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RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Eligible participants with mild to moderate asthma will receive a single dose of CDX-622 via IV infusion."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of CDX-622 in adults with mild to moderate asthma. It also looks at how the drug affects the body and how the body processes it. Other study rules may also apply.

This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have had mild to moderate asthma for at least 12 months.
  • Before taking medicine to open your airways, the air you can blow out in 1 second (FEV1) is at least 70% of the expected normal amount.
  • After taking medicine to open your airways, your FEV1 improves by at least 12% and 200 mL.
  • If you could become pregnant or father a child, you agree to use birth control during the study and for 150 days after treatment.
  • You are willing and able to follow all study rules and procedures.

Who can't join

  • You are pregnant or breastfeeding.
  • You have a lung disease other than asthma, or another disease affecting the body that raises eosinophils, a type of white blood cell.
  • You were hospitalized for asthma in the past 12 months, needed steroid pills for asthma in the past 6 months, or have ever needed a breathing machine because of asthma.
  • You have nasal polyps (growths inside the nose), or severe or uncontrolled asthma.
  • You have smoked or vaped in the past 6 months.
  • You have tuberculosis (TB), hepatitis B or C, or HIV.
  • In the past 3 months, you received a biologic drug that changes the immune system, unless it is a long-lasting type.
  • You have ever received drugs that block TSLP or KIT, such as tezepelumab or briquilimab.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 exclusion criteria could apply.

Study sites (4)

CA

KS

MA

PA