Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDX-622 | Experimental | Eligible participants will receive a single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDX-622 | Drug | Administered Intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 up to Day 85 (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 up to Day 85 (12 weeks) |
| Change from baseline in absolute eosinophil count (AEC) through week 12. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Additional protocol defined inclusion and exclusion criteria could apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celldex Therapeutics | Contact | 844-723-9363 | clinicaltrials@celldex.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Pre-treatment and post treatment blood samples will be collected at specified visits and analyzed for changes in AEC. |
| 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. | Day 1 up to Day 85 (12 weeks) |
| Pharmacokinetic (PK) evaluation from baseline through week 12. | CDX-622 serum concentrations measured at specific visits. | Day 1 up to Day 85 (12 weeks) |
| The University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| University of Pittsburgh Asthma and Environmental Lung Health Institute at UPMC | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |