Mild to Moderate Asthma
Conditions
Keywords
Asthma, Mild to moderate, CDX-622
Brief summary
This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.
Detailed description
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).
Interventions
DRUGCDX-622
Administered Intravenously
Sponsors
Celldex Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability profile of CDX-622 in adults with mild to moderate asthma. | Day 1 up to Day 85 (12 weeks) | Occurrence and incidence of Treatment-Emergent Adverse Events (TEAE) and serious adverse events during the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in fractional exhaled nitric oxide (FeNO) through week 12. | Day 1 up to Day 85 (12 weeks) | Pre-treatment and post-treatment FeNO levels will be measured at specified visits and analyzed to evaluate changes from baseline in airway inflammation. |
| Change from baseline in absolute eosinophil count (AEC) through week 12. | Day 1 up to Day 85 (12 weeks) | Pre-treatment and post treatment blood samples will be collected at specified visits and analyzed for changes in AEC. |
| Change from baseline through week 12 in serum biomarkers. | Day 1 up to Day 85 (12 weeks) | Pre-treatment and post-treatment blood samples will be collected at specified visits and analyzed for changes in TSLP- and SCF-related serum biomarkers. |
| Pharmacokinetic (PK) evaluation from baseline through week 12. | Day 1 up to Day 85 (12 weeks) | CDX-622 serum concentrations measured at specific visits. |
Countries
United States
Contacts
CONTACTCelldex Therapeutics
Outcome results
None listed