (pills that help control inflammation)
- Long-acting muscarinic antagonists (medications that help relax airway muscles)
- Methylxanthines (medications that help relax airways)
- Oral corticosteroids (up to 10 mg prednisone or equivalent daily)
- Must have been on a stable dose of these medications for at least 30 days before screening
- Both men and women can participate

Who cannot join the trial?

15 criteria

Age below 18 years or above 75 years
Pregnant or breastfeeding women
History of severe allergic reactions to biological medications
Current participation in other clinical trials
Presence of any active infections (including tuberculosis)
Uncontrolled cardiovascular disease (problems with heart or blood vessels)
Significant kidney or liver disease
History of cancer within the past 5 years
Use of other biological therapies (specialized medications that target specific parts of the immune system) within the past 3 months
Poorly controlled diabetes
History of chronic respiratory diseases other than asthma
Current smoking or history of smoking within the past year
Known immunodeficiency conditions (weakened immune system)
Mental health conditions that could interfere with study participation
Inability to perform breathing tests accurately

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
CRU Hungary Kft.
Encs, Hungary
Verified
Diagnostics And Consultation Center Convex Ltd.
Sofia, Bulgaria
Verified
Spitalul Clinic De Boli Infectioase Si Pneumoftiziologie Victor Babes Craiova
Craiova, Romania

Trial locations

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Investigated drugs

Rocatinlimab is an investigational medication being studied for treating moderate to severe asthma. It is a type of biologic therapy that works by targeting specific components of the immune system involved in asthma symptoms. The medication aims to help reduce asthma attacks (exacerbations) in adult patients who have difficulty controlling their asthma with standard treatments.

Rocatinlimab

What is already known about the treatment

Rocatinlimab - A novel investigational monoclonal antibody administered through subcutaneous injection, currently being studied in Phase 2 clinical trials for the treatment of moderate-to-severe asthma. This biological medication works by targeting specific immune system pathways involved in the inflammatory response associated with asthma, aiming to reduce the frequency and severity of asthma exacerbations. As a targeted immunotherapy agent, rocatinlimab represents a potential new treatment option for patients whose asthma is not adequately controlled with conventional therapies, though its complete safety and efficacy profile is still being established through ongoing clinical research.

Investigated diseases

Asthma (Moderate-to-severe) - A chronic respiratory condition where airways become inflamed, narrow, and produce extra mucus, making breathing difficult. In moderate-to-severe cases, patients experience more frequent and intense symptoms, including wheezing, coughing, and shortness of breath. The airways are particularly sensitive to various triggers such as allergens, air pollution, or physical activity, leading to episodes of increased symptoms called exacerbations. During these episodes, the airways become more constricted, causing increased difficulty in breathing. The condition typically fluctuates with periods of better and worse symptoms, and patients may experience nighttime or early morning worsening.