A Study of CDX-622 in Participants With Mild to Moderate Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CDX-622.
- Who it may be relevant to
- Registry conditions: Mild to Moderate Asthma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label, Single-Dose Study to Assess the Safety, Pharmacodynamics, and Pharmacokinetics of CDX-622 in Adults With Mild to Moderate Asthma
Overview
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
- Drug CDX-622
Administered Intravenously
Primary outcome measures
- To evaluate the safety and tolerability profile of CDX-622 in adults with mild to moderate asthma. [Time frame: Day 1 up to Day 85 (12 weeks)]
Secondary outcome measures (4)
- Change from baseline in fractional exhaled nitric oxide (FeNO) through week 12. [Time frame: Day 1 up to Day 85 (12 weeks)]
- Change from baseline in absolute eosinophil count (AEC) through week 12. [Time frame: Day 1 up to Day 85 (12 weeks)]
- Change from baseline through week 12 in serum biomarkers. [Time frame: Day 1 up to Day 85 (12 weeks)]
- Pharmacokinetic (PK) evaluation from baseline through week 12. [Time frame: Day 1 up to Day 85 (12 weeks)]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- University of California, San Francisco — San Francisco
- The University of Kansas Medical Center — Kansas City
- Brigham and Women's Hospital — Boston
- University of Pittsburgh Asthma and Environmental Lung Health Institute at UPMC — Pittsburgh
Identifiers
NCT: NCT07330778 · CDX622-02