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
1 other identifier
interventional
12
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2025
CompletedFirst Posted
Study publicly available on registry
January 9, 2026
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 1, 2026
March 1, 2026
1.1 years
September 26, 2025
March 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (4)
Change from baseline in fractional exhaled nitric oxide (FeNO) through week 12.
Day 1 up to Day 85 (12 weeks)
Change from baseline in absolute eosinophil count (AEC) through week 12.
Day 1 up to Day 85 (12 weeks)
Change from baseline through week 12 in serum biomarkers.
Day 1 up to Day 85 (12 weeks)
Pharmacokinetic (PK) evaluation from baseline through week 12.
Day 1 up to Day 85 (12 weeks)
Study Arms (1)
CDX-622
EXPERIMENTALEligible participants will receive a single dose
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Females who are pregnant or nursing
- Pulmonary disease other than asthma
- Systemic diseases with elevated eosinophils other than asthma
- Hospitalization or 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 12 months
- Tuberculosis, hepatitis B or C virus, or HIV
- Immunomodulating biologic therapies within the past 3 months
- Prior receipt of TSLP or KIT inhibitors such as tezepelumab or briquilimab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2025
First Posted
January 9, 2026
Study Start
February 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
April 1, 2026
Record last verified: 2026-03