Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma.

Running, not enrolling · Phase 3

Conditions studied: Severe Asthma

In brief

The objective of this study is to assess the potential for tezepelumab-treated patients (subcutaneous administration) to reduce maintenance therapy without loss of asthma control in adolescent and adults with severe asthma.. Study details include: 1. The study duration will be up to 72 weeks. 2. The treatment duration will be up to 68 weeks. 3. The visit frequency will be once every 4 weeks (Q4W).

Key facts

Study ID

NCT06473779

Run by

AstraZeneca

People needed

326

Starts

2024-09-30

Expected to finish

2027-06-25

Last updated by the study team

2026-06-15

Who can join

Age: 12 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Medical Conditions
• Any clinically important pulmonary disease other than asthma (eg, active lung infection, chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral EOS counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
• Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
• Affect the safety of the patient throughout the study
• Influence the findings of the study or the interpretation
• Impede the patient's ability to complete the entire duration of study.
• A helminth parasitic 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.
• Current smokers or patients with smoking history ≥ 10 pack-years and patients using vaping products, including electronic cigarettes. Former smokers with a smoking history of < 10 pack-years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.
• History of chronic alcohol or drug abuse within 12 months prior to Visit 1.
• Tuberculosis requiring treatment within the 12 months prior to Visit 1.
• History of known immunodeficiency disorder including a positive human immunodeficiency virus test at Visit 1, or the patient taking antiretroviral medications as determined by medical history and/or patient's verbal report.
• Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures requiring general anaesthesia or inpatient status for > 1 day during the conduct of the study.
• Evidence of COVID-19 within 4 weeks prior to screening or ongoing clinically significant COVID-19 sequelae.
• Prior/Concomitant Therapy
• Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational nonbiologic agent within 30 days or 5 half-lives (whichever is longest) prior to Visit 1.
• OCS-dependent patients (received chronic OCS therapy [prednisone ≥ 5 mg/day or equivalent]) for at least 3 months preceding Visit 1.
• Daily use of maintenance corticosteroids for any reason.
• Treatment with systemic immunosuppressive/immunomodulating drugs (eg, methotrexate, cyclosporine, etc.), except for OCS used in the treatment of asthma/asthma exacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) prior to Visit 1.
• Receipt of immunoglobulin or blood products within 30 days prior to Visit 1.
• Receipt of live attenuated vaccines 30 days prior to the date of Visit 1 and during the study.
• Patients that have been treated with bronchial thermoplasty in the last 12 months prior to Visit 1.
• Prior/Concurrent Clinical Study Experience
• Known history of sensitivity to any component of the tezepelumab formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
• History of anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy.
• Concurrent enrolment in another clinical study involving an IMP.

Where it is running

• Research Site — Colorado Springs, Colorado, United States
• Research Site — Miami, Florida, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — St Louis, Missouri, United States
• Research Site — New Brunswick, New Jersey, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — McAllen, Texas, United States
• Research Site — Berazategui, Argentina
• Research Site — CABA, Argentina
• Research Site — Concepción del Uruguay, Argentina
• Research Site — Mendoza, Argentina
• Research Site — Mendoza, Argentina
• Research Site — Quilmes, Argentina
• Research Site — Rosario, Argentina
• Research Site — Rosario, Argentina
• Research Site — San Miguel de Tucumán, Argentina
• Research Site — Santa Fe, Argentina
• Research Site — Anderlecht, Belgium
• Research Site — Edegem, Belgium
• Research Site — Erpent, Belgium
• Research Site — Ghent, Belgium
• Research Site — Liège, Belgium
• Research Site — Haskovo, Bulgaria
• Research Site — Pleven, Bulgaria
• Research Site — Palmdale, California, United States

Full record on ClinicalTrials.gov

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