40 Participants NeededMy employer runs this trial

Rademikibart for Asthma and COPD Exacerbation

Recruiting at 1 trial location
RA
Overseen ByRadha Adivikolanu
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Connect Biopharm LLC
Must be taking: Corticosteroids, Asthma controllers
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 tests an experimental treatment called rademikibart to determine its effectiveness for people with asthma or COPD during sudden symptom worsening. It targets patients with type 2 inflammation, a specific immune response. The trial seeks individuals who have recently experienced a flare-up requiring urgent care and steroid medication. Participants must have a doctor-diagnosed condition and a history of exacerbations. Those managing asthma or COPD with medications and recent urgent health visits for flare-ups may find this trial suitable. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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

Research has shown that rademikibart is generally safe. In earlier studies involving people with asthma, those taking rademikibart experienced fewer asthma flare-ups compared to those on a placebo (a pill with no active medicine). Specifically, participants on rademikibart had about 0.24 to 0.30 flare-ups per year, while the placebo group had 0.56 flare-ups. This suggests that rademikibart may help reduce asthma symptoms without causing many additional problems.

The most common side effects reported were cough, COVID-19 infection, and shortness of breath. These side effects seem manageable and are somewhat expected given the breathing issues being treated. Overall, rademikibart appears well-tolerated, and its safety profile supports its use in further trials.12345

Why do researchers think this study treatment might be promising?

Rademikibart is unique because it targets the underlying inflammation in asthma and COPD exacerbations differently than current treatments like inhaled corticosteroids, bronchodilators, and leukotriene modifiers. Unlike these options, Rademikibart works by specifically inhibiting a novel inflammatory pathway, which could potentially reduce flare-ups more effectively. Researchers are excited about this treatment because it offers a new mechanism of action that might provide better control of symptoms and improve quality of life for patients.

What evidence suggests that rademikibart might be an effective treatment for asthma and COPD exacerbation?

Research has shown that rademikibart, the investigational treatment in this trial, offers promising results for people with asthma and COPD by improving lung function. One study demonstrated that patients experienced a quick and significant improvement in lung function just 15 minutes after treatment. Other studies have found that these improvements can last up to 24 weeks, with asthma attacks reduced by 63%. Rademikibart targets a part of the immune system related to inflammation, which helps reduce symptoms. The treatment effectively improves lung function quickly, providing relief within 24 hours. These findings suggest that rademikibart could be a helpful additional treatment for managing asthma and COPD flare-ups.23567

Are You a Good Fit for This Trial?

This trial is for people having a sudden worsening of asthma or COPD symptoms, who also have signs of type 2 inflammation. Participants must meet certain health requirements set by the study team.

Inclusion Criteria

My lung function is at least 30% of the expected value for my age and size.
I have had at least one COPD flare-up treated with steroid pills or injections.
I have been diagnosed with COPD by my doctor.
See 14 more

Exclusion Criteria

I have a history of an immune disorder or hepatitis B or C.
I regularly take medication that suppresses my immune system.
I do not have serious or uncontrolled heart conditions.
See 29 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single 300 mg dose of rademikibart administered as a 2-minute IV infusion

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Rademikibart

Trial Overview

The study is testing an intravenous (IV) medication called rademikibart as an extra treatment on top of standard care for those experiencing acute flare-ups of asthma or COPD. All participants receive the same treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: RademikibartExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Connect Biopharm LLC

Lead Sponsor

Trials
9
Recruited
1,500+

Citations

Rademikibart Treatment for Moderate-to-Severe Uncontrolled ...

Rademikibart, at 150 mg and 300 mg every other week, resulted in rapid and sustained improvements in lung function in patients with moderate-to-severe ...

Press Release

Rademikibart demonstrated rapid and significant improvement in lung function and asthma control in patients, a 63% reduction in patients

Rademikibart Add-on Treatment of an Acute COPD ...

Study Overview. Brief Summary. This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation.

Rademikibart Tied to Rapid FEV1 Improvement in Asthma ...

Phase 1 study revealed significant FEV1 improvements within 15 min of a single dose of IV rademikibart -- an antibody targeting IL-4Ra.

Rademikibart for COPD · Info for Participants

In earlier studies, people with asthma experienced significant lung improvements within a week, with benefits lasting up to 24 weeks.

Connect Biopharma Initiates Phase 2 Seabreeze STAT ...

In a prior Phase 2 trial for chronic asthma, rademikibart demonstrated strong efficacy and safety data, with clinically meaningful reductions in ...

Rademikibart Add-on Treatment of an Acute COPD ...

This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation.