Health TrialsbyHealthPanel

Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)

ConditionCOPD Acute Exacerbation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorConnect Biopharm LLC

About 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 does not accept healthy volunteers

Qualifiers

Physician-diagnosed COPD with duration of ≥12 months.

Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.

Participants in a stable condition must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.

Current or former smoker with a history of smoking of ≥10 pack-years.

Disqualifiers

Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer.

Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome.

Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results.

Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rademikibart in prefilled syringe

    Combination product

    Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.

  • Matching placebo in prefilled syringe

    Drug

    Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: RademikibartExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment failure rate

Treatment failure is defined as death due to any cause, (re)admission to a hospital for COPD, ED (re)visit or unscheduled medical visit for worsening of COPD symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for COPD exacerbation) within 28 days after randomization.

Time frame
28 days

Secondary outcomes

1

Absolute change from baseline (CFB) in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 1

Time frame
Week 1
2

Rate of new moderate and severe COPD exacerbations over the 28 days after randomization

Time frame
28 days
3

Time to the first new moderate or severe COPD exacerbation in the 28 days after randomization

Time frame
28 days
4

Mean CFB in EXACT-PRO score

Mean CFB in clinical respiratory symptoms of COPD using the E-RS: COPD (Evaluating Respiratory Symptoms in COPD) comprised in the EXACT-PRO through Week 1, Week 2, and Week 4. The Exacerbations of Chronic Pulmonary Disease Tool - Patient-Reported Outcome (EXACT-PRO) is a PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in patients with COPD.

Time frame
Week 1, Week 2, and Week 4

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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