A Study of CDX-622 in Participants With Mild to Moderate Asthma
Recruiting · NCT07330778 · Interventional (participants receive a specific treatment) · Lead sponsor: Celldex Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
CDX-622
What this trial is about
This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- Key
Exclusion criteria
- 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
- History of needing ventilator support due to asthma
- Current nasal polyps
- Severe or uncontrolled asthma
- History of smoking or vaping within the past 6 months
- Tuberculosis, hepatitis B or C virus, or HIV
- 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.
Where it is running
4 locations listed across 4 US states.
- University of California, San Francisco - San Francisco, California, United States
- The University of Kansas Medical Center - Kansas City, Kansas, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- University of Pittsburgh Asthma and Environmental Lung Health Institute at UPMC - Pittsburgh, Pennsylvania, United States