A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

JRCT ID: jRCT2031230619

Registered date:07/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Obstructive Pulmonary Disease (COPD)
• Date of first enrollment: 21/02/2024
• Target sample size: 130
• Countries of recruitment: Canada,Japan,United States,Japan,Austria,Japan,Belgium,Japan,Bulgaria,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Kenya,Japan,Latvia,Japan,Netherlands,Japan,Poland,Japan,Romania,Japan,South Africa,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,Turkiye,Japan,United Kingdom,Japan,Australia,Japan,China,Japan,Hong Kong,Japan,India,Japan,New Zealand,Japan,Philippines,Japan
• Study type: Interventional
• Intervention(s): Astegolimab (RO7187807) is administered subcutaneously at 476 mg every2 weeks (Q2W) or every 4 weeks (Q4W).

Outcome(s)

• Primary Outcome: Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Documented COPD diagnosis for >= 12 months
2. History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening
3. Post-bronchodilator FEV1 >= 20% and < 80% of predicted at screening
4. Post-bronchodilator FEV1/FVC < 0.70 at screening
5. Modified Medical Research Council (dyspnea scale) (mMRC) score >= 2
6. Current tobacco smoker or former smoker with a history of smoking >= 10 pack-years
7. On optimized COPD maintenance therapy as defined below for >= 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
8. Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD

Exclude criteria

1. Current documented diagnosis of asthma
2. History of clinically significant pulmonary disease other than COPD
3. Diagnosis of 1-antitrypsin deficiency
4. History of long-term treatment with oxygen at > 4.0 liters/minute
5. Lung volume reduction surgery or procedure within 12 months prior to screening
6. Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
7. History of lung transplant
8. Any infection that resulted in hospital admission for >= 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
9. Upper or lower respiratory tract infection within 4 weeks prior to or during screening
10. Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
11. Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening
12. Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening

Related Information

• Primary Sponsor: Tsurumaki Sachi
• Secondary ID(s): NCT05595642