A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic obstructive pulmonary disease with (acute) exacerbation,
- Registration Number
- CTRI/2023/10/059272
- Lead Sponsor
- F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 4070 Basel, Switzerland
- Brief Summary
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of astegolimab in combination with standard of care (SOC) compared with placebo in combination with SOC, in participants with COPD who are former or current smokers and have a history of frequent exacerbations. Approximately 1290 participants with COPD are expected to be enrolled globally.
Following a screening period of at least 7 days and to up to 4 weeks, participants will be randomized in a 1:1:1 ratio to 1 of 3 treatment arms to receive blinded treatment with either astegolimab or placebo. Randomization will be stratified by smoking status at screening (former smoker vs. current smoker) and region. The first dose of study drug (astegolimab or placebo) will be administered on Day 1; treatment
will continue through Week 50, followed by a 12-week safety follow-up period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 1290
- Potential participants are eligible to be included in the study only if all of the following criteria apply:.
- Able and willing to provide written informed consent and to comply with the study protocol.
- Age 40-80 years at Visit 1.
- Documented COPD diagnosis for more than or equal to 12 months prior to Visit 1.
- History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to Visit 1.
- A moderate COPD exacerbation is defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) that lead totreatment with systemic corticosteroids (oral, IV, or intramuscular [IM]) and/or antibiotics. -Prior use of antibiotics alone does not qualify as a moderate exacerbation, unless the use was specifically for the treatment of worsening symptoms of COPD. -A severe COPD exacerbation is defined as new or increased COPD symptoms that lead to hospitalization (duration more than 24 hours) or lead to death.
- Post-bronchodilator FEV1 more than or equal to 20% and less than 80% of predicted at Visit 1 or Visit 2.
- Post-bronchodilator FEV1/FVC less than 0.70 at Visit 1 or Visit 2.
- mMRC score more than or equal to 2 at screening.
- Current tobacco smoker (see definition in Section 8.2.2) or former smoker (having stopped smoking for at least 6 months prior to Visit 1) with a history of smoking more than or equal to 10 pack-years (e.g., 20 cigarettes/day for 10 years).
- At Visit 1, participants who meet the protocol definition of current smoker will receive smoking cessation counseling (see Section 8.2.2).
- On optimized COPD maintenance therapy as defined below for more than or equal to 12 months prior to Visit 1. – Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA) – Long-acting muscarinic antagonist (LAMA) plus LABA – ICS plus LAMA plus LABA Participants must be stable on current medications and doses for at least 4 weeks prior to Visit 1. Initiation of new COPD therapy, including a methylxanthine preparation, maintenance macrolide therapy, and/or phosphodiesterase 4 (PDE4) inhibitor is not permitted within 4 weeks prior to Visit 1.
- Chest X-ray or computed tomography (CT) scan within 6 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 2) that confirms the absence of clinically significant lung disease besides COPD Demonstrated ability to use and comply with electronic diary (eDiary) requirements, defined as completion of all questions on at least 5 of 7 days prior to Visit 2 Participants unable to demonstrate compliance with the eDiary during the screening period will be screen failed. Participants will have the opportunity to demonstrate eDiary compliance if re-screened (see Section 8.3.3.3).
- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined below: Female participants must remain abstinent or use contraceptive methods with a failure rate of less than 1% per year during the treatment period and for 12 weeks after the final dose of astegolimab. A female participant is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (more than or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a female participant with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations. Examples of contraceptive methods with a failure rate of less than 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm, as defined below: With a female partner of childbearing potential or pregnant female partner, male participants must remain abstinent or use a condom during the treatment period and for 12 weeks after the final dose of astegolimab to avoid exposing the embryo. Male participants must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of preventing drug exposure. If required per local guidelines or regulations, information about the reliability of abstinence will be described in the local Informed Consent Form. For participants enrolled in the extended China enrollment phase at China’s sites: must be current residents of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry.
• Current documented diagnosis of asthma • History of clinically significant pulmonary disease other than COPD • Diagnosis of 1-antitrypsin deficiency • History of long-term treatment with oxygen at > 4.0 liters/minute • Lung volume reduction surgery or procedure within 12 months prior to screening • Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible) • History of lung transplant • 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 • Upper or lower respiratory tract infection within 4 weeks prior to or during screening • Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug • Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening • Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Annualized rate of moderate & severe COPD exacerbations over the 52 week 52 week treatment period. treatment period 52 week treatment period. A moderate COPD exacerbation is defined as new or increased COPD symptoms 52 week treatment period. (e.g. dyspnea, sputum volume, & sputum purulence) that lead to treatment 52 week treatment period. (duration more than or equal to 3 days) with systemic corticosteroids (oral, IV, or IM) at a dose of 52 week treatment period. more than 10 mg/day prednisolone equivalent and/or antibiotics. 52 week treatment period. A severe COPD exacerbation is defined as new or increased COPD symptoms that 52 week treatment period. lead to hospitalization (duration more than 24 hours) or lead to death. 52 week treatment period.
- Secondary Outcome Measures
Name Time Method 1. Time to first moderate or severe COPD exacerbation during the 52 week treatment period
Trial Locations
- Locations (26)
Aakash Healthcare Super Specialty Hospital
🇮🇳Delhi, DELHI, India
Apollo Speciality Hospital Pvt. Ltd
🇮🇳Dehat, UTTAR PRADESH, India
Clinical Trial Unit MRU (Multidisciplinary Research Unit
🇮🇳Faridabad, HARYANA, India
Criti Care Hospital & Research Institute
🇮🇳Nagpur, MAHARASHTRA, India
GMERS Medical college & Hospital, Gotri
🇮🇳Vadodara, GUJARAT, India
GMERS Medical College and Civil Hospital, Sola
🇮🇳Ahmadabad, GUJARAT, India
Government Chest Disease Hospital
🇮🇳JAMMU, & KASHMIR, India
Government Medical College
🇮🇳Kozhikode, KERALA, India
Government Medical College and Government General Hospital
🇮🇳Srikakulam, ANDHRA PRADESH, India
Institute of Post Graduate Medical Education and Research and SSKM Hospital
🇮🇳Kolkata, WEST BENGAL, India
Scroll for more (16 remaining)Aakash Healthcare Super Specialty Hospital🇮🇳Delhi, DELHI, IndiaDr Prabhat Ranjan SinhaPrincipal investigator01143388888drprabhat.ranjan@aakashhealthcare.com