Rademikibart for COPD

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

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+