CDX-622 given once in adults with mild to moderate asthma
Tests the safety of a single dose of CDX-622 in adults with asthma.
Plain-language title generated from the registry record
Registry title: A Study of CDX-622 in Participants With Mild to Moderate Asthma
Key facts
- Where
- Boston, Kansas City, Pittsburgh, and San Francisco, United StatesSee the 4 sites
- Phase
- Phase 1
Where in United States
- Brigham and Women's HospitalBoston, United StatesTaking people
- The University of Kansas Medical CenterKansas City, United StatesTaking people
- University of Pittsburgh Asthma and Environmental Lung Health Institute at UPMCPittsburgh, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Celldex Therapeutics
- Trial code
- NCT07330778
- Record updated
- 2 July 2026
- Original description
This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.Read full original descriptionShow less
An Open-Label, Single-Dose Study to Assess the Safety, Pharmacodynamics, and Pharmacokinetics of CDX-622 in Adults With Mild to Moderate Asthma
This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.
Inclusion: 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; Both males and females of child-bearing potential must agree to use contraception during the study and for 150 days after treatment; Willing and able to comply with all study requirements and procedures.
Exclusion: Hospitalization for treatment of asthma in the past 12 months or required oral corticosteroids due to asthma within the past 6 months; Immunomodulating biologic therapies within the past 3 months for non-extended half-life biologics; Prior receipt of TSLP or KIT inhibitors such as tezepelumab or briquilimab; Additional protocol defined inclusion and exclusion criteria could apply; Pulmonary disease other than asthma; Systemic diseases with elevated eosinophils other than asthma; History of needing ventilator support due to asthma; History of smoking or vaping within the past 6 months; Tuberculosis, hepatitis B or C virus, or HIV; Females who are pregnant or nursing; Current nasal polyps; Severe or uncontrolled asthma.