Health TrialsbyHealthPanel

Rademikibart IV for Acute Asthma and COPD Exacerbation

ConditionsAsthma AcuteCOPD Exacerbation Acute
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorConnect Biopharm LLC

About this trial

A Phase 2, open-label, single-arm trial to evaluate IV rademikibart as an add-on treatment for acute exacerbation in participants with asthma or COPD with type 2 inflammation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Asthma cohort

Body weight of ≥40 kg and BMI ≤45 kg/m2 at SV1a.

Physician-diagnosed asthma

Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication.

Disqualifiers

Asthma cohort

Regular use of immunosuppressive medication.

Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.

Current or former smoker, with a smoking history of ≥5 pack-years if <30 years old or ≥10 pack-years if ≥30 years old

Trial design

Design model

Single group

Treatments tested in this trial

  • Rademikibart

    Drug

    Single 300 mg dose as a 2-minute IV push

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: RademikibartExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in post-BD FEV1

Time frame
1 week

Secondary outcomes

1

Change from baseline in post-BD FEV1 at scheduled timepoints

Time frame
Days 1, 2, 3, 14, 28, and 42
2

Incidence of treatment-emergent adverse events

Time frame
42 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Connect Biopharm LLC

Lead sponsor

Source ClinicalTrials.gov
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