TERESA study (TERESA study)

JRCT ID: jRCTs071230026

Registered date:20/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: uncontrolled severe asthma
• Date of first enrollment: 03/07/2023
• Target sample size: 105
• Study type: Interventional
• Intervention(s): Tezepelumab (210 mg/dose) is subcutaneously given at 4-week intervals and continued for 104 weeks or until criteria for protocol treatment discontinuation are met. After met the criteria for discontinuation of protocol treatment, follow-up according to the study protocol will continue for 104 weeks or criteria for discontinuation of study participation are met.

Outcome(s)

• Primary Outcome: Proportion of patients in clinical remission at 52 weeks of treatment.

Secondary Outcome

1. Proportion of patients in clinical remission at 24, 72 and 104 weeks of treatment.
2. Proportion of patients in clinical remission at both 24 and 52 weeks of treatment or 52 and 104 weeks of treatment.
3. Proportion of patients in clinical remission at 24, 52, 76 and 104 weeks of treatment who were not receiving systemic corticosteroids as maintenance therapy on the date of initiation of treatment.
4. Proportion of patients in complete remission at 24, 52, 76 and 104 weeks of treatment.
5. Proportion of patients in complete remission at both 24 and 52 weeks of treatment or 52 and 104 weeks of treatment.
6. Proportion of patients in complete remission at 24, 52, 76 and 104 weeks of treatment who were not receiving systemic corticosteroids as maintenance therapy on the date of initiation of treatment.
7. Change in type 2 biomarkers, symptoms and pulmonary function from baseline to 24, 52, 76 and 104 weeks of treatment (ACQ-6 score, pre-bronchodilator percent predicted FEV1, peripheral blood eosinophil count, serum total IgE levels, fractional exhaled nitric oxide levels).
8. Proportion of patients in low disease activity at 24, 52, 76 and 104 weeks of treatment.
9. Annual asthma exacerbation rates up to 52 and 104 weeks of treatment.
10. Proportion of patients in clinical remission at all 24, 52, 76 and 104 weeks of treatment.
11. Proportion of patients in complete remission at all 24, 52, 76 and 104 weeks of treatment.
12. Classification of patients in low disease activity, clinical remission, complete remission or none at 52 and 104 weeks, and confirmation of the transition.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients diagnosed with severe asthma by a respiratory physician and receiving middle- or high-dose inhaled glucocorticoids plus additional controller medication. (Patients treated with or without a history of biologics use, however, as long as possible more than 4 months elapsed between the last dose of the previous biological agent and the start of protocol treatment.)
2.Patients treated with systemic corticosteroids as maintenance therapy for asthma at a PSL equivalent of 5 mg/day or less.
3.Patients aged 20 years or older at the time of obtaining consent.
4.Patients with uncontrolled asthma who fulfill one of the following conditions.
i) History of at least one asthma exacerbation within 6 months before the date of obtaining consent
ii) 1.5< Asthma Control Questionnaire-6 (ACQ-6) score <=3.5 within 2 months before the date of consent
iii) 60% predicted <= FEV1 <80% predicted within 2 months before the date of obtaining consent
5.Patients who are able to provide informed written consent prior to enrolment in the study.

Exclude criteria

1. Patients diagnosed with any clinically significant pulmonary diseases other than asthma (e.g., chronic obstructive pulmonary disease) or pulmonary or systemic diseases due to increased peripheral blood eosinophil counts (e.g., chronic eosinophilic pneumonia, allergic bronchopulmonary mycosis, eosinophilic granulomatosis with polyangiitis).
2. Patients diagnosed with a parasitic infection within 6 months before obtaining consent who were not treated with standard treatment or who did not respond to treatment.
3. Patients with comorbidities requiring systemic corticosteroids or immunosuppressive treatment.
4. Patients with a history of anaphylaxis or immune complex disease (type III hypersensitivity reaction) following treatment with biological agents.
5. Female patients who are pregnant or may become pregnant. Female patients who are lactating.
6. Patients deemed by the responsible physician to be unsuitable for the study.

Related Information

• Primary Sponsor: Okamoto Isamu
• Source(s) of Monetary Support: AstraZeneca K.K.