A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma

JRCT ID: jRCT2031230185

Registered date:27/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Moderate to Severe Asthma
• Date of first enrollment: 21/07/2023
• Target sample size: 240
• Countries of recruitment: Canada,Japan,Germany,Japan,Poland,Japan,Spain,Japan,United States,Japan,Argentina,Japan,Belgium,Japan,Republic of Korea,Japan
• Study type: Interventional

Intervention(s)

- ICS-LABA + povorcitinib Dose 1
- ICS-LABA + povorcitinib Dose 2
- ICS-LABA + povorcitinib Dose 3
Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 1, 2 or 3 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
- ICS-LABA+placebo
Participants will receive stable background therapy with ICS-LABA in combination with placebo once daily (QD) for 24 weeks during the placebo-controlled period. Participants will be allocated to 1 of 3 doses of povorcitinib during the extension period of 28 weeks

Outcome(s)

• Primary Outcome: Absolute change in pre-BD FEV1 [ Time Frame: Baseline ; Week 24 ]

Secondary Outcome

1. Number of asthma exacerbations during the Placebo Controlled (PC) period [ Time Frame: Up to 28 weeks ]
2. Absolute change from baseline in pre-BD FEV1 at each visit [ Time Frame: Up to 14 months ]
3. Percent change from baseline in pre-BD FEV1 at each visit [ Time Frame: Up to 14 months ]
4. Absolute change from baseline in post-BD FEV1 at week 24 [ Time Frame: Baseline; Week 24 ]
5. Percent change from baseline in post-BD FEV1 at week 24 [ Time Frame: Baseline; Week 24 ]
6. Absolute change from baseline in pre-BD FVC at each visit [ Time Frame: Up to 14 months ]
7. Percent change from baseline in pre-BD FVC at each visit [ Time Frame: Up to 14 months ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1. Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABA for at least 12 months prior to screening.
2.Pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1) < 80% predicted according to central over read value at Visit 2.
3. Documented historical post-BD reversibility of FEV1 >= 12% and >= 200 mL in FEV1 within 12 months prior to screening OR Post-BD reversibility of FEV1 >= 12% and >= 200 mL in FEV1 according to central over read value at Visit 2.
4. At least 2 documented asthma exacerbations (requiring treatment with systemic corticosteroid (CS), hospitalization, or emergency department visit) within 12 months prior to screening but not within the past 4 weeks prior to screening.
5. ACQ-6 >= 1.5 at screening.

Exclude criteria

1. Maintenance use of asthma controllers other than ICS-LABA.
2. Have undergone bronchial thermoplasty.
3. Current smokers or participants with a smoking history of >= 10 pack-years and participants using vaping products, including electronic cigarettes.
4. Women who are pregnant (or who are considering pregnancy) or breastfeeding.
5. Current conditions or history of other diseases, as follows:
- Clinically important pulmonary disease other than asthma ,Thrombocytopenia, coagulopathy, or platelet dysfunction.
- Venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, moderate to severe heart failure (NYHA Class III or IV), cerebrovascular accident, myocardial infarction, coronary stenting, or CABG surgery.
- Diagnosis of other significant cardiovascular diseases, including but not limited to angina, peripheral arterial disease, or uncontrolled arrhythmias such as atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and forms of carditis.
- Recipient of an organ transplant that requires continued immunosuppression.
- Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
- Any malignancies or history of malignancies. Note: Participants with cured nonmetastatic basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy or cancers from which the participant has been disease-free for > 1 year after treatment with curative intent are eligible.
- Chronic or recurrent infectious disease.
6. Receipt of any biologic drugs used for asthma < 12 weeks or 5 half-lives (if known), whichever is longer, prior to screening.

Related Information

• Primary Sponsor: Ueda Eiji
• Secondary ID(s): NCT05851443