RightFit
RecruitingPhase 2

Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids

A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids

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 to 75 Years
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

Not stated in the study description — ask the study team about visits and procedures.

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 how well different doses of tozorakimab work and how safe they are compared with a placebo, a treatment with no active medicine. The medicine is given as a shot under the skin. It is for adults whose asthma is not controlled by medium- or high-dose inhaled steroids.

This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.

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

Eligibility

Who can join

  • Be 18–75 years old and sign a consent form before any study procedures.
  • Have asthma diagnosed by a doctor for at least 12 months.
  • Use a medium- or high-dose inhaled steroid with a long-acting medicine that opens the airways (LABA).
  • Have uncontrolled asthma, with a score of at least 1.5 on the ACQ-6 asthma questionnaire.
  • Before taking medicine to open the airways, have a breathing test result (FEV1) of 40%–90% of the expected normal value.
  • In the past 12 months, have at least 2 severe asthma flare-ups, or 1 severe flare-up plus either a blood eosinophil count of at least 150 cells/µL or a breath nitric oxide level of at least 25 ppb. These tests measure signs of inflammation.
  • Complete at least 70% of the daily asthma diary.
  • If you can become pregnant, have a negative pregnancy test. Men and women must follow local birth control rules for clinical studies.

Who can't join

  • Finished antibiotic treatment for a breathing infection in the 4 weeks before the first visit.
  • Have a significant lung disease other than asthma.
  • Smoke now, or previously smoked more than 10 pack-years—for example, 1 pack a day for more than 10 years.
  • Have significant narrowing of the heart’s aortic valve or high blood pressure in the lung arteries.
  • Have active tuberculosis, hepatitis, HIV, a current cancer diagnosis, or immune complex disease, where clumps of immune proteins can damage tissue.
  • Have an unstable heart or blood vessel condition.

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

Official eligibility criteria

Inclusion Criteria: 1. Provision of signed and dated written informed consent prior to any study-specific procedures. 2. Adults aged 18-75, inclusive when signing the informed consent. 3. Documented physician-diagnosis of asthma for at least 12 months. 4. Treated with medium or high dose ICS in combination with LABA. 5. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 . 6. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal. 7. Documented exacerbation history in the last 12 months and biomarker requirements of: 1. ≥ 2 severe exacerbations OR 2. 1 severe exacerbation and: (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb 8. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary. 9. Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test. 10. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: 1. Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1. 2. Clinically significant pulmonary disease other than asthma . 3. Current smokers, former smokers with \>10 pack-years history. 4. Clinically significant aortic stenosis or pulmonary arterial hypertension. 5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease. 6. Unstable cardiovascular disorders.

Study sites (64)

CA

DE

FL

IA

ID

IN

KS

KY

MA

MD

MI

MO

NC

NE

NJ

NY

OH

OK

OR

PA

SC

TN

TX

UT

WA

WI

WV