160 Participants Needed

Rademikibart for Asthma

Recruiting at 23 trial locations
RA
Overseen ByRadha Adivikolanu
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Connect Biopharm LLC
Must be taking: ICS, Asthma controllers
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Rademikibart for individuals with asthma who have type 2 inflammation, a specific immune response. The goal is to determine if Rademikibart can manage asthma symptoms more effectively than a placebo (a substance with no active drug). Participants must have had asthma for at least a year and currently use inhalers or other medications for asthma control. They should also have experienced at least one severe asthma attack requiring steroid treatment. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it does require that you are already on certain asthma treatments. You should discuss your specific medications with the trial team to see if any changes are needed.

Is there any evidence suggesting that Rademikibart is likely to be safe for humans?

Research has shown that rademikibart may improve lung function and control asthma. One study found that patients experienced quick and lasting benefits over 24 weeks. Importantly, research indicates that rademikibart does not increase eosinophils (a type of white blood cell) in the blood, which can be a concern with some asthma treatments.

Although detailed safety information from earlier phases is not available, this is a Phase 2 trial, meaning rademikibart has already passed initial safety tests. These trials primarily focus on the treatment's effectiveness and continue to monitor safety. While some safety data exist, more will be collected during this phase.12345

Why do researchers think this study treatment might be promising for asthma?

Rademikibart is unique because it targets a novel pathway in asthma management, potentially offering relief where traditional treatments like inhaled corticosteroids and bronchodilators fall short. Unlike these standard options, which primarily focus on reducing inflammation or relaxing airway muscles, Rademikibart may work by modulating specific immune responses that trigger asthma attacks. Researchers are excited about the possibility of Rademikibart providing more personalized and effective treatment options for patients who don't respond well to existing therapies.

What evidence suggests that Rademikibart might be an effective treatment for asthma?

Research has shown that Rademikibart, which participants in this trial may receive, greatly improves lung function and helps control asthma. Patients experienced quick and lasting improvements over 24 weeks of treatment. Studies found that both doses of Rademikibart improved lung function by Week 12. The treatment works quickly and may also be useful for other lung conditions like COPD, a long-term lung disease. Overall, evidence suggests Rademikibart could be effective for people with asthma and type 2 inflammation.12367

Are You a Good Fit for This Trial?

This trial is for adults and adolescents with asthma who've been on a steady asthma control regimen for at least 60 days, have had an exacerbation in the past year requiring steroids, and show certain levels of blood eosinophils. They must be currently experiencing an acute asthma attack needing urgent care.

Inclusion Criteria

I have been diagnosed with asthma for at least 12 months.
I have had an eosinophil count of 250 or more in the last year.
My blood test shows I have high eosinophils due to a severe asthma attack.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rademikibart or placebo as an add-on to standard therapy for acute asthma exacerbation

4 weeks
Visits as needed for acute care

Follow-up

Participants are monitored for treatment failure, including hospital readmission or need for additional treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Rademikibart
Trial Overview The study tests Rademikibart, a new medication given by injection, against a placebo (a treatment with no active drug). Participants are randomly assigned to one of these treatments to see if Rademikibart can improve outcomes during an acute asthma flare-up.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RademikibartExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Connect Biopharm LLC

Lead Sponsor

Trials
9
Recruited
1,500+

Citations

Connect Biopharma Presents Data Supporting Rademikibart ...Rademikibart demonstrated rapid and significant improvement in lung function and asthma control in patients, with greatest improvements ...
Rademikibart Treatment for Moderate-to-Severe ...Conclusions: Rapid and sustained improvements in lung function and asthma control were gained across 24 weeks of rademikibart therapy. Clinical ...
Rademikibart Treatment for Moderate-to-Severe Uncontrolled ...Rapid and sustained improvements in lung function and asthma control were gained across 24 weeks of rademikibart therapy.
Methodology Results Conclusions ObjectiveBoth rademikibart doses achieved the primary endpoint, improvement in lung function at Week 12, as well as large and significant improvement in asthma ...
Asthma Drug Works Faster Than Expected – and May Treat ...Rademikibart trial data point to rapid improvement in asthma, with potential for similar benefit in COPD. An ATS 2025 meeting highlight.
NCT06940141 | Rademikibart Add-on Treatment of an ...For participants in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb. Current acute ...
Study Highlights Impact of Rademikibart on Blood ...A new analysis suggests that, unlike dupilumab, rademikibart does not cause eosinophil elevation in patients with asthma.
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