A Study of CDX-622 in Participants With Mild to Moderate Asthma

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.

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).

Key Inclusion Criteria:

1. Males and females, ≥ 18 years of age
2. Diagnosis of mild to moderate asthma for at least 12 months
3. Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted normal
4. Airway reversibility ≥ 12% and 200 mL improvement in FEV1
5. Both males and females of child-bearing potential must agree to use contraception during the study and for 150 days after treatment
6. Willing and able to comply with all study requirements and procedures

Key Exclusion Criteria:

1. Females who are pregnant or nursing
2. Pulmonary disease other than asthma
3. Systemic diseases with elevated eosinophils other than asthma
4. Hospitalization for treatment of asthma in the past 12 months or required oral corticosteroids due to asthma within the past 6 months
5. History of needing ventilator support due to asthma
6. Current nasal polyps
7. Severe or uncontrolled asthma
8. History of smoking or vaping within the past 6 months
9. Tuberculosis, hepatitis B or C virus, or HIV
10. Immunomodulating biologic therapies within the past 3 months for non-extended half-life biologics.
11. Prior receipt of TSLP or KIT inhibitors such as tezepelumab or briquilimab

Additional protocol defined inclusion and exclusion criteria could apply.