A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

JRCT ID: jRCT2031240596

Registered date:07/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Obstructive Pulmonary Disease (COPD)
• Date of first enrollment: 07/01/2025
• Target sample size: 110
• 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 every 2 weeks (Q2W).

Outcome(s)

• Primary Outcome: Incidence and severity of adverse events, with severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (hereafter referred to as the DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 90age old
• Gender: Both
• Include criteria: 1. Completion of the 52-week treatment period in either parent GB43311 or GB44332

Exclude criteria

1. Withdrawal of consent and/or premature discontinuation from parent study
2. Any permanent discontinuation of study drug in parent study
3. Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment
4. Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study
5. Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study
6. Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study

Related Information

• Primary Sponsor: Nishioka Tsuyoshi
• Secondary ID(s): NCT05878769