A Study of CDX-622 in Participants With Mild to Moderate Asthma
ConditionMild to Moderate Asthma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCelldex Therapeutics
About this trial
This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females, ≥ 18 years of age
Diagnosis of mild to moderate asthma for at least 12 months
Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted normal
Airway reversibility ≥ 12% and 200 mL improvement in FEV1
Disqualifiers
Females who are pregnant or nursing
Pulmonary disease other than asthma
Systemic diseases with elevated eosinophils other than asthma
Hospitalization for treatment of asthma in the past 12 months or required oral corticosteroids due to asthma within the past 6 months
Trial design
Design model
Single group
Treatments tested in this trial
CDX-622
DrugAdministered Intravenously
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: CDX-622Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the safety and tolerability profile of CDX-622 in adults with mild to moderate asthma.
Occurrence and incidence of Treatment-Emergent Adverse Events (TEAE) and serious adverse events during the study.
Time frame
Day 1 up to Day 85 (12 weeks)Secondary outcomes
1
Change from baseline in fractional exhaled nitric oxide (FeNO) through week 12.
Pre-treatment and post-treatment FeNO levels will be measured at specified visits and analyzed to evaluate changes from baseline in airway inflammation.
Time frame
Day 1 up to Day 85 (12 weeks)2
Change from baseline in absolute eosinophil count (AEC) through week 12.
Pre-treatment and post treatment blood samples will be collected at specified visits and analyzed for changes in AEC.
Time frame
Day 1 up to Day 85 (12 weeks)3
Change from baseline through week 12 in serum biomarkers.
Pre-treatment and post-treatment blood samples will be collected at specified visits and analyzed for changes in TSLP- and SCF-related serum biomarkers.
Time frame
Day 1 up to Day 85 (12 weeks)4
Pharmacokinetic (PK) evaluation from baseline through week 12.
CDX-622 serum concentrations measured at specific visits.
Time frame
Day 1 up to Day 85 (12 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov