Rademikibart for Asthma

Overseen By Radha Adivikolanu

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Connect Biopharm LLC

Must be taking: ICS, Asthma controllers

Must not be taking: Immunosuppressives, Type 2 cytokine modulators

Disqualifiers: Heart disease, Smoking history, COPD, 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, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation

Eligibility Criteria

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.

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 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

Treatment Details

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.

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+