Tezepelumab Efficacy and Safety in Reducing Oral Corticosteroid Use in Adults With Oral Corticost… (NCT05398263) | Clinical Trial Compass
TerminatedPhase 3
Tezepelumab Efficacy and Safety in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma
Stopped: The study was discontinued due to slow recruitment, resulting from evolving clinical practices that reduced the use of maintenance oral corticosteroids for severe asthma treatment. The termination decision was not related to safety concerns.
United States, Brazil, Canada125 participantsStarted 2022-08-09
Plain-language summary
A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 28-week Phase 3 Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant must be 18 to 80 years of age.
. Documented physician-diagnosed asthma for at least 12 months prior to Visit 1.
. Participants must have received a physician-prescribed medium- or high-dose ICS for at least 12 months prior to Visit 1.
. Participants must have received physician prescribed LABA and high dose ICS for at least 3 months prior to Visit 1.
. Additional maintenance asthma controller medications are allowed. The use of these medications must be documented for at least 3 months prior to Visit 1.
. Participants must have received OCS for the treatment of asthma for at least 6 months prior to Visit 1 and on a stable dose of between ≥7.5 to ≤ 30 mg (prednisone or prednisolone) daily or daily equivalent for at least 1 month prior to Visit 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it was stopped early, and does that affect whether tezepelumab is still considered a safe or promising option for my OCS-dependent asthma?
2Since the goal of this trial was to help patients reduce their daily oral corticosteroid dose, are there other completed studies on tezepelumab that showed results for OCS reduction, and would those findings apply to my situation?
3Given that this was a Phase 3 trial that didn't finish, is tezepelumab already approved or available through other means for people like me who depend on oral corticosteroids to control their asthma?
4Because I rely on daily oral corticosteroids, what are the risks of staying on them long-term compared to exploring a biologic like tezepelumab, and is there a standard treatment path I should try first?
5Are there other active clinical trials or biologics specifically targeting OCS-dependent asthma that my care team thinks might be a better fit for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Subjects by Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 Whilst Maintaining Asthma Control.
. Morning pre- bronchodilator (BD) FEV1 must be \< 80% predicted normal at Visit 1 or Visit 2.
. Evidence of asthma as documented by either:
Exclusion criteria
. Any clinically important pulmonary disease other than asthma.
. Any disorder that is not stable in the opinion of the Investigator and could: a. Affect the safety of the participant throughout the study; b. Influence the findings of the study or the interpretation; c. Impede the participant's ability to complete the entire duration of study.
. History of cancer: a. Participants who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1; b. Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1.
. Asthma exacerbation, requiring use of systemic corticosteroids or increase in the maintenance dose of OCS finalized within 30 days prior to Visit 1.
. Clinically significant infection requiring treatment with systemic antibiotics or antiviral medications finalized \< 2 weeks before Visit 1 or during the run-in period.
. Participants with evidence of active COVID-19 infection during run-in period and optimisation.
. A helminth infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.
. A participant who is on SABA maintenance treatment within 30 days prior to Visit 1.