Rademikibart for COPD

Recruiting at 20 trial locations

Overseen By Radha Adivikolanu

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Connect Biopharm LLC

Must be taking: Systemic corticosteroids

Must not be taking: Immunosuppressives, Macrolides

Disqualifiers: Asthma, Heart disease, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Rademikibart to determine its effectiveness for people with COPD experiencing flare-ups and inflammation. The trial aims to assess whether Rademikibart improves symptoms compared to a placebo (a non-active treatment). Suitable participants have had COPD for at least a year, have experienced flare-ups requiring steroid treatment, and are either current or former smokers. They should currently be experiencing a flare-up that requires medical attention. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on regular immunosuppressive medication or long-term macrolides. You also cannot have received certain drugs or treatments within specific time frames before joining the trial.

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

Research has shown that Rademikibart has been tested for safety in people with COPD, a lung disease that makes breathing difficult. The most common side effects included cough, COVID-19 infection, and shortness of breath, affecting about 10% to 12% of patients.

While these side effects are not unusual for people with COPD, awareness of their potential occurrence is important. This treatment is currently under evaluation for its effectiveness and safety in people with COPD experiencing a sudden worsening of symptoms. As the study is in Phase 2, researchers continue to gather information to ensure its safety for wider use. ^{1 2 3 4 5}

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

Rademikibart is unique because it offers a new approach to treating COPD by targeting specific pathways involved in the disease’s progression. Unlike the standard treatments like bronchodilators and corticosteroids, which primarily work by opening airways and reducing inflammation, Rademikibart focuses on modulating the underlying biological processes of COPD, potentially providing a more comprehensive treatment. Researchers are excited about Rademikibart because it might offer improved efficacy and fewer side effects compared to existing therapies, bringing new hope for patients suffering from this chronic respiratory condition.

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

Research has shown that Rademikibart, which participants in this trial may receive, may improve lung function in individuals with conditions like COPD (chronic obstructive pulmonary disease). In earlier studies, people with asthma experienced significant lung improvements within a week, with benefits lasting up to 24 weeks. This suggests that Rademikibart might offer similar benefits for those with COPD, especially during sudden flare-ups. A closer examination of past studies indicates that people with COPD could see the most improvement when using Rademikibart. This treatment might provide quick and lasting relief for those dealing with COPD symptoms. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with COPD who've had at least one flare-up in the last year needing steroids. They must have been diagnosed over a year ago, smoked at least 10 pack-years, and be having a flare-up now that needs urgent care and steroids. Their blood must show certain levels of eosinophils (a type of white blood cell).

Inclusion Criteria

My blood test showed eosinophils ≥250 cells/μL in the last year.

My blood test shows high eosinophil levels during my recent COPD flare-up.

I have been diagnosed with COPD for at least a year.

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 COPD exacerbation

4 weeks

Weekly visits (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 tests Rademikibart, given through prefilled syringes, against a placebo to see if it helps during severe COPD attacks linked to type 2 inflammation. It's done across multiple centers where patients are randomly assigned to either treatment.

How Is the Trial Designed?

Group I: Rademikibart Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Connect Biopharm LLC

Lead Sponsor

Trials

9

Recruited

1,500+

Citations

1. atsjournals.org atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A1313

Efficacy of Rademikibart in COPD-like Patients In a previously reported Phase 2b asthma trial, rademikibart demonstrated significant improvements in lung function by Week 1 that were sustained through 24- ...

2. investors.connectbiopharma.com investors.connectbiopharma.com/news-releases/news-release-details/connect-biopharma-initiates-phase-2-seabreeze-stat-copd-study

Connect Biopharma Initiates Phase 2 Seabreeze STAT COPD ... Data from the post-hoc analysis highlights the potential of rademikibart to improve outcomes for patients with COPD, with greatest improvements ...

3. medcentral.com medcentral.com/immunology/asthma/asthma-drug-works-faster-than-expected-and-may-treat-copd-as-well

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.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06940154?lastUpdPost=2020-01-10_

Rademikibart Add-on Treatment of an Acute COPD ... This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute COPD exacerbation with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12091008/

Rademikibart Treatment for Moderate-to-Severe Uncontrolled ... In summary, 24 weeks of rademikibart at 150 mg and 300 mg Q2W resulted in rapid and sustained improvements in lung function in patients with moderate-to-severe ...

6. investors.connectbiopharma.com investors.connectbiopharma.com/news-releases/news-release-details/connect-biopharma-announces-publication-positive-data-global

Press Release - Investors | Connect Biopharma Holdings Ltd Rademikibart demonstrated rapid onset of action with significant improvements in lung function observed at one week and maintained through 24 weeks –.

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/600036

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

8. firstwordpharma.com firstwordpharma.com/story/5963517

Connect Biopharma Presents Data Supporting ... Findings support rademikibart's potential as an effective therapy for patients with asthma or COPD experiencing an acute exacerbation, providing ...