A Phase 1 interventional study of CDX-622 in Mild to Moderate Asthma, sponsored by Celldex Therapeutics. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Celldex Therapeutics · Phase 1, Interventional, and Treatment
This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.
CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP). Eligible participants with mild to moderate asthma will receive a single dose of CDX-622 via IV infusion. Additional follow-up visits will be required through EOS (week 12).
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 12 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Celldex Therapeutics is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 1 (7%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Additional protocol defined inclusion and exclusion criteria could apply.
Eligible participants will receive a single dose
Drug: CDX-622
Administered Intravenously
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)
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)
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)
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)
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)
Plan to share: Undecided
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Celldex Therapeutics